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Effects of oral clonidine on bleeding in pelvic and acetabular fractures surgery: a randomized controlled trial

BMC Musculoskeletal Disorders volume 26, Article number: 384 (2025) Cite this article

Abstract

Background

High blood loss results in major complications in pelvic and acetabular surgeries. Decrement of blood loss during and after surgery reduces morbidity and mortality of the patients. Clonidine is an antihypertensive alpha-2 agonist that has been shown to reduce blood loss in different surgeries. This study aims to evaluate the effects of preoperative oral administration of clonidine in patients who underwent surgery for pelvic and acetabulum fractures.

Methods

A randomized, triple-blinded clinical trial was conducted on 88 patients (79 men and 9 women) scheduled for pelvic or acetabular fracture surgery. Patients were divided into two groups. The intervention group received 200 mcg of oral clonidine 75 to 90 min before anesthesia. Control groups received a placebo with a similar color and shape to clonidine. We compared two groups regarding the blood loss volume, postoperative pain, quality of the surgical visual field, and day one and three postoperative hemoglobin levels.

Results

Postoperation hemoglobin level was significantly dropped in both groups (P < 0.05). Post-surgery, the hemoglobin level difference between the groups increased and became significant by day three (9.8 ± 1.2 Vs. 8.4 ± 1.2, P = 0.02). The number of patients who required postoperative blood transfusion in the intervention group was less than in the control group (3 vs. 10, P = 0.03). Preoperative clonidine significantly reduced postoperation pain and improved the quality of the surgeon’s visual field (P < 0.001).

Conclusions

Preoperative oral clonidine administration reduced blood loss and the number of postoperative transfusion units in pelvic and acetabular fracture surgeries. In addition, it improved the surgeon’s visual field quality and reduced postoperative pain.

Peer Review reports

Introduction

Acetabular and pelvic fractures usually occur following a high-energy trauma and are associated with considerable complications [1, 2]. Bleeding is an inevitable but controllable complication during and after surgery. Pelvic and acetabular fractures can lead to substantial hemorrhage not just originating from the site of the fracture but also from significant blood vessels or nearby organs in proximity to the affected area. Hypovolemic shock has been identified as a primary contributor to fatality among acetabular and pelvic fracture patients [3]. Blood loss during surgery increases the need for a blood transfusion, which causes different adverse reactions such as transfusion-related infection, hemolysis, and allergic reactions [4, 5].

It is well known that deliberate hypotension during surgery can decrease blood loss, decrease intraoperative bleeding, shorten surgery time, and improve the visual field intraoperatively [6,7,8]. Nevertheless, inducing hypotension should be performed under control and caution, considering the potential risk of hypoxia in different organs [9]. Several methods are considered to decrease blood loss during orthopedic surgeries and the postoperative period, including proper surgical techniques, effective hypotensive anesthesia techniques [10], antifibrinolytic drugs such as different forms of tranexamic acid [11,12,13], and antihypertensive drugs [14, 15].

Clonidine is an antihypertensive agent acting on alpha-2 adrenergic in the central nervous system [16]. Clonidine reduces blood pressure and heart rate by dilating the arteries. As a result of its antihypertensive properties, it is considered a promising drug to control blood pressure and reduce blood loss during surgeries [17,18,19]. The effect of clonidine as an agent for controlling blood loss during orthopedic surgeries has been evaluated in spine surgeries [20, 21]. However, its potential effects on reducing blood loss and pain management remained unclear in other orthopedic surgeries, especially pelvic and acetabulum fractures.

The present randomized controlled study aims to examine the effects of clonidine on bleeding in patients undergoing surgery for pelvic or acetabulum fractures. We hypothesized that preoperative oral clonidine may decrease blood loss in these patients. Considering clonidine’s effects on blood loss and pain management, to our knowledge, this study is the first randomized controlled trial to evaluate clonidine’s effects on bleeding and postoperative pain of pelvic and acetabular trauma surgeries.

Materials and methods

Study design

This study is a randomized, triple-blinded, controlled trial carried out on patients referred to a tertiary hospital from March 2022 to December 2023 and diagnosed with a pelvic or acetabular fracture using plain radiographs. All participants provided written informed consent. This study was performed in line with the principles of the Declaration of Helsinki and Shahid Beheshti University of Medical Sciences ethics guidelines (IR.SBMU.RETECH.REC.1400.890). Our institutional ethics review board approved this randomized controlled trial (registered under trial registration number: IRCT20150221021171N2, Registration date: 2022-03-08).

Participants

The inclusion criteria were defined as patients aged more than 18 with Pelvic or Acetabular fractures that required open fixation. The exclusion criteria were as follows: minimal invasive surgeries with less than 300 ml possible blood loss, simultaneous fracture of acetabular and pelvic ring, being in pregnancy or of the lactation period, open fracture, multiple trauma and patients with trauma to other organs or significant blood loss in other organs, preoperative anticoagulant or antiplatelet or antifibrotic consumption, clotting disorders including abnormal PT, PTT or INR, substance and opium usage, alcoholics, diabetes, renal or liver impaired function, a history of cerebrovascular disease like the previous stroke, a history of cardiovascular disease like myocardial infarction or atrial fibrillation or heart failure, history of thromboembolic events like deep vein thrombosis (DVT) or pulmonary embolism (PE), or arterial stenosis with or without concomitant coronary artery bypass grafting, history of uncontrolled blood pressure, a history of previous organ necrosis due to ischemia and hypoxia such as mesenteric ischemia, the preoperative hemoglobin < 10 g/dL [22], preoperative blood pressure lower than 90/60 mmHg, patients who needed to have any intraoperative blood pressure modulator, patients that were taking medication with hazardous interaction with clonidine, and contraindications of clonidine consumption, for instance, prolonged PR, atrioventricular block, spontaneous bradycardia, history of allergic reaction to clonidine and history of beta-blockers or calcium channel blockers intake.

Randomization and blindness

Patients were randomly allocated into two groups based on whether they received preoperative clonidine or placebo using the Covariate adaptive randomization method considering gender and Body mass index (BMI) as covariates [23]. The patient, surgeon, nurses, care providers, and analyzer were blinded throughout the study, and the anesthesia team randomly allocated patients. Patients in the intervention group received 200 mcg oral clonidine 75 to 90 min before anesthesia. This period warrants maximum plasma concentrations after oral consumption of the drug [21]. Control groups received a placebo with a similar color and shape to clonidine. Of 145 patients, 89 had the criteria to be enrolled in the study. One patient was lost to follow-up due to not having third-day lab tests. The final number of patients in the study included 44 patients in the control group and 44 patients in the treatment group (Fig. 1).

Surgery and perioperative consideration

All patients were operated on by the same surgeon (single center and single surgeon). The posterior pelvic ring was fixed in patients with a pelvic fracture, applying close reduction and internal fixation using one or two sacroiliac screws. The anterior pelvic ring in these patients was fixed using a reconstruction plate via the anterior approach in all patients [24]. In patients with an acetabular fracture, the modified Stoppa and Kocher-Langenbeck approaches were used to fix fractures of the anterior and posterior columns, respectively [25]. Surgery was performed under general anesthesia. Anesthesia was performed with drugs, including Sodium Thiopental Lidocaine, Midazolam, Fentanyl, and N2O gas, while the doses were adjusted according to the patient’s body weight. If patients were admitted more than a day before surgery, they received prophylactic anticoagulant treatment with Low molecular weight heparin (LMWH) and mechanical compression devices until 12 h before surgery, and if they had no uncontrollable bleeding after surgery, the same anticoagulant treatment was started one day after surgery. In the case of pain control needs in patients, acetaminophen was administrated similarly in all patients.

The postoperative packed-cell transfusion threshold was considered a hemoglobin level of ≤ 7 g/dL or < 8 g/dL with symptoms of anemia (defined as light-headedness, fatigue, palpitation, or shortness of breath), and the number of transfusions was recorded [26, 27]. Intraoperative indications for transfusion were based on acute blood loss and blood pressure drop during the surgery that did not respond to inotropic medications or increased intravenous fluid administration with crystalloids such as normal saline or Ringer’s lactate [28,29,30]. However, no intraoperative blood transfusions were required in this study group.

Fig. 1
figure 1

Flow diagram of participants in this randomized clinical trial

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Outcomes and data collection

Types of pelvic fractures were defined by the Young and Burgess classification [31] and acetabular fractures by the Letournel classification [32]. The following data were also recorded: age, gender, BMI, type of surgery, duration of surgery, preoperative coagulation tests, hemoglobin, and hematocrit levels before and (one and three days) after the surgery.

The amount of blood loss during and after surgery was recorded. Total blood loss was considered as intra- and postoperative visible and hidden blood loss. Intraoperative blood loss was calculated using suctioned liquid during surgery and used swabs. Liquids used during surgery, such as normal saline, were considered when calculating total blood loss. A full blood swab (gauze) was considered to be 160 ml of blood [33, 34]. Surgical drains were used, and on the next day after surgery, if the overall postoperative blood loss was less than 60 ml, they were removed.

The operation duration was considered the time between the skin incision and the final skin suture. To evaluate the patients’ postoperative pain index on day one after surgery, the Visual Analogue Scale (VAS) (from point 0, “No Pain” to point 10, “Unbearable Pain”) was used. To assess the quality of the surgical visual field, an 11-point visual analog scale (0 = best possible operating conditions and dryness of the surgical field; 10 = worst possible conditions) was used, and the surgeon was asked to complete this score for each patient at the end of surgery [35].

Patients were monitored for clonidine side effects such as possible bronchospasm, arrhythmia, hypercapnia, and rebound hypertension. Also, early postoperation complications, such as unplanned ICU admission, and mortality were recorded.

Statistical analysis

Based on Meand ± standard deviation (SD) of the blood loss volume in a similar study and using Gpower software version 3.1, setting a 95% confidence level and 95% test power and α = 0.05, we calculated a minimum sample size of 36 patients per treatment arm and considering a 10% drop in each arm, a total of 80 patients were considered appropriate sample size for the study [36].

Data were analyzed using SPSS version 29 (IBM Corp., Armonk, NY). The Kolmogorov-Smirnov test was used to evaluate the normal distribution of continuous variables. Parametric data were expressed as mean ± standard deviation (SD) and analyzed by independent t-test, paired t-test, one-way ANOVA, and repeated measurement analysis of variance. Nonparametric data were analyzed using the Mann-Whitney U, Wilcoxon Signed Rank, and Kruskal–Wallis tests. Chi-square tests were used to analyze categorical data. The correlation between variables was evaluated using Pearson and Spearman correlation. A P-value < 0.05 was considered statistically significant.

Results

Of the 88 patients included in the study, 9 (10.2%) were female, and 79 (89.8%) were male. The mean age of the patients was 38.22 ± 10.11 years, and the mean BMI was 26.42 ± 3.42 kg/m2. There were no statistically significant differences in sex, age, and BMI between the two groups (P > 0.05) (Table 1). Preoperative coagulation test results are shown in Table 2.

Table 1 Demographic variables of patients
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Table 2 Preoperative coagulant tests
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Of the patients, 36 (40.9%) had pelvic fractures, and 52 (59.1%) had acetabular fractures. The most common types of fractures were both column fractures in 30 (34.1%) and lateral compression type 2 fractures in 25 (28.5%) patients (Table 3). The two groups had no significant difference regarding the fracture type and the surgical approach (P > 0.05).

Table 3 Comparison of fracture types between two groups.
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Table 4 Comparison of hemoglobin levels preoperatively and 1st and 3rd-day postoperatively. (mean ± SD)
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The mean preoperative hemoglobin level in the intervention group was 11.93 ± 1.1, and in the control group was 12.34 ± 1.8 (P > 0.05). Our results demonstrated a significant decrease in hemoglobin levels on day three after surgery compared to the preoperative level in both groups (P < 0.05). In postoperative hemoglobin levels, the difference between both groups increased constantly, and it was statistically significant on day three (P = 0.027) (Table 4). Contrary to the intervention group, the hb level in the control group on day three dropped significantly compared to day one (P = 0.03)

According to the VAS index for pain assessment, there was a significant difference between the intervention and the control group (P < 0.001). Despite higher intraoperative bleeding volume in the control group than intervention (P < 0.001), postoperative bleeding was not significantly different between the groups (P = 0.38). Surgical drains were removed in all patients in both groups on the day after surgery. Postoperative transfusion units in the control group were significantly more than in the intervention group (P = 0.03). There was a significant difference in the surgeon’s visual field quality based on the VAS score between the two groups (P < 0.001) (Table 5).

The duration of surgery in the intervention group was lower than the control group, but it was not statistically significant (0.68) (Table 5). Regarding surgical approaches, the duration of surgery was 42.2 ± 11.4, 80.0 ± 8.8, and 50.4 ± 7.2 for the anterior approach in pelvic ring fracture, Stoppa, and Kocher-Langenbeck approach in acetabular fracture, respectively (P < 0.001). The duration of surgery was not significantly different between the intervention and control groups regarding each surgical approach (P > 0.05).

The correlation analysis between surgery duration with intraoperative blood loss and visual field quality was not statistically significant (P > 0.05). There was a significant correlation between intraoperative blood loss with visual field quality and pain VAS score (r = 0.973, p = P < 0.001, and r = 0.932, p = P < 0.001, respectively).

Table 5 Pain index, bleeding volume, rate of transfusion, and surgical field quality. (mean ± SD)
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Discussion

This study showed that preoperative administration of oral clonidine before anesthesia in patients with pelvic or acetabular fractures could reduce postoperative hemoglobin drop and help surgeons have a better field of surgery. It also helped the patients to have better postoperative pain control.

Bleeding is a common complication during orthopedic surgery, particularly surgeries involving long bones and the pelvis, which could cause massive blood loss and be life-threatening [37]. Controlled hypotension is proposed to reduce blood loss intraoperatively [8, 38]. Clonidine is an agonist of alpha-adrenergic post-synaptic receptors, which is used as an antihypertensive drug suppressing sympathetic activity [39].

Several studies revealed the role of clonidine in decreasing blood loss during different types of surgeries [19, 40,41,42]. In a randomized clinical trial on 160 patients undergoing femoral fracture surgery, the effect of clonidine on intraoperative bleeding was evaluated; it was demonstrated that administration of oral clonidine 5 µg/kg 90 min before surgery decreased blood loss intraoperatively [43]. We also found that intraoperative blood loss and transfusion rates were significantly lower in the intervention group using clonidine than in the control group.

A prospective, randomized, double-blind clinical trial by Marchal et al. on 40 patients who underwent elective middle ear microsurgery revealed that receiving 300 mcg clonidine orally 90 min before operation significantly reduced bleeding compared with the control group and also attenuated fentanyl requirement, mean arterial pressure, heart rate, and postoperative pain. They evaluated bleeding with a four-point scale from 0 = no bleeding (excellent surgical conditions) to 3 = abundant (troublesome) bleeding (continuous suction) and found that the surgical field was cleaner in the clonidine group [18]. Similarly, a significant difference between clonidine and the control group regarding the quality of the surgeon’s visual field was found in the present study. However, another pilot study on the quality of the surgical field during endoscopic sinus surgery for chronic sinusitis and polyps removal in 26 patients revealed the same result of improving field visualization, evaluated by Boezaart score, following premedication with clonidine [44, 45].

Various possible mechanisms have been introduced to explain the effect of clonidine on reducing blood loss pre- and postoperatively. One possible explanation is that clonidine decreases blood loss by decreasing blood flow as an antihypertensive agent [46]. Clonidine is also known for reducing postoperative pain and as an effective anxiolytic drug in combination with other anesthetic agents [18, 47, 48].

Numerous studies have indicated that preoperative [49, 50] or postoperative [51,52,53] administration of clonidine could be effective in pain relief. Pain and stress can cause a delay in wound healing [54, 55], which can cause more blood loss after surgery; accordingly, clonidine’s effects on decreasing blood loss may be attributed to its anti-anxiety and pain-relieving properties. A recent randomized controlled trial showed that Oral clonidine significantly reduced pain and the need for morphine in patients with orthopedic fractures [56]. In this study, data showed that preoperative consumption of clonidine declined postoperative pain after pelvic and acetabular surgeries, as indicated by the VAS scoring system.

This study is the first randomized controlled trial to evaluate the effects of preoperative clonidine usage in pelvic and acetabular fracture patients. Results revealed an acceptable effect of clonidine on reducing surgical blood loss and postoperative pain and increasing the surgeon’s visuality during surgery.

We faced some limitations in this study. The number of males and females was not equivalent, and males were dominant, so the results may not accurately represent both genders. Just one dosage of clonidine was used in this study, and further evaluation is needed to address the best dosage and protocol of preoperative clonidine for patients. Regarding objective evaluation, only pain scores were asked, so evaluating more patients’ reported outcomes is suggested. Further studies are required to evaluate the effect of clonidine in simultaneous pelvic and acetabular fractures. Evaluating intraoperative and postoperative repeated measurements of blood pressure, mean arterial pressure (MAP), and heart rate to reach a better understanding of the effect and side effects of clonidine in patients. This study only evaluated intraoperative and early postoperative complications, so it would be better to have a long-term follow-up to evaluate the clonidine effects on pain, sequent wound healing, hospital readmission, reoperation, mortality, and other complications. In this study, only the effect of clonidine alone was evaluated, so it is recommended to evaluate the effect of the combination of different techniques added to clonidine to reach the best protocol for blood loss control and reducing postoperative pain.

Conclusion

This randomized, triple-blinded clinical trial showed that preoperative consumption of clonidine can effectively reduce the need for blood transfusion. Premedication with clonidine also improved the visual quality of the surgical field and decreased postoperative pain. Therefore, clonidine could be considered a drug of choice to reduce bleeding during and after orthopedic surgeries.

Data availability

The datasets generated and/or analysed during the current study are not publicly available due to the rules of our institute but are available from the corresponding author on reasonable request.

Abbreviations

BMI:

Body mass index

VAS:

Visual Analogue Scale

DVT:

Deep Vein Thrombosis

PE:

Pulmonary Embolism

BT:

Bleeding Time

PT:

Prothrombin time

PTT:

partial Thromboplastin time

Plt:

Platelet count

Hb:

Hemoglobin

LC2:

Lateral compression type 2

LC3:

Lateral compression type 3

APC2/3:

Anterior Posterior Compression type 2/3

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Acknowledgements

We want to thank the nursing staff in our department who helped us to facilitate the administration of treatment and placebo to patients.

Funding

No funding was received to assist with the preparation of this manuscript.

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Authors and Affiliations

  1. Clinical Research Development Unit of Akhtar Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran

    Mohamad Qoreishy

  2. Bone Joint and Related Tissues Research Center, Akhtar Orthopedic Hospital, Shahid Beheshti University of Medical Sciences, Sharifi Manesh Street, Shariati Street, Tehran, Iran

    Alireza Mirahmadi, Mohammad Movahedinia, Sohrab Keyhani, Arash Maleki & Bahram Naghibi

Authors
  1. Mohamad Qoreishy
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  2. Alireza Mirahmadi
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  3. Mohammad Movahedinia
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Contributions

M.Q, B.N, A.M, M.M, A.M, and S.K designed the study. M.Q performed surgeries. B.N carried out the postoperative visits. M.M did the analysis. A.M drafted the manuscript. M.M, S.K, and A.M prepare the final revision of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Bahram Naghibi.

Ethics declarations

Ethics approval and consent to participate

This study was performed per the principles of the Declaration of Helsinki and “Shahid Beheshti University of Medical Sciences” ethics guidelines (IR.SBMU.RETECH.REC.1400.890). Our institutional ethics review board approved this randomized controlled trial, registered under trial registration number (IRCT20150221021171N2). Written informed consent was obtained from all patients before initiation of the study.

Consent for publication

Not Applicable.

Competing interests

The authors declare no competing interests.

Clinical trial registration

IRCT20150221021171N2, 2022-03-08.

Ethical committee approval

IR.SBMU.RETECH.REC.1400.890.

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Qoreishy, M., Mirahmadi, A., Movahedinia, M. et al. Effects of oral clonidine on bleeding in pelvic and acetabular fractures surgery: a randomized controlled trial. BMC Musculoskelet Disord 26, 384 (2025). https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12891-025-08558-3

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  • DOI: https://doiorg.publicaciones.saludcastillayleon.es/10.1186/s12891-025-08558-3

Keywords

BMC Musculoskeletal Disorders

ISSN: 1471-2474

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