Bilateral Paravertebral Block versus Thoracic Epidural Analgesia for Pain Control Post-Cardiac Surgery: A Randomized Controlled TrialFund None. The pain management represents the standard of care in the participating centers.
Trial Registration Number PACTR201603001502110 (www.pactr.org).
02 March 2018
05 July 2018
16 August 2018 (online)
Background Adequate pain control after cardiac surgery is essential. Paravertebral block is a simple technique and avoids the potential complications of epidural catheters. The objective of this study is to compare the effect of ultrasound-guided bilateral thoracic paravertebral block with thoracic epidural block on pain control after cardiac surgery.
Materials and Methods Between March 2016 and 2017, 145 patients who had cardiac surgery through median sternotomy were randomized by stratified blocked randomization into two groups. Group I (n = 70 patients) had bilateral ultrasound-guided thoracic paravertebral block and Group II (n = 75 patients) had thoracic epidural analgesia. The primary end point was the postoperative visual analogue scale (VAS). The duration of mechanical ventilation, intensive care unit (ICU), and hospital stay were the secondary end points. The study design is a randomized parallel superiority clinical trial.
Results Both groups had similar preoperative and operative characteristics. No significant difference in VAS measured immediately after endotracheal extubation then after 12, 24, and 48 hours between groups (p = 0.45). Pain score significantly declined with the repeated measures (p < 0.001) and the decline was not related to the treatment group. Postoperative pain was significantly related to diabetes mellitus (p = 0.039). Six patients in group I (8.5%) required an additional dose of morphine versus three patients (4%) in group II (p = 0.30). Patients in group I had significantly shorter ICU stay (p = 0.005) and lower incidence of urinary retention (p = 0.04) and vomiting (p = 0.018). No difference was found in operative complications between groups.
Conclusion This randomized parallel controlled trial demonstrates that ultrasound-guided paravertebral block is safe and effective method for relieving post-cardiac surgery sternotomy pain compared with thoracic epidural analgesia but not superior to it.
Hatem A. El Shora: study design and trial registration, supervised data collection and coordinated work between the participating centers, wrote the first manuscript, critically revised and approved the final manuscript. Moreover, he modified the manuscript in response to the reviewer's comments. Ahmed A. El Beleehy: participated in study design and was responsible for the administrative work for local trial registration and getting Ethical Committee approval, performed literature review, drafted the manuscript, revised and approved the final manuscript. Amr A. Abdelwahab: data acquisition in center 1, shared in final interpretation of the statistical analysis, critically revised the first draft, revised and approved the final manuscript. Gaser Ali: collected data in center 2, supervised the initial statistical analysis and data interpretation, critically revised the first and final manuscript. Tarek E. Omran: collected data from center 1, revised the collected data and ascertained the consistency and accuracy of the collected data from both centers, critically revised the draft and final manuscript. Essam A. Hassan: supervised patient's enrollment, consent and flow of the study, revised and interpreted the results of the statistical analysis, critically revised the first draft and approved the final draft. Moreover, he drafted the response to the reviewers. Amr A. Arafat: participated in the study design and sample size calculation, revised the statistical analysis, performed additional statistical tests and made the final interpretation of the data, revised the first draft and wrote the final version of the manuscript.
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