Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 27, 2017
Open Peer Review Period: Oct 28, 2017 - Feb 19, 2018
Date Accepted: Feb 28, 2018
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Effects of Deep Versus Moderate Neuromuscular Blockade in Laparoscopic Gynecologic Surgery on Postoperative Pain and Surgical Conditions: Protocol for a Randomized Controlled Trial
Background:
Postoperative pain, especially shoulder pain, is commonly reported after laparoscopic gynecologic procedures. Some studies suggest that a lower insufflation pressure may reduce the risk of postoperative pain; however, there is no agreement on the optimal pneumoperitoneum pressure during gynecologic laparoscopic surgery or whether lower pressure would lead to clinically significant improvements without increasing operative complications. Questions remain regarding the clinical significance of improvements, safety, and cost-effectiveness of deep neuromuscular blockade with low-pressure pneumoperitoneum.
Objective:
The primary objective of this study was to assess the superiority of anesthesia with deep neuromuscular blockade with pneumoperitoneum 8 mm Hg over moderate blockade with pneumoperitoneum 12 mm Hg in terms of overall pain 24 hours after surgery in adult women undergoing pelvic surgery for hysterectomy or benign adnexal diseases. Effects on the intensity and timing of postoperative pain in specific locations, surgeon satisfaction, respiratory and hemodynamic stability, operating times, and direct and indirect costs will be assessed.
Methods:
In this multicenter, randomized controlled trial with a superiority design, 300 patients will be randomly allocated in the ratio 1:1 to moderate neuromuscular blockade with a target insufflation pressure of 12 mm Hg or deep neuromuscular blockade with a target insufflation pressure of 8 mm Hg, with stratification by type of surgery and clinical center. The patient, the statistician, and the nurse who will assess the primary endpoint will be blinded to the allocation.
Results:
Recruitment to this trial is expected to open in June 2018 and is expected to close in June 2019.
Conclusions:
This study is designed to confirm the reported benefits of postoperative pain and provide additional data needed to address questions regarding the effects of this intervention on operating theater management and direct and indirect costs. Strengths of this protocol include the large sample size distributed among diverse institutions across the Italian territory and the collection and analysis of data on numerous secondary objectives. Limitations include the possible introduction of bias because the surgeon and anesthesiologist are not blinded to the intervention.
International Registered Report:
RR1-10.2196/9277
Citation
Per the author's request the PDF is not available.
Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.