Effects of Deep Versus Moderate Neuromuscular Blockade in Laparoscopic Gynecologic Surgery on Postoperative Pain and Surgical Conditions: Protocol for a Randomized Controlled Trial (Preprint)

Abstract

Post-operative pain, especially shoulder pain, is commonly reported following laparoscopic gynecologic procedures. Some studies suggest that a lower insufflation pressure may reduce the risk of post-operative 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.The primary objective of this study is to assess the superiority of anesthesia with deep neuromuscular blockade with pneumoperitoneum 8 mmHg over moderate blockade with pneumoperitoneum 12 mmHg, in terms of overall pain 24 hrs 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 haemodynamic stability, operating times and direct and indirect costs will be assessed.In this multicenter, randomized controlled trial with a superiority design, 300 patients will be randomly allocated 1:1 to moderate neuromuscular blockade with a target insufflation pressure of 12 mmHg or deep neuromuscular blockade with a target insufflation pressure of 8 mmHg, 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.The present study is designed to confirm the reported benefits for postoperative pain and provide additional data needed to address questions regarding the effects of this intervention on operating theatre 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.