NCT06862947

Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy

Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy: A Prospective Randomized Double-Blind Placebo-Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Chengdu Jinjiang Maternity and Child Health Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Title: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy Brief Summary: This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. The study is a prospective, randomized, double-blind, placebo-controlled trial involving 90 patients aged 18 to 65 years, with ASA I or II physical status, scheduled for single-port laparoscopic surgery lasting less than 2 hours. Participants are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at multiple time points. Secondary outcomes include opioid consumption, effective activations of the analgesia pump, and postoperative recovery parameters such as time to mobilization and length of hospital stay. The study hypothesizes that preoperative ultrasound-guided bilateral RSB will significantly improve postoperative

Detailed description

Background: Gynecological single-port laparoscopy has become a preferred surgical approach due to its minimal trauma, concealed scarring, and rapid postoperative recovery. However, postoperative pain and slow recovery of gastrointestinal function remain challenges. Traditional analgesic protocols often rely on opioids, which can cause adverse effects such as nausea, vomiting, bowel paralysis, and respiratory depression. Objective: This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. Methods: This is a prospective, randomized, double-blind, placebo-controlled trial. Participants are 90 patients aged 18 to 65 years, ASA I or II, scheduled for single-port laparoscopic surgery lasting less than 2 hours. They are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline. Interventions: RSB Group: Bilateral RSB with 15 ml of 0.4% ropivacaine on each side. Placebo Group: Bilateral injection of 15 ml of 0.9% saline. Outcome Measures: Primary Outcome: Postoperative pain assessed using the Visual Analog Scale (VAS) at 30 minutes, 6 hours, 12 hours, and 24 hours postoperatively. Secondary Outcomes: Opioid consumption, effective activations of the analgesia pump, time to mobilization, time to first passage of flatus, and length of hospital stay. Hypothesis: Preoperative ultrasound-guided bilateral RSB will significantly improve postoperative analgesia, reduce opioid consumption, and accelerate postoperative recovery. Ethics Approval: The study received approval from the Ethics Committee of Chengdu Jinjiang District Women \& Children Health Hospital (approval number: 202214). Funding: This study was supported by the Chengdu Medical Research Project (No. 2023465) and the Chengdu Medical Research Project (No. 2022548).

Conditions

• Gynecological Laparoscopy
• Postoperative Pain
• Rectus Sheath Block

Interventions

Type	Name	Description
PROCEDURE	Rectus Sheath Block	Bilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side
PROCEDURE	Placebo	Injection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group.

Timeline

• Start date: 2022-04-26
• Primary completion: 2023-04-22
• Completion: 2024-10-01
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: China