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
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Bilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side
Injection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group.
Chengdu Jinjiang District Women & Children Health Hospital
Chengdu, Sichuan, China
Postoperative Pain Control
ssessment of postoperative pain using the Visual Analog Scale (VAS) scores at multiple time points (30 minutes, 6 hours, 12 hours, 24 hours, and 48 hours after surgery).
Time frame: 48 hours post-surgery
Intraoperative Opioid Consumption
Total opioid consumption (sufentanil and remifentanil) during the intraoperative period.
Time frame: Intraoperative
Postoperative Recovery Parameters
Time to mobilization,
Time frame: 24 hours post-surgery
Postoperative Recovery Parameters
Time to first passage of flatus
Time frame: 48 hours post-surgery
Postoperative Recovery Parameters
Length of hospital stay
Time frame: From postoperative to discharge
Adverse Event Rates
Incidence of postoperative nausea and vomiting (PONV)
Time frame: 48 hours post-surgery
Adverse Event Rates
Incidence of dizziness
Time frame: 48 hours post-surgery
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