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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Postoperative Pain Control
Study Overview
Brief 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study was designed as a double-blind trial, ensuring that neither the patients nor the operating surgeons were aware of the group allocations throughout the study. This blinding was critical to eliminate bias in treatment administration and outcome assessment, thereby enhancing the validity of the trial results.
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients aged 18 to 65 years
- •Physical status classified as I or II according to the American Society of Anesthesiologists (ASA)
- •Surgical durations of less than 2 hours
Exclusion Criteria
- •Infection at the planned puncture site
- •Neurological disorders or nerve injuries
- •Conversion to open surgery for various reasons during the procedure
- •Coagulation abnormalities
- •Patients had the option to withdraw from the study at any time if they chose not to continue their participation.
Arms & Interventions
Ultrasound-Guided Rectus Sheath Block
Participants receive bilateral rectus sheath block with 15 ml of 0.4% ropivacaine on each side under ultrasound guidance
Intervention: Rectus Sheath Block (Procedure)
Placebo
articipants receive an equal volume of 0.9% saline as a placebo
Intervention: Placebo (Procedure)
Outcomes
Primary Outcomes
Postoperative Pain Control
Time Frame: 48 hours post-surgery
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).
Secondary Outcomes
- Adverse Event Rates(48 hours post-surgery)
- Intraoperative Opioid Consumption(Intraoperative)
- Postoperative Recovery Parameters(From postoperative to discharge)
- Postoperative Recovery Parameters(24 hours post-surgery)
- Postoperative Recovery Parameters(48 hours post-surgery)
Investigators
Fei Jia
Director of Anesthesiology Department
Chengdu Jinjiang Maternity and Child Health Hospital