Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy (RSB)

March 3, 2025 updated by: Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Jinjiang District Women & Children Health Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound-Guided Rectus Sheath Block
Participants receive bilateral rectus sheath block with 15 ml of 0.4% ropivacaine on each side under ultrasound guidance
Procedure: Rectus Sheath Block
Bilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side
Placebo Comparator: Placebo
articipants receive an equal volume of 0.9% saline as a placebo
Procedure: Placebo
Injection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
48 hours post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Opioid Consumption
Time Frame: Intraoperative
Total opioid consumption (sufentanil and remifentanil) during the intraoperative period.
Intraoperative
Postoperative Recovery Parameters
Time Frame: 24 hours post-surgery
Time to mobilization,
24 hours post-surgery
Postoperative Recovery Parameters
Time Frame: 48 hours post-surgery
Time to first passage of flatus
48 hours post-surgery
Postoperative Recovery Parameters
Time Frame: From postoperative to discharge
Length of hospital stay
From postoperative to discharge
Adverse Event Rates
Time Frame: 48 hours post-surgery
Incidence of postoperative nausea and vomiting (PONV)
48 hours post-surgery
Adverse Event Rates
Time Frame: 48 hours post-surgery
Incidence of dizziness
48 hours post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Jinjiang Maternity and Child Health Hospital

Investigators

  • Study Chair: Fei Jia, BS, Chengdu Jinjiang District Women & Children Health Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2022

Primary Completion (Actual)

April 22, 2023

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 3, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202214

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

For our study "Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy," we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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