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NCT Number: NCT06862947

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chengdu Jinjiang District Women & Children Health Hospital

Chengdu, Sichuan, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rectus sheath block

Procedure

Bilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side

Placebo

Procedure

Injection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group.

Primary outcomes

  1. 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

  1. Intraoperative Opioid Consumption

    Time frame: Intraoperative

    Total opioid consumption (sufentanil and remifentanil) during the intraoperative period.

  2. Postoperative Recovery Parameters

    Time frame: 24 hours post-surgery

    Time to mobilization,

  3. Postoperative Recovery Parameters

    Time frame: 48 hours post-surgery

    Time to first passage of flatus

  4. Postoperative Recovery Parameters

    Time frame: From postoperative to discharge

    Length of hospital stay

  5. Adverse Event Rates

    Time frame: 48 hours post-surgery

    Incidence of postoperative nausea and vomiting (PONV)

  6. Adverse Event Rates

    Time frame: 48 hours post-surgery

    Incidence of dizziness

Sponsors and collaborators

Lead sponsor

Chengdu Jinjiang Maternity and Child Health Hospital

Other

Registry information

Official study title

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

Acronym: RSB

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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