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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-26

Study Completion Date

2024-10-01

Brief Summary

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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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Detailed Description

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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

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Gynecological Laparoscopy Postoperative Pain Rectus Sheath Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Ultrasound-Guided Rectus Sheath Block

Participants receive bilateral rectus sheath block with 15 ml of 0.4% ropivacaine on each side under ultrasound guidance

Group Type ACTIVE_COMPARATOR

Rectus Sheath Block

Intervention Type PROCEDURE

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

Placebo

articipants receive an equal volume of 0.9% saline as a placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

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

Interventions

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Rectus Sheath Block

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

Intervention Type PROCEDURE

Placebo

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No