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

NCT06862947 | Completed

• 1 other identifier: 202214
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecological Laparoscopy; Postoperative Pain; Rectus Sheath Block

Keywords

Gynecology; Single-Port Laparoscopy; Rectus Sheath Block; Postop Pain Management

Outcome Measures

Primary Outcomes (1)

• 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).

  48 hours post-surgery

Secondary Outcomes (6)

• Intraoperative Opioid Consumption

  Intraoperative

• Postoperative Recovery Parameters

  24 hours post-surgery

• Postoperative Recovery Parameters

  48 hours post-surgery

• Postoperative Recovery Parameters

  From postoperative to discharge

• Adverse Event Rates

  48 hours post-surgery

Study Arms (2)

Ultrasound-Guided Rectus Sheath Block

ACTIVE COMPARATOR

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

Procedure: Rectus Sheath Block

Placebo

PLACEBO COMPARATOR

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

Procedure: Placebo

Interventions

Rectus Sheath Block PROCEDURE

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

Ultrasound-Guided Rectus Sheath Block

Placebo PROCEDURE

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: This study is exclusively open to adult females. The study focuses on gynecological single-port laparoscopic procedures, which are medical interventions typically applicable only to women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Jinjiang Maternity and Child Health Hospital: lead

Study Sites (1)

Chengdu Jinjiang District Women & Children Health Hospital

Chengdu, Sichuan, China

Location

Related Publications (6)

• Zhang Y, Zhu Y. Comparison of conventional versus single port laparoscopy for surgical treatment of gynecological diseases: a pilot study. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):252-260. doi: 10.5114/wiitm.2021.105823. Epub 2021 May 5.

  PMID: 35251414 BACKGROUND

• Wang J, Xu X, Xu J. Application of single-port procedure and ERAS management in the laparoscopic myomectomy. BMC Womens Health. 2023 Aug 1;23(1):401. doi: 10.1186/s12905-023-02550-6.

  PMID: 37528370 BACKGROUND

• Xu M, Feng Y, Song X, Fu S, Lu X, Lai J, Lu Y, Wang X, Lai R. Combined Ultrasound-Guided Thoracic Paravertebral Nerve Block with Subcostal Transversus Abdominis Plane Block for Analgesia After Total Minimally Invasive Mckeown Esophagectomy: A Randomized, Controlled, and Prospective Study. Pain Ther. 2023 Apr;12(2):475-489. doi: 10.1007/s40122-023-00474-5. Epub 2023 Jan 17.

  PMID: 36648745 BACKGROUND

• Liang M, Xv X, Ren C, Yao Y, Gao X. Effect of ultrasound-guided transversus abdominis plane block with rectus sheath block on patients undergoing laparoscopy-assisted radical resection of rectal cancer: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2021 Mar 24;21(1):89. doi: 10.1186/s12871-021-01295-9.

  PMID: 33761901 BACKGROUND

• Chung W, Yoon Y, Kim JW, Kwon SI, Yang JB, Lee KH, Yoo HJ. Comparing two different techniques of rectus sheath block after single port laparoscopic surgery in benign adnexal mass patients: Surgical versus ultrasonography guidance-A randomized, single-blind, case-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:29-33. doi: 10.1016/j.ejogrb.2017.08.020. Epub 2017 Aug 18.

  PMID: 28843866 BACKGROUND

• Mugita M, Kawahara R, Tamai Y, Yamasaki K, Okuno S, Hanada R, Inaoka M, Funato T. Effectiveness of ultrasound-guided transversus abdominis plane block and rectus sheath block in pain control and recovery after gynecological transumbilical single-incision laparoscopic surgery. Clin Exp Obstet Gynecol. 2014;41(6):627-32.

  PMID: 25551952 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fei Jia, BS

  Chengdu Jinjiang District Women & Children Health Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 6, 2025
• Study Start: April 26, 2022
• Primary Completion: April 22, 2023
• Study Completion: October 1, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)