Clinical trial NCT06862947: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Laparoscopy
Postoperative Pain
Rectus Sheath Block
Keywords: Gynecology
Single-Port Laparoscopy
Rectus Sheath Block
Postop Pain Management
Lead sponsor: Chengdu Jinjiang Maternity and Child Health Hospital
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain Control
timeFrame: 48 hours post-surgery
Secondary outcomes:
measure: Intraoperative Opioid Consumption
timeFrame: Intraoperative
measure: Postoperative Recovery Parameters
timeFrame: 24 hours post-surgery
measure: Postoperative Recovery Parameters
timeFrame: 48 hours post-surgery
measure: Postoperative Recovery Parameters
timeFrame: From postoperative to discharge
measure: Adverse Event Rates
timeFrame: 48 hours post-surgery
measure: Adverse Event Rates
timeFrame: 48 hours post-surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu Jinjiang District Women & Children Health Hospital
state: Sichuan
Study officials:
affiliation: Chengdu Jinjiang District Women & Children Health Hospital
name: Fei Jia, BS
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.