NCT07440940

Brief Summary

This prospective randomized controlled trial aims to evaluate whether the timing of ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) affects postoperative pain in patients undergoing laparoscopic cholecystectomy. Participants will be randomly assigned to receive the combined regional blocks either before surgical incision or after completion of surgery. The primary outcome is postoperative pain intensity measured using a numerical rating scale. Secondary outcomes include opioid consumption, incidence of postoperative nausea and vomiting, and other recovery parameters. The results of this study may help optimize the timing of abdominal wall blocks to improve postoperative analgesia and recovery following laparoscopic cholecystectomy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
7mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

February 22, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

February 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2027

Last Updated

February 27, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

February 22, 2026

Last Update Submit

February 25, 2026

Conditions

Keywords

Laparoscopic CholecystectomyTransversus Abdominis Plane BlockRectus Sheath BlockPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Maximum postoperative pain intensity within 24 hours

    The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the first 24 hours after surgery, assessed at 1, 6, 12, and 24 hours postoperatively.

    Within 24 hours after surgery

Secondary Outcomes (3)

  • Maximum postoperative pain intensity during post-anesthesia care unit stay

    During the post-anesthesia care unit stay

  • Cumulative rescue opioid consumption within 24 hours

    Within 24 hours after surgery

  • Incidence of postoperative nausea and vomiting

    Within 24 hours after surgery

Study Arms (2)

Pre-incisional Block Group

EXPERIMENTAL

Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after induction of general anesthesia and before surgical incision.

Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath block

Postoperative Block Group

EXPERIMENTAL

Participants receive ultrasound-guided subcostal transversus abdominis plane (TAP) block combined with rectus sheath block (RSB) after completion of surgery and before emergence from anesthesia.

Procedure: Ultrasound-guided subcostal TAP block combined with rectus sheath block

Interventions

Ultrasound-guided right subcostal transversus abdominis plane (TAP) block combined with bilateral rectus sheath block (RSB) is performed under sterile conditions using local anesthetic for postoperative analgesia.

Postoperative Block GroupPre-incisional Block Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective laparoscopic cholecystectomy
  • Adults aged 18 to 80 years
  • Ability to understand the study procedures and provide informed consent
  • American Society of Anesthesiologists (ASA) physical status I-III

You may not qualify if:

  • Presence of significant pain unrelated to the target disease that may interfere with pain assessment
  • Known allergy or contraindication to study medications (ropivacaine, acetaminophen, nefopam, or pethidine)
  • Planned single-port laparoscopic cholecystectomy
  • American Society of Anesthesiologists (ASA) physical status IV or higher
  • Infection of the abdominal wall or skin at the injection site, or anatomical abnormalities of the abdominal wall
  • Major neurological, psychiatric, or systemic diseases that may affect pain perception, treatment response, or study evaluation
  • Requirement for postoperative mechanical ventilation
  • Pregnancy or breastfeeding
  • Considered unsuitable for the study by the investigator
  • Refusal to participate or inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nowon Eulji University Hospital

Seoul, 01830, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Hye-yeon Cho

    Nowon Eulji University Hospital, Eulji University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants and outcome assessors will be blinded to group allocation. The anesthesiologist performing the block will not be blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to receive the combined ultrasound-guided subcostal TAP block and rectus sheath block either before surgical incision or after completion of surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 22, 2026

First Posted

February 27, 2026

Study Start

February 23, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 15, 2027

Last Updated

February 27, 2026

Record last verified: 2026-02

Locations