- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07440940
Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy
Effect of Timing of Ultrasound-Guided Subcostal Transversus Abdominis Plane Block Combined With Rectus Sheath Block on Postoperative Pain in Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain after laparoscopic cholecystectomy remains a significant clinical concern despite the minimally invasive nature of the procedure. Ultrasound-guided abdominal wall blocks, including subcostal transversus abdominis plane (TAP) block and rectus sheath block (RSB), are widely used to reduce postoperative pain and opioid requirements. However, the optimal timing of block administration relative to surgical incision remains unclear.
This prospective, single-center, randomized controlled trial will compare the analgesic efficacy of pre-incisional versus post-operative administration of combined ultrasound-guided subcostal TAP block and RSB in adult patients undergoing elective laparoscopic cholecystectomy under general anesthesia.
Participants will be randomized in a 1:1 ratio using block randomization with randomly permuted block sizes. Standardized general anesthesia and postoperative analgesia protocols will be applied to all participants.
The primary outcome will be postoperative pain intensity measured using a numerical rating scale at predefined time points after surgery. Secondary outcomes will include cumulative opioid consumption, incidence of postoperative nausea and vomiting, rescue analgesic requirements, and recovery profiles.
The findings of this study are expected to provide evidence for optimizing the timing of abdominal wall block administration to improve postoperative analgesia and patient recovery after laparoscopic cholecystectomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hye-yeon Cho, MD
- Phone Number: +82-2-970-8705
- Email: anesthesia_chy@eulji.ac.kr
Study Contact Backup
- Name: Soojeong Kang, MD
- Phone Number: +82-2-970-8705
- Email: 20260034@eulji.ac.kr
Study Locations
-
-
-
Seoul, South Korea, 01830
- Recruiting
- Nowon Eulji University Hospital
-
Contact:
- Hye-yeon Cho, MD
- Phone Number: +82-2-970-8705
- Email: anesthesia_chy@eulji.ac.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre-incisional Block Group
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.
|
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.
|
|
Experimental: Postoperative Block Group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum postoperative pain intensity within 24 hours
Time Frame: Within 24 hours after surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum postoperative pain intensity during post-anesthesia care unit stay
Time Frame: During the post-anesthesia care unit stay
|
The highest postoperative pain intensity measured using an 11-point numeric rating scale (NRS; 0 = no pain, 10 = worst pain imaginable) during the recovery period.
|
During the post-anesthesia care unit stay
|
|
Cumulative rescue opioid consumption within 24 hours
Time Frame: Within 24 hours after surgery
|
Total amount of rescue opioid administered between 1 and 24 hours after surgery.
|
Within 24 hours after surgery
|
|
Incidence of postoperative nausea and vomiting
Time Frame: Within 24 hours after surgery
|
Occurrence of nausea or vomiting during the postoperative period.
|
Within 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hye-yeon Cho, Nowon Eulji University Hospital, Eulji University College of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-01-026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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