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NCT Number: NCT07440940

Timing of Subcostal TAPB Combined With Rectus Sheath Block for Postoperative Pain After Laparoscopic Cholecystectomy

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nowon Eulji University Hospital

Seoul, 01830, South Korea

Location status: Recruiting

Location contact

Hye-yeon Cho, MD

CONTACT

[email protected]

+82-2-970-8705

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound-guided subcostal TAP block combined with rectus sheath block

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Incidence of postoperative nausea and vomiting

    Time frame: Within 24 hours after surgery

    Occurrence of nausea or vomiting during the postoperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Hye-Yeon Cho, MD

CONTACT

[email protected]

+82-2-970-8705

Soojeong Kang, MD

CONTACT

[email protected]

+82-2-970-8705

Sponsors and collaborators

Lead sponsor

Eulji University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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