4-Point TAP Block vs. Combined RSB-OSTAP Block for Recovery After Laparoscopic Cholecystectomy

NCT07264608 | Not Yet Recruiting

• 1 other identifier: 4TAB-RSB
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy is a common keyhole surgery to remove the gallbladder. Although the cuts are small, patients can still have significant pain and nausea after the operation, which may delay recovery and discharge. To improve comfort, doctors often use ultrasound-guided abdominal nerve blocks as part of multimodal pain management. In this single-center, randomized controlled trial, adult patients scheduled for elective laparoscopic cholecystectomy will receive standard general anesthesia and be randomly assigned to one of two routinely used block techniques at the end of surgery: (1) a 4-point transversus abdominis plane (TAP) block, or (2) a combined bilateral rectus sheath block plus oblique subcostal TAP block. Both techniques are performed under ultrasound guidance while the patient is still asleep. The main aim of the study is to compare the quality of recovery on the first day after surgery between the two groups, using a short questionnaire (QoR-15). Secondary aims are to compare pain scores, the need for additional pain medicine, and the frequency of postoperative nausea and vomiting between the groups during the first 24 hours. All other aspects of anesthesia and surgical care will follow standard hospital practice. Participation is not expected to add significant risk beyond that of routine anesthesia and surgery, as both block techniques are already commonly used in clinical practice.

Conditions

Quality of Recovery; Postoperative Pain

Keywords

Quality of recovery; TAP block; Rectus sheath block; OSTAP block; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery score (QoR-15)

  The Quality of Recovery-15 (QoR-15) questionnaire will be used to assess postoperative recovery quality at 24 hours after surgery. The QoR-15 scale ranges from 0 to 150 points, with higher scores indicating better recovery quality.

  24 hours

Secondary Outcomes (3)

• Postoperative pain score (VAS)

  30 minutes, 2 hours, 8 hours, and 24 hours after surgery.

• Incidence of postoperative nausea and vomiting (PONV)

  First 24 hours postoperative.

• Antiemetic requirement

  First 24 hours postoperative.

Study Arms (2)

4-Point TAP (4QTAP) Group

EXPERIMENTAL

An ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral anatomical sites. A total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point

Procedure: 4-Point TAP (4QTAP) Group

RSB + OSTAP Group

ACTIVE COMPARATOR

A combined bilateral rectus sheath block and bilateral oblique subcostal TAP block will be performed under ultrasound guidance. Four injection points (two RSB + two OSTAP) will be used, and a total of 40 mL of 0.25% bupivacaine will be administered, with 10 mL injected at each point.

Procedure: RSB + OSTAP Group

Interventions

4-Point TAP (4QTAP) Group PROCEDURE

4-Point TAP (4QTAP) Group: Ultrasound-guided 4-point transversus abdominis plane block will be performed at two subcostal and two lateral injection points. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).

4-Point TAP (4QTAP) Group

RSB + OSTAP Group PROCEDURE

RSB + OSTAP Group: Ultrasound-guided bilateral rectus sheath block (two injection points) combined with bilateral oblique subcostal TAP block (two injection points) will be performed. A total of 40 mL of 0.25% bupivacaine will be administered (10 mL at each point).

RSB + OSTAP Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years
• ASA physical status I-II
• Scheduled for elective laparoscopic cholecystectomy
• Ability to understand the study and provide written informed consent

You may not qualify if:

• Allergy or hypersensitivity to local anesthetics or study medications
• Coagulopathy, anticoagulant therapy, or local infection at block site
• Severe pulmonary disease (severe COPD, uncontrolled asthma, respiratory failure)
• NYHA class III-IV heart failure
• History of thoracic or abdominal surgery affecting block area
• Chronic pain syndrome or regular opioid/analgesic use
• Morbid obesity (BMI \> 35 kg/m²)
• Pregnancy or breastfeeding
• Cognitive impairment preventing cooperation
• Conversion to open cholecystectomy

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

Konya City Hospital

Konya, Konya, 420120, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Population Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Officials

• Esma karaarslan, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Esma karaarslan, MD

CONTACT

+905057317061; esmaayvaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (MD), Department of Anesthesiology and Reanimation, Konya City Hospital

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 30, 2025
• Primary Completion: April 15, 2026
• Study Completion: April 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)