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

Comparison of 4-Point Transversus Abdominis Plane Block and Combined Bilateral Rectus Sheath-Oblique Subcostal TAP Block on Quality of Recovery After Laparoscopic Cholecystectomy: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Quality of Recovery
• Intervention / Treatment: Procedure: 4-Point TAP (4QTAP) Group; Procedure: RSB + OSTAP Group

• Study Type: Interventional
• Enrollment (Estimated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Esma karaarslan, MD; Phone Number: +905057317061; Email: esmaayvaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Konya
    • Konya, Konya, Turkey (Türkiye), 420120
      • Konya City Hospital
      • Contact: Esma karaarslan, MD; Phone Number: Esma; Email: esmaayvaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 4-Point TAP (4QTAP) Group; 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; 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).
Active Comparator: RSB + OSTAP Group; 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; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting (PONV)	Presence and severity of nausea (0-3 scale) and vomiting episodes (0-3 scale).	First 24 hours postoperative.
Antiemetic requirement	Number of patients requiring intravenous ondansetron based on nausea (≥2) or vomiting (≥1).	First 24 hours postoperative.
Postoperative pain score (VAS)	Postoperative pain intensity will be evaluated using the Visual Analog Scale (VAS) at predefined time points. The VAS scale ranges from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate worse pain.	30 minutes, 2 hours, 8 hours, and 24 hours after surgery.

Collaborators and Investigators

• Sponsor: Konya City Hospital
• Investigators: Principal Investigator: Esma Karaarslan, MD, Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Quality of recovery; TAP block; Rectus sheath block; OSTAP block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Population Characteristics; Demography; Population Groups
• Other Study ID Numbers: 4TAB-RSB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No