USG-Guided TAPA vs RIFB Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

NCT07552701 | Recruiting

• 1 other identifier: 2025-151
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy (LC) can cause moderate-to-severe postoperative pain from visceral, referred shoulder, and incisional sources. Multimodal analgesia is recommended, but opioids carry significant side effects. Ultrasound-guided interfascial plane blocks offer a safe alternative. The Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) blocks T5-T12 dermatomes, while the Recto-Intercostal Fascial Plane Block (RIFPB) provides sensory blockade across the upper anterolateral abdomen. This study compares the postoperative analgesic efficacy of bilateral M-TAPA versus bilateral RIFPB in patients undergoing LC.

Conditions

Postoperative Pain; Acute Cholecystitis; Cholelithiasis; Postoperative Nausea and Vomiting

Keywords

Laparoscopic Cholecystectomy; Transversus abdominis Plane Block; Rectus-intercostalis facial plane block

Outcome Measures

Primary Outcomes (1)

• Postoperative Opioid Consumption

  Total tramadol consumption (mg) via patient-controlled analgesia (PCA) recorded at 0-1, 1-12, 12-24 hours, and total 24 hours postoperatively.

  24 hours postoperatively

Study Arms (2)

M-TAPA Group

ACTIVE COMPARATOR

M-TAPA Group: Patients receiving ultrasound-guided bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) using 20 ml of 0.25% bupivacaine per side, applied at the 10th rib level beneath the costochondral perichondrium after surgery while under anesthesia.

Procedure: M-TAPA Group

RIFPB Group

ACTIVE COMPARATOR

RIFPB Group: Patients receiving ultrasound-guided bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 ml of 0.25% bupivacaine per side, injected into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages just below the xiphoid process, applied after surgery while under anesthesia.

Procedure: RIFPB Group

Interventions

M-TAPA Group PROCEDURE

Patients receiving ultrasound-guided bilateral Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) using 20 ml of 0.25% bupivacaine per side, applied at the 10th rib level beneath the costochondral perichondrium after surgery while under anesthesia.

M-TAPA Group

RIFPB Group PROCEDURE

Patients receiving ultrasound-guided bilateral Recto-Intercostal Fascial Plane Block (RIFPB) using 20 ml of 0.25% bupivacaine per side, injected into the interfascial plane between the rectus abdominis muscle and the 6th-7th costal cartilages just below the xiphoid process, applied after surgery while under anesthesia.

RIFPB 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:

• Age 18-65 years
• ASA physical classification I-II
• BMI \< 35 kg/m²
• Scheduled for elective laparoscopic cholecystectomy due to cholelithiasis
• Able to use and understand the NRS pain scoring system
• Able to use and understand the QoR-15 scale
• Able to communicate in Turkish
• Provided written informed consent

You may not qualify if:

• Refusal to participate in the study
• BMI \> 35 kg/m²
• ASA physical classification III-V
• Age \< 18 or \> 65 years
• Allergy to local anesthetics or study analgesics
• Pregnancy or breastfeeding
• Inability to use or understand the NRS pain scoring system or QoR-15 scale
• Inability to communicate in Turkish
• Uncontrolled anxiety disorder
• Alcohol or drug dependency
• Neuromuscular or peripheral nerve disease
• High-dose opioid use within 3 days prior to surgery
• Widespread chronic pain
• Diabetes mellitus
• Hepatic or renal insufficiency

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University

Çorum, 19100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Cholecystitis, Acute; Cholelithiasis; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Guvenc Dogan, MD

  Hitit University

  STUDY CHAIR

Central Study Contacts

Hakan Akel, MD

CONTACT

+905442094827; drhakanakel@gmail.com

Alperen KISA, MD

CONTACT

+905072322428; alperenkisa@hotmail.com.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients undergoing laparoscopic cholecystectomy are randomly assigned to two parallel groups: Group M (bilateral M-TAPA) and Group R (bilateral RIFPB), to compare postoperative analgesic efficacy.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 27, 2026
• Study Start: March 16, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TU (1)