Comparison of Ultrasound-Guided Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia After Laparoscopic Cholecystectomy: A Randomized Controlled Study

NCT07751770 | Completed

• 2 other identifiers: MTAPA-ESP2024-KAEK-18
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study compared two ultrasound-guided regional anesthesia techniques for pain relief after laparoscopic gallbladder surgery: the modified thoracoabdominal nerve block through a perichondrial approach and the erector spinae plane block. Adults undergoing elective laparoscopic cholecystectomy under general anesthesia were randomly assigned to receive one of these two nerve blocks on both sides of the body before awakening from anesthesia. Both techniques used bupivacaine as the local anesthetic. After surgery, pain intensity, tramadol consumption, need for additional pain medication, nausea and vomiting, antiemetic use, and block-related complications were assessed during the first 24 postoperative hours. The main objective was to determine whether the two techniques differed in their ability to reduce postoperative tramadol consumption and provide effective pain relief.

Conditions

Postoperative Pain; Laparoscopic Cholecystectomy

Keywords

Postoperative Analgesia; Modified Thoracoabdominal Nerve Block Through Perichondrial Approach; M-TAPA Block; Erector Spinae Plane Block; Ultrasound-Guided Regional Anesthesia; Tramadol Consumption; Acute Postoperative Pain; Patient-Controlled Analgesia

Outcome Measures

Primary Outcomes (1)

• Cumulative Postoperative Tramadol Consumption During the First 24 Hours

  The total amount of tramadol delivered through intravenous patient-controlled analgesia was calculated for each participant. The patient-controlled analgesia device was programmed to deliver a 15 mg tramadol bolus with a 15-minute lockout interval. Tramadol consumption recorded during the postoperative observation periods was summed and reported in milligrams. The standardized intraoperative tramadol dose administered to all participants was not included in this outcome.

  From arrival in the post-anesthesia care unit through 24 hours after surgery

Secondary Outcomes (7)

• Postoperative Pain Intensity Assessed Using the Visual Analog Scale

  At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery

• Patient-Controlled Analgesia Demand Count

  At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery

• Tramadol Consumption at Individual Postoperative Assessment Times

  At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery

• Requirement for Additional Postoperative Analgesia

  From post-anesthesia care unit arrival through 24 hours after surgery

• Postoperative Nausea and Vomiting Score

  At post-anesthesia care unit arrival and 30 minutes, 2 hours, 3 hours, 6 hours, and 24 hours after surgery

Study Arms (2)

Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach

EXPERIMENTAL

After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach. The block was performed at the inferior surface of the 10th costal cartilage using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms.

Procedure: Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach

Bilateral Erector Spinae Plane Block

ACTIVE COMPARATOR

After removal of the gallbladder and before extubation, participants received a bilateral ultrasound-guided erector spinae plane block at the T7 vertebral level. The local anesthetic was injected between the erector spinae muscle and the transverse process using 0.25% bupivacaine. Participants also received the standardized general anesthesia and multimodal postoperative analgesia protocols used in both study arms.

Procedure: Bilateral Ultrasound-Guided Erector Spinae Plane Block

Interventions

Bilateral Ultrasound-Guided Modified Thoracoabdominal Nerve Block Through Perichondrial Approach PROCEDURE

After removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance. The external oblique, internal oblique, and transversus abdominis muscles were identified at the inferior margin of the 10th costal cartilage. A block needle was advanced using an in-plane technique toward the inferior surface of the costal cartilage. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side.

Bilateral Modified Thoracoabdominal Nerve Block Through Perichondrial Approach

Bilateral Ultrasound-Guided Erector Spinae Plane Block PROCEDURE

After removal of the gallbladder and before extubation, the block was performed bilaterally under ultrasound guidance at the T7 vertebral level. The needle was advanced using an in-plane technique until its tip was positioned between the erector spinae muscle and the transverse process. After confirmation of the needle position with 2 to 3 mL of normal saline, 20 mL of 0.25% bupivacaine was administered on each side.

Bilateral Erector Spinae Plane Block

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 between 18 and 65 years
• Scheduled to undergo elective laparoscopic cholecystectomy under general anesthesia
• American Society of Anesthesiologists physical status I to III
• Body mass index below 35 kg/m²
• International Normalized Ratio and platelet count within the institutional reference ranges
• Liver and renal function test results within the institutional reference ranges
• Provision of written informed consent

You may not qualify if:

• Bleeding diathesis
• Known allergy to local anesthetics
• Infection or inflammation at the planned block application site
• Gallbladder perforation
• Known neurological disease
• American Society of Anesthesiologists physical status IV or higher
• Long-term medication use for chronic pain
• Advanced liver or renal failure
• Previous abdominal surgery or abdominal trauma
• Use of any opioid medication within 24 hours before surgery
• Pregnancy
• Refusal to participate
• Intraoperative conversion from laparoscopic to open surgery

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Istanbul Provincial Directorate of Health Sultan 2.Abdul Hamid Khan Educational and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Participants were randomly assigned in a 1:1 ratio to one of two parallel intervention groups. One group received a bilateral ultrasound-guided modified thoracoabdominal nerve block through a perichondrial approach, and the other group received a bilateral ultrasound-guided erector spinae plane block.

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 7, 2026
• Study Start: February 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 2, 2025
• Last Updated: August 7, 2026

Record last verified: 2026-08

Locations

TU (1)