M-TAPA vs RSB in Midline Abdominal Incision Laparotomy

NCT07233629 | Active Not Recruiting

• 1 other identifier: 2023-03/02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is to compare the postoperative analgesic effects of Modified ThoracoAbdominal nerve block through Perichondrial Approach (M-TAPA) versus Rectus Sheath Block (RSB) in patients undergoing laparotomy with midline abdominal incision.

Conditions

Postoperative Pain; Laparotomy

Keywords

postoperative pain; regional anesthesia; laparotomy; midline incision; rectus sheath block; modified thoracoabdominal nerve block through perichondrial approach

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale (NRS) Scores

  Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.

  Postoperative 24 hours

• Total tramadol consumption

  Postoperative total rescue analgesic need was recorded as "milligram" in unit.

  Postoperative 24 hours

Study Arms (2)

M-TAPA

ACTIVE COMPARATOR

For this group, M-TAPA blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For M-TAPA, a high frequency linear transducer USG will be placed on the chondrium in the sagittal plane at the level of the 9th-10th ribs. Then, the probe will be angled deeply to visualize the lower aspect of the costochondrium. The block needle will be inserted in-plane aiming toward the plane just below the chondrium. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.

Procedure: Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA)

RSB

ACTIVE COMPARATOR

For this group, RS blocks will be performed bilaterally right after the surgery completion with the patients in supine position. For RSB, a high frequency linear transducer USG is placed above the umbilicus transversely. The probe will then be moved laterally until the rectus abdominis muscle, its posterior sheath and the peritoneum can be visualized clearly. The block needle will be inserted in-plane from lateral to medial direction, aiming toward the posterior sheath of the rectus abdominis muscle. After negative aspiration and hidrodissection with 1-2 mL of saline and verifying the location of the needle tip, 20 mL of 0.25% bupivacaine will be administered on each side, with a total of 40 mL bilaterally.

Procedure: Rectus Sheath Block

Interventions

Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) PROCEDURE

20 mL of 0.25% bupivacaine on each side

M-TAPA

Rectus Sheath Block PROCEDURE

20 mL of 0.25% bupivacaine on each side

RSB

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients older than 18 years of age who underwent laparotomy with midline incision under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.

You may not qualify if:

• patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment
• patients who received ileostomy or colostomy

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Sivas Cumhuriyet University

Sivas, Sivas, 58140, 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 Officials

• Oğuz Gündoğdu

  Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: June 1, 2023
• Primary Completion: June 1, 2025
• Study Completion: February 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)