M-TAPA vs RSB in Midline Abdominal Incision Laparotomy

NCT ID: NCT07233629

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-02-01

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.

Detailed Description

Patients were divided into two randomized groups: Group 1 (S-TAP group, n=30) and Group 2 (RSB group, n=30). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After the surgery waqs completed, patients in Group 1 will receive modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Patients in Group 2 will receive rectus sheath block (RSB) with 20 mL of 0.25% bupivacaine bilaterally (with a total volume of 40 mL). Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.

Conditions

Postoperative Pain; Laparotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

M-TAPA

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

20 mL of 0.25% bupivacaine on each side

RSB

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.

Group Type: ACTIVE_COMPARATOR

Rectus Sheath Block

Intervention Type: PROCEDURE

20 mL of 0.25% bupivacaine on each side

Interventions

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

20 mL of 0.25% bupivacaine on each side

Intervention Type: PROCEDURE

Rectus Sheath Block

20 mL of 0.25% bupivacaine on each side

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Oguz Gundogdu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oğuz Gündoğdu

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Locations

Sivas Cumhuriyet University

Sivas, Sivas, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023-03/02

Identifier Type: -

Identifier Source: org_study_id