M-TAPA vs RSB in Midline Abdominal Incision Laparotomy

N/AActive Not RecruitingNCT07233629

Cumhuriyet University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Pain Laparotomy

Interventions

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

20 mL of 0.25% bupivacaine on each side

Rectus Sheath BlockPROCEDURE

20 mL of 0.25% bupivacaine on each side

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Sivas Cumhuriyet University

Sivas, Sivas, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: Postoperative 24 hours

Total tramadol consumption

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

Time frame: Postoperative 24 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.