Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

Not Applicable

Completed

• Conditions: Abdomen Disease; Abdominal Cancer
• Interventions: Other: M-Tapa Block

• Registration Number: NCT06384677
• Lead Sponsor: Marmara University

Brief Summary

This study aims to examine the effects of M-TAPA applied for postoperative analgesia in patients who had major intraabdominal surgery on the postoperative pain score, the change in the postoperative total opioid requirement and the side effects.

Detailed Description

The investigators seperated the patients into two groups as M-TAPA applied group and control group.In group M-TAPA, M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery. No block was performed in the control group. The participants were administered morphine through patient controlled analgesia (PCA) pump with a bolus dose of 1 mg, 15 min lockout interval. The postoperative pain scores (the numeric rating scores (NRS)), total opiod consumption in the first 48 h, and opioid related side effects were recorded.

Study Timeline

• Study Start: 2023-04-20
• Primary Completion: 2024-02-01
• Study Completion: 2024-02-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-25
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• patient > 17 years old
• ASA score 1-3
• undergoing major intra-abdominal surgery

Exclusion Criteria

• ASA IV patients
• patients with known neurological or psychiatric disorders
• patients with clinically significant cardiovascular, respiratory, hepatic, renal or metabolic disease
• patients with long-term drug (opioid) or alcohol dependence
• patients with BMI>30
• patients with intellectual disability
• patients who developed massive bleeding and coagulopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV PCA applied group	M-Tapa Block	In the IV PCA group, the surgeon performed local infiltration with 40 mL of 0.25% bupivacaine around the incisions. All patients were provided postoperative analgesia with intravenous patient-controlled analgesia (IVHKA). When pain was expressed by the patient, the patient pressed a button and the IV HKA pump was programmed to deliver a 1 ml bolus dose with a 10-minute lockout interval and no background infusion allowed. Each 1 ml of IVHKA solution contains 1 mg of morphine.
M-Tapa + IV PCA applied group	M-Tapa Block	After appropriate skin disinfection, the transversus abdominis, internal oblique and external oblique muscles were determined with a high-frequency linear probe (Esaote) at the costochondral angle in the sagittal plane under ultrasound guidance at the 10th costal border. A 21-G, 80-mm peripheral block needle was placed in the cranial direction using the in-plane technique, the needle tip did not exceed the cranial edge of the 10th costal cartilage, and 20 ml of 0.25% bupivacaine was applied to the lower surface of the chondrium on both sides, right and left. .

Primary Outcome Measures

Name	Time	Method
Opioid Consumption	Postoperative 24 hours	The postoperative opioid consumption

Secondary Outcome Measures

Name	Time	Method
the need for rescue analgesia	postoperative 24 hours	if NRS\>4: apply rescue analgesia: the total count of rescue analgesia need
side effects	postoperative 24 hours	nausea- vomiting
NRS Scores	postoperative 24 hours	Numeric Rating Scale score (rating from 1 to 10. 1:no pain to 10: worst pain ever)

Trial Locations

Locations (1)

Marmara University Pendik Research and Training Hospital; 🇹🇷 Istanbul, Turkey