Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

NCT06384677 | Completed

• 1 other identifier: 03.03.2023/371
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Abdominal Cancer; Abdomen Disease

Keywords

major abdominal surgery; M-TAPA; opioid consumption; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  The postoperative opioid consumption

  Postoperative 24 hours

Secondary Outcomes (3)

• NRS Scores

  postoperative 24 hours

• the need for rescue analgesia

  postoperative 24 hours

• side effects

  postoperative 24 hours

Study Arms (2)

M-Tapa + IV PCA applied group

OTHER

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. .

Other: M-Tapa Block

IV PCA applied group

OTHER

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.

Other: M-Tapa Block

Interventions

M-Tapa Block OTHER

M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery

IV PCA applied group; M-Tapa + IV PCA applied group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Pendik Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Hoyme U, Baumueller A, Madsen PO. Antibiotics excretion in canine vaginal and urethral secretions. Invest Urol. 1978 Jul;16(1):35-8.

  PMID: 29017 BACKGROUND

Study Officials

• GAMZE ÇABAKLI

  Marmara Univercity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 25, 2024
• Study Start: April 20, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)