Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Cancer; Abdomen Disease
• Intervention / Treatment: Other: M-Tapa Block

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Marmara University Pendik Research and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: M-Tapa + IV PCA applied group; 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; M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery
Other: IV PCA applied group; 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; M-TAPA block was performed bilaterally with 20 mL of 0.2% bupivacaine under ultrasound guidance at the end of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	The postoperative opioid consumption	Postoperative 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Marmara University
• Investigators: Study Chair: GAMZE ÇABAKLI, Marmara Univercity

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 25, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: postoperative analgesia; major abdominal surgery; opioid consumption; M-TAPA
• Other Study ID Numbers: 03.03.2023/371

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No