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Clinical Trials/NCT06384677
NCT06384677CompletedNot Applicable

Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

Marmara University1 site in 1 country43 target enrollmentStarted: April 20, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
43
Locations
1
Primary Endpoint
Opioid Consumption

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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. .

Intervention: M-Tapa Block (Other)

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.

Intervention: M-Tapa Block (Other)

Outcomes

Primary Outcomes

Opioid Consumption

Time Frame: Postoperative 24 hours

The postoperative opioid consumption

Secondary Outcomes

  • the need for rescue analgesia(postoperative 24 hours)
  • side effects(postoperative 24 hours)
  • NRS Scores(postoperative 24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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