Comparison of Postoperative Analgesia Methods in Patients Undergoing Major Intraabdominal Surgery

NCT ID: NCT06384677

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-20

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Abdominal Cancer Abdomen Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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. .

Group Type OTHER

M-Tapa Block

Intervention Type 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

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.

Group Type OTHER

M-Tapa Block

Intervention Type OTHER

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

Interventions

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M-Tapa Block

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GAMZE ÇABAKLI

Role: STUDY_CHAIR

Marmara Univercity

Locations

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Marmara University Pendik Research and Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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

Reference Type BACKGROUND
PMID: 29017 (View on PubMed)

Other Identifiers

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03.03.2023/371

Identifier Type: -

Identifier Source: org_study_id

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