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Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) In Laparoscopic Cholecystectomy

ConditionsLaparoscopic CholecystectomyPeripheral Nerve Block
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUdayana University

About this trial

The Goal of this clinical trial is to determine the advantages of using Peripheral Nerve Block by injecting drugs under the skin on both sides of the abdomen in the upper abdominal area in patients undergoing laparoscopic Cholecystectomy. Study participants will be divided into 2 groups, namely group P1 receiving Modified Thoracoabdominal Perichondrial Approach (M-TAPA) block anesthesia after laparoscopic cholecystectomy and group P2 only receiving intravenous opioids postoperatively. Peripheral nerve blocks on both sides of the upper abdomen are expected to be able to prolong the duration of pain relief, reduce the pain scale, and the total dose of pain medication needed postoperatively. The injection of this peripheral nerve block drug will be carried out by an anesthesiologist. Researchers will continue to anticipate the occurrence of side effects that can occur with strict monitoring and emergency care standards. This study will last up to 24 hours after surgery.

The main question it aims to answer is:

To prove that the amount of postoperative intravenous opioid consumption with M-TAPA block is lower than the control group.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patient 18-65 yeasr old

IMT 17.5-30 kg/m2

Patient with ASA I-II

Disqualifiers

Patient Refusal

Local Infection

Chronic Analgesia drug user

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA

    Procedure/Surgery

    USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.

  • Opioid Intravena

    Device

    Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA)Experimental treatment 1 intervention
Group B: Opioid IntravenaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Proving the effectiveness of postoperative analgesia with Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) in laparoscopic cholecystectomy patients at Prof. I.G.N.G. Ngoerah General Hospital.

Evaluate total PCA Intravena opioid consumption (morphin in mg) delivered dose.

Time frame
24 hours

Secondary outcomes

1

Numeric rating Scale

Evaluate Pain Scale using Numeric Rating Scale (NRS) rest and movement 0,2, 12, 24 hours for operative. Range 0-10, 0 is no pain, 10 is severe pain

Time frame
24 hours
2

QoR 40

Collect completed questionnaires QoR40 by participant. The score range from 40(Extremely poor quality) to 200 (excellent quality)

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Udayana University

Lead sponsor

Source ClinicalTrials.gov
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