An interventional study of Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA and Opioid Intravena in Laparoscopic Cholecystectomy and Peripheral Nerve Block, sponsored by Udayana University. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Udayana University · Not applicable, Interventional, and Supportive care
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.
A. Treatment of patients in P1 and P2 before entering the operating room:
B. Treatment of patients in the operating room P1 and P2:
Group P1:
Group P2 No block is performed, after the operation is completed, extubation preparation is carried out immediately.
Procedures P1 and P2 after surgery:
Udayana University is the lead sponsor of 32 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.
Procedure: Modified Thorachoabdominal Nerve Block Perichondrial Approach(M-TAPA
This Group receive opioid intravena post surgery without M-TAPA Block
Device: Opioid Intravena
USG Guided Bilateral Modified Thorachoabdominal Nerve Block Perichondrial Approach (M-TAPA) using 20 ml Bupivacaine 0,25%.
Also known as: P1
Opioid Intravenous post Surgery without M-TAPA Block delivered with PCA Machine
Also known as: P2
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
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
QoR 40
Collect completed questionnaires QoR40 by participant. The score range from 40(Extremely poor quality) to 200 (excellent quality)
Time frame: 24 hours
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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