Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
ID06652581

Effectiveness Of Modified-Thoracoabdominal Nerve Block Perichondrial Approach (M-TAPA) Post-Operative Analgesia Compared To Intravenous Opioids In Laparoscopic Cholecystectomy Patients

Led by Udayana University · Updated on 2024-10-22

42

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the benefits of using a Peripheral Nerve Block called the Modified Thoracoabdominal Perichondrial Approach (M-TAPA) compared to standard intravenous opioids in patients undergoing laparoscopic cholecystectomy. The goal is to see if M-TAPA can reduce pain and the need for opioid medication after surgery. The study involves adult patients aged 18 to 65 years with specific health criteria. Participants will be randomly assigned to one of two groups. One group (P1) receives the M-TAPA nerve block administered by an anesthesiologist using ultrasound guidance during surgery along with general anesthesia. The other group (P2) receives only intravenous opioids after surgery without the nerve block. Both groups undergo the same laparoscopic cholecystectomy procedure. The nerve block involves injections on both sides of the upper abdomen with the local anesthetic bupivacaine. Patients are closely monitored for side effects during and after the procedure. During the study, participants will be assessed before surgery, during anesthesia, and up to 24 hours after surgery. Pain levels are measured using a Numeric Rating Scale at multiple time points, and opioid use is tracked via a PCA infusion device. Recovery quality is also evaluated with a questionnaire before surgery and 24 hours afterward. Vital signs and side effects are monitored continuously in the recovery room. The study focuses on measuring pain relief effectiveness and opioid consumption within the first 24 hours post-operation.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged 18 to 65 years
  • Body mass index (BMI) between 17.5 and 30 kg/m2
  • Classified as American Society of Anesthesiologists (ASA) physical status I or II
Not Eligible

You will not qualify if you...

  • Patient refusal to participate
  • Presence of local infection
  • Current use of chronic analgesic drugs

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single day (surgery day)

Participants undergo laparoscopic cholecystectomy surgery with general anesthesia. The experimental group receives a modified thoracoabdominal nerve block (M-TAPA) using ultrasound guidance before surgery completion. The comparator group receives intravenous opioid analgesia post-surgery without the nerve block.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 24 hours post-surgery

Participants are observed and assessed for pain using the Numeric Rating Scale and Quality of Recovery (QoR 40) form at multiple time points after surgery, including recovery room monitoring and evaluations at 2, 12, and 24 hours postoperatively.

Multiple assessments within 24 hours post-surgery including observation in recovery room and evaluations at 2, 12, and 24 hours

Trial Site Locations

Total: 1 location

1

Prof I.G.N.G Ngoerah General Hospital

Denpasar, Bali, Indonesia, 80113

Actively Recruiting

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Research Team

A

Amelia Christiana, MD

I

Ita Indriani, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

Modified thoracoabdominal nerve block via perichondral approach: an alternative for perioperative pain management in laparoscopic cholecystectomy in a middle-income country.

Luisa Fernanda Castillo-Dávila, Carlos Jesús Torres-Anaya, Raquel Vazquez-Apodaca...

https://pubmed.ncbi.nlm.nih.gov/39217281

Comparison of Transversus Abdominis Plane Block and IV Patient-Controlled Analgesia after Lower Abdominal Surgery.

Emre Erbabacan, Pınar Kendigelen, Güniz M Köksal...

https://pubmed.ncbi.nlm.nih.gov/27366460

Combined effect of age and body mass index on postoperative mortality and morbidity in laparoscopic cholecystectomy patients.

Hana M A Fakhoury, Ziad Yousef, Hani Tamim...

https://pubmed.ncbi.nlm.nih.gov/38074287

Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study.

Hande Güngör, Bahadir Ciftci, Selcuk Alver...

https://pubmed.ncbi.nlm.nih.gov/36575362

Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia.

Serkan Tulgar, Onur Selvi, David Terence Thomas...

https://pubmed.ncbi.nlm.nih.gov/30639940

Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial.

Ayşegül Bilge, Betül Başaran, Tayfun Et...

https://pubmed.ncbi.nlm.nih.gov/36307755