Comparing Modified Thoracoabdominal Nerve Block Perichondrial Approach M-TAPA to Intravenous Opioids for Pain Relief After Laparoscopic Gallbladder Surgery
Led by Udayana University · Updated on 2024-10-22
42
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
A
Amelia Christiana, MD
I
Ita Indriani, MD
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Classified as American Society of Anesthesiologists (ASA) physical status I or II
You will not qualify if you...
Patient refusal to participate
Presence of local infection
Current use of chronic analgesic drugs
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
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
Ultrasound-guided bilateral modified-thoracoabdominal nerve block through a perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy: a randomized double-blind controlled trial.
Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study.
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...
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...