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Clinical Trials/CTRI/2025/07/091732
CTRI/2025/07/091732Not yet recruitingNot Applicable

Preemptive Ultrasound guided Modified Thoracoabdominal nerve block via perichondrial approach (M - TAPA) vs oblique subcostal transversus abdominis plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy under general anaesthesia - A Randomised controlled trial

Dr B R Ambedkar medical college and hospital1 site in 1 country60 target enrollmentStarted: August 4, 2025Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups

Study Overview

Brief Summary

Laparoscopic cholecystectomy (LC) is a frequently performed surgery as the gold standard in the treatment of symptomatic gallstone disease. Despite the introduction of a  minimally invasive approach, cholecystectomy can cause significant postoperative pain owing to multifactorial factors.  Acute postoperative pain is the most common cause of patient discomfort during the period after LC and is the most common cause of readmission after discharge. Poorly controlled postoperative pain impairs the quality of recovery, increasing the risk of postoperative pulmonary complications as risk factor for the formation of chronic pain. It was observed that the abdominal pain following LC mostly originates from the incision area, and the remaining part consists of visceral and referred pain. Multimodal analgesia, including opioids is used to limit pain following LC. Treatment with opioids might cause side effects for example postoperative nausea and vomiting, constipation, respiratory depression. Oblique subcostal transverse abdominis plane block (OSTAP) provides a wide range of analgesia from T7 – T12, is effective for 6 – 18h postoperatively, however it requires multiple injections to achieve complete analgesia. Modified thoracoabdominal nerve block through perichondrial approach (M – TAPA)  is a newer technique which has received increasing attention due to its wide range of analgesic coverage of the trunk (that is T5 – T12)  with a single puncture per side and has been  reported to provide a long acting effect. M – TAPA offers blocking both anterior and lateral cutaneous branches of the thoracoabdominal nerves, surpassing the limitations of conventional techniques such as transversus abdominis plane block. We hypothesize that M – TAPA block would be more effective than OSTAP block for controlling postoperative pain, considering its range of efficacy and long term durability.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients posted for elective laparoscopic cholecystectomy under general anaesthesia.
  • Patients aged between 18 to 75y.
  • Patients belonging to American Society of Anaesthesiologists physical status (ASA.
  • PS) 1 and 2.

Exclusion Criteria

  • Known allergy to the local anaesthetics given.
  • Patients with chronic pain on slow-release preparations of opioid, drug or alcohol abuse.
  • Patients with dementia or cognitive problems.
  • Patients with BMI more than 35 kg/m
  • Patients who are known case of diabetes mellitus.

Outcomes

Primary Outcomes

To assess the duration of postoperative analgesia following laparoscopic cholecystectomy in both groups

Time Frame: The time period from administration of block till first rescue analgesia for first 24 postoperative hours

Secondary Outcomes

  • To compare total analgesic consumption during postoperative period over 24 hours in both groups.(To assess the adverse effects associated with analgesics such as nausea, vomiting.)

Investigators

Sponsor
Dr B R Ambedkar medical college and hospital
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Deepak Vijaykumar Kadlimatti

Dr B R Ambedkar medical college and hospital

Study Sites (1)

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