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Clinical Trials/CTRI/2024/07/071713
CTRI/2024/07/071713Not yet recruitingNot Applicable

Comparison of postoperative analgesia in Ultrasound in Transversus Abdominis Plane block versus Laparoscopy assisted Transversus Abdominis Plane block in Laparoscopic Cholecystectomies in a Tertiary care center.

Not provided1 site in 1 country60 target enrollmentStarted: August 31, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
1)To compare the time to first rescue analgesic requirement in both the groups.

Study Overview

Brief Summary

The postgraduate in anaesthesiology will examine patients on the previous day for eligibility for inclusion in the study and take informed consent from eligible patients. Preoperative orders will be followed as per the consultant anaesthesiologist posted in the operation theater. The postgraduate will also observe the patients postoperatively. Standardized general anaesthesia will be administered followed by TAP block at the end of procedure either Laparoscopy assisted or Ultrasound guided based on the choice of consultant in the theatre.

After Extubation patients will be transferred to the Post-Anaesthetic Care Unit (PACU) for monitoring. Vital signs with pulse oximetry, electrocardiography, and non-invasive blood pressure will be continously monitored. Patients are routinely treated with injection paracetamol 1gm (every 8 hours) intravenously. Injection tramadol 50mg intravenously only if the patient complains of pain.

Patients will be assessed at specified intervals by the postgraduate during the postoperative period: immediately upon arrival at PACU and at   6,12 and 24 hours thereafter for Pain, PONV & any adverse effects of block. Pain intensity will be evaluated using a 10-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst pain). Time to first rescue analgesic and total tramadol consumption in the first 24hours will be noted. PONV will be evaluated using Impact scale score.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients undergoing elective laparoscopic cholecystectomy & TAP block as postoperative analgesia.
  • American Society of Anesthesiologists (ASA) physical status classification I-II.

Exclusion Criteria

  • Patient refusal.
  • Patient BMI greater than
  • Patient with history of allergy to the local anesthetic agent used in TAP block.

Outcomes

Primary Outcomes

1)To compare the time to first rescue analgesic requirement in both the groups.

Time Frame: In first 24hours.

2) To compare the total requirement of analgesics in the postoperative periods in both the groups.

Time Frame: In first 24hours.

Secondary Outcomes

  • To compare the effect of either blocks on postoperative nausea & vomiting & other effects of the block.(Immediately upon arrival at PACU ,6,12 & 24hours)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Khyati Modi

KMC Manipal

Study Sites (1)

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