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Clinical Trials/CTRI/2025/02/080918
CTRI/2025/02/080918
Not yet recruiting
Phase 4

Effectiveness of Ultrasound guided- Transverse Abdominis Plane Block using Ketamine with Bupivacaine versus Dexamethasone with Bupivacaine for post operative analgesia in patient undergoing Total Laproscopic Hysterectomy- a prospective randomized double blinded study.

IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha1 site in 1 country60 target enrollmentStarted: February 24, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha
Enrollment
60
Locations
1
Primary Endpoint
To measure the duration of post operative analgesia and time required for primary dose of rescue analgesic after surgery.

Overview

Brief Summary

This prospective, randomized, double-blind, comparative study will assess the efficacy of ultrasound-guided transverse abdominis plane (TAP) blocks with ketamine or dexamethasone as adjuvants to 0.5% bupivacaine in 60 patients undergoing total laparoscopic hysterectomy. The patients, aged 30–70 years (ASA grade I and II), will be divided into two groups of 30 each:

  • Group BD: TAP block with 0.5% bupivacaine + ketamine (0.5 mg/kg), total 20 mL.
  • Group BK: TAP block with 0.5% bupivacaine + dexamethasone (8 mg), total 20 mL.

Procedure Overview:

  1. Patients will be prepared with standard preoperative protocols, including IV access, standard monitors, and administration of premedications (ondansetron, pantoprazole, glycopyrrolate, midazolam, fentanyl, propofol, and vecuronium).
  2. After intubation, the TAP block will be performed bilaterally under ultrasound guidance by an experienced anesthesiologist.
  3. Surgery will proceed under general anesthesia with isoflurane, nitrous oxide, oxygen, and intermittent vecuronium. Pain management intraoperatively includes fentanyl boluses and diclofenac.

Postoperative Monitoring:

  • Patients will be monitored for pain using VAS scores and tramadol consumption.
  • Ondansetron will be given for vomiting, and tramadol for pain (VAS > 4).
  • At 24 hours, patients will rate pain relief satisfaction on a 4-point scale.

The study aims to compare pain relief, tramadol consumption, and patient satisfaction between the two groups.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
30.00 Year(s) to 70.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • Patients of age 30-70yrs Patients under ASA I and ASA II Patient undergoing elective total laproscopic hysterectomy.

Exclusion Criteria

  • Patient’s refusal to participate in the study Patient taking anticoagulants Have an allergy or contraindication to the drug used Alcohol or drug abuse Have infection near the block site Have clinically significant neurological, cardiovascular, renal or hepatic disease.
  • ASA III-IV patients Having mental disorder which interferes with visual analogue scale (VAS) evaluation were excluded from the study.

Outcomes

Primary Outcomes

To measure the duration of post operative analgesia and time required for primary dose of rescue analgesic after surgery.

Time Frame: Pain scores at 0, 2, 6, 8, 12, 24 hours post surgery.

To compare nad assess pain scores with bupivacaine plus ketamine versus bupivacaine plus dexamethasone post surgery surgery.

Time Frame: Pain scores at 0, 2, 6, 8, 12, 24 hours post surgery.

Secondary Outcomes

  • Vital monitoring( heart rate, BP & spO2) during intra operative period.(Patient satisfaction score(excellent, good, fair, poor))

Investigators

Sponsor
IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Sara Zubair

Institute of medical science and sum hospital

Study Sites (1)

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