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.
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:
- 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).
- After intubation, the TAP block will be performed bilaterally under ultrasound guidance by an experienced anesthesiologist.
- 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
Sara Zubair
Institute of medical science and sum hospital