POST OPERATIVE ANALGESIC EFFICACY OF MODIFIED THORACO ABDOMINAL PLANE BLOCK VS LOCAL ANESTHETIC INFILTRATION AT PORT SITE IN LAPAROSCOPIC CHOLECYSTECTOMY
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- To compare the requirement of rescue analgesic IV Fentanyl in both groups for 24 hours.
Study Overview
Brief Summary
Aim of study is to compare analgesic effectiveness of Modified thoracoabdominal nerve block via perichondrial approach(MTAPA) vs LA infiltration at port site in elective laparoscopic cholecystectomy surgeries.
Seventy patients will be enrolled for this study after inclusion and exclusion criteria. They will be allocated to one of the two groups
Written informed consent will be taken from the patients.
Group L = patients will receive local anesthetic at incision sites
Group M = patients will receive ultrasound guided MTAPA block after suturing incision sites
Following the end of the surgical operation, MTAPA/LA infiltration will be performed before reversing the patient’s from general anaesthesia. patient will be transferred to the postoperative recovery room(PACU).
Patients in both groups will receive i.v. Paracetamol 1gm 8hourly
Diclofenac 75mg if NRS>3
Fentanyl as rescue analgesic
Patient will be assessed for pain by anaesthesia resident blinded to group allocation at Â,½, 2, 4, 6, 8,12 and 24hrs in recovery room.
The severity of pain at rest and movement will be assessed using Numeric Pain Scale (NRS).
Total postoperative Analgesic consumption - (PCA fentanyl) will be recorded , Total requirement of rescue analgesic (fentanyl) for NRS >5, will be recorded.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients scheduled for elective laparoscopic cholecystectomy. Age.
- •18 years to 60 years American Society of Anesthesiologists (ASA) physical status classification I-II.
Exclusion Criteria
- •Known allergy to local anesthetic agent (bupivacaine) infection at the injection site history of abdominal surgery pregnancy.
Outcomes
Primary Outcomes
To compare the requirement of rescue analgesic IV Fentanyl in both groups for 24 hours.
Time Frame: Immediate post op | 30 min post op | 1hr post op | 2hr post op | 4 hr post op | 6hr post op | 8hr post op | 12 hr post op | 24 hr post op
Secondary Outcomes
- To compare the requirement of rescue antiemetic IV metoclopramide in both the groups for 24 hours.(To compare the hemodynamics in both the groups for 24 hours.)