CTRI/2024/09/073692
Recruiting
Phase 4
The analgesic effect and patient satisfaction following bupivacaine infiltration in the extra peritoneal space in patients undergoing laparocopic TAPP repair for unilateral inguinal hernias A Randomized controlled Trial
AIIMS Jodhpur Research Section1 site in 1 country202 target enrollmentStarted: September 21, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- AIIMS Jodhpur Research Section
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Analgesic effect of bupivacine infiltration into port wounds and extraperitoneal space compared to placebo (normal saline) after 6 ,12 , 24 hours of surgery
Overview
Brief Summary
The study will include all adult male inguinal hernia patients undergoing TAPP. Total 202 patients will be randomized for the study just before the procedure. The study patients will be introduced with infiltration of 0.5% bupivacaine and other patients will be introduced with normal saline in the extra-peritoneal space and port site. The study patients will be compared for postoperative outcomes likes pain at 6, 12 and 24 hours after surgery
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Male
Inclusion Criteria
- •All male patients between specified age undergoing unilateral TAPP will be included.
Exclusion Criteria
- •Recuurent hernia , Previous laparotomy ,substance abuse or opium addiction , psychiatric patients, uncontrolled comorbidities, history of drug allergy.
Outcomes
Primary Outcomes
Analgesic effect of bupivacine infiltration into port wounds and extraperitoneal space compared to placebo (normal saline) after 6 ,12 , 24 hours of surgery
Time Frame: VAS pain score after 6 ,12 , 24 hours of surgery
Secondary Outcomes
- To compare patient satisfaction level(At time of discharge from the hospital ( 1 or 2 days after OT ))
Investigators
Dr Satya Prakash Meena
AIIMS Jodhpur
Study Sites (1)
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