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Randomised study comparing pre-emptive versus post-operative analgesia at port sites during laparoscopic cholecystectomy

A Randomized Controlled Trial to Compare Pain Relief in Pre-Emptive Versus Post-Operative Local Anesthetics Infiltration at Port Site Incision in Patient Undergoing Laparoscopic Cholecystectomy. - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056175
Enrollment
50
Registered
2023-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: pre-emptive infiltration of local anaesthetic at port sites: Patient in this group will receive port site infiltration of 20 ml 0.5% bupivacaine at the beginning of surgery {6ml at 10 m

Sponsors

All India Institute of Medical SciencesAIIMS New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients undergoing laparoscopic cholecystectomy for symptomatic gall stone disease. 2. BMI 3. 18 to 65 years of age both male and female 4. Weight > 50 kg 5. Patient is able to follow instructions 6. Able to provide informed written consent

Exclusion criteria

Exclusion criteria: 1. Age > 65 or 2. BMI > 35 3. Patient with history of ERCP, Cholecystitis, Pancreatitis 4. Unable to give consent or patient refusal 5. Unfit for general anaesthesia 6. Pregnancy 7. Converted to open 8. Prior upper abdominal surgery 9. Difficult cholecystectomy with operative duration more than 60 minutes

Design outcomes

Primary

MeasureTime frame
To compare the average pain score (VAS) between two groupsTimepoint: 1,3,6,12, 24 hrs

Secondary

MeasureTime frame
To compare the length of hospital stay Timepoint: 24, 48 HRS;To compare the time to the first analgesic request (considering time at extubation to be zero) Timepoint: 24HRS;To correlate level of intraoperative dissection with post operative pain Timepoint: 24HRS

Countries

India

Contacts

Public ContactDr Devender Singh

All India Institute of Medical Sciences(AIIMS), New Delhi

devinderkuntal@gmail.com9813643337

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026