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A study to compare the effectiveness of administering ketamine, levo-bupivacaine and a combination of both into the abdominal cavity for reducing post surgical pain in patients after keyhole surgery for gall bladder removal

A comparative study to evaluate the effectiveness of intraperitoneal instillation of ketamine, levo-bupivacaine and both for postoperative analgesia in patients undergoing laparoscopic cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/019969
Enrollment
90
Registered
2019-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: GROUP B: Group B :will receive intraperitoneal instillation of 0.5% levo-bupivacine at 2mg/kg diluted with saline to make a total of 30 ml Intervention2: GROUP C: Group C : will receive

Sponsors

Amala Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of either sex,between age 18 years-70years,ASA physical status 1-3,who are scheduled for laparoscopic cholecystectomy under General Anesthesia and are willing and able to give informed consent will be recruited to the trial

Exclusion criteria

Exclusion criteria: Patients were excluded if 1. they had a clinical diagnosis of acute pancreatitis 2. acute preoperative pain other than biliary colic 3. chronic pain treatment 4. anti-epileptic therapy 5. history of alcohol or drug addiction 6. severe hepatic or renal impairment 7. allergy to the study drugs 8. cognitive impairment or communication problems 9. pregnant or lactating 10. conversion to open cholecystectomy

Design outcomes

Primary

MeasureTime frame
24 hour total rescue analgesic (diclofenac +/-tramadol) consumption Timepoint: at 24 hours post operatively

Secondary

MeasureTime frame
Reduction of postoperative pain scores,Time to first requirement of rescue analgesia, time to unassisted ambulation and Tolerability of the used doses represented by the side effects.Timepoint: At 6h 12h and 24 hours post operatively

Countries

India

Contacts

Public ContactDR DERLIN THOMAS

Amala Institute of Medical Sciences

derlin.t@gmail.com09447768944

Outcome results

None listed

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