To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Study Overview
Brief Summary
Post-operativepain after laparoscopic cholecystectomy is avery common complication hinderingearly return of routine activity. In various studies intraperitonealinstillation of local anaesthetics have been shown to be safe, effective andminimally invasive and opioids have shown to have a synergestic effect.Ropivacaine is shown to be more safe and efficacious as compared to other localanaesthetics such as bupivacaine. Similarly, nalbuphine is better than otheropioids due to its mixed action on opioid receptors. Since agonist opioids arenot available with us, the most common drug used for intraoperative analgesiais IV butorphanol. So the purpose of our study is to compare the effect of intraperitonealbutorphanol with intraperitoneal nalbuphine for laparoscopic cholecystectomy.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.ASA physical status I and II.
- •2.Elective laparoscopic cholecystectomy.
Exclusion Criteria
- •1.Acute cholecystitis.
- •2.Carcinoma Gall bladder.
- •3.Hypersensitivity to study drugs.
- •4.Pregnant females.
- •5.Bleeding disorders.
- •6.Opioid addicts.
- •7.Patient refusal to participate in the study.
Outcomes
Primary Outcomes
To compare the efficacy of intraperitoneal instillation of ropivacaine and butorphanol versus ropivacaine and nalbuphine for post-operative pain relief in patients undergoing laparoscopic cholecystectomy under general anaesthesia.
Time Frame: After extubation of patient till 24 hours.
Secondary Outcomes
- To compare the timing of first request and frequency of rescue analgesia.(After extubation of patient till 24 hours.)