None listed
Conditions
Brief summary
Pain is inadequately treated in many of the surgical procedures. Postoperative pain is the main reason for the prolonged convalescence after laparoscopic (key hole) gall bladder surgery. Severe postoperative pain after gall bladder surgery can cause significant long standing pain, if not adequately treated initially. Postoperative pain has been traditionally treated with opioids, non steroidal anti-inflammatory agents and paracetamol. Opioids are associated with significant side effects and constant search for an alternative agent with similar potency and minimal side effects has been on for a very long time. Pregabalin and Gabapentin have recently elicited a lot of interest as being useful drugs for postoperative pain relief. Pregabalin has got a lot of pharmacokinetic advantages over Gabapentin as being more potent and more bioavailable with very minimal side effects. When combined with drugs like celecoxib, which are the safer versions of anti-inflammatory drugs as of current evidence, Pregabalin is likely to exhibit synergistic effect. This project evaluates the efficacy of Pregabalin, Celecoxib and their combination to treat postoperative pain in patients undergoing laparoscopic gall bladder surgery. This will be a randomized, double blind study. Selected participants will be given pregabalin, celecoxib or their combination or their placebo before and after surgery. They will be given standard general anaesthesia according to protocol. Their pain scores after surgery, demand for pain killers, anxiety levels, satisfaction with pain relief and other side effects will be recorded by a nurse. Statistical analysis will be made with the above observations to evaluate the efficacy of the study drugs. If this research yields positive result, it can add on to the evidence for using a different group of drugs for relief of acute postoperative pain as opposed to conventional pain relief with opioids. Also, the same group of drugs may be trialled in future for minimising the occurrence of chronic pain after surgery.
Interventions
premedication 1 hour before the surgery with
Group pregabalin: pregabalin 150 mg + matched celecoxib placebo orally
Group celecoxib: celecoxib 400 mg + pregabalin placebo orally
Group pregabalin/celecoxib: pregabalin 150 mg + celecoxib 400 mg orally
Group placebo: pregabalin placebo + celecoxib placebo orally
Matched celecoxib and pregabalin placebos are identical in shape, size and colour to celecoxib and pregabalin tablets, but they differ from the original tablets in that they contain n
premedication 1 hour before the surgery with Group pregabalin: pregabalin 150 mg + matched celecoxib placebo orally Group celecoxib: celecoxib 400 mg + pregabalin placebo orally Group pregabalin/celecoxib: pregabalin 150 mg + celecoxib 400 mg orally Group placebo: pregabalin placebo + celecoxib placebo orally Matched celecoxib and pregabalin placebos are identical in shape, size and colour to celecoxib and pregabalin tablets, but they differ from the original tablets in that they contain no active ingredients. 12 hours after the premedication, second dose of study drugs (pregabalin 150 mg/ celecoxib 200 mg/ combination/ placebo) given.
Sponsors
Usha Gurunathan
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
ASA I/II patients, 18-70 years, undergoing laparoscopic cholecystectomy with minimal or no health issues.
Exclusion criteria
1. patients with significantly established IHD( angina, MI, heart failure) /peripheral arterial disease/cerebrovascular disease, patients with NYHA II-IV functional capacity classification of heart failure, uncontrolled DM, Hypertension. 2. ASA>2 3. patients with dizziness 4. history of peptic ulcer 5. pregnancy or lactation 6. patients on anticonvulsants, antidepressants 7. impaired kidney, liver function 8. obese( patients> BMI 40) 9. psychiatric disorders, drug/alcohol abuse 10. history of aspirin sensitive asthma, known hypersensitivity to celecoxib or sulphonamides, history of allergic-type reactions after aspirin or NSAIDs. 11. history of epilepsy 12. patients receiving analgesics/sedatives ( opioids incl. tramadol, acetaminophen, NSAIDs) within 24 hours preoperatively 13.Conversion to open cholecystectomy, bile spillage, insertion of drain.
Outcome results
None listed