CompletedPhase 3Phase 4ACTRN12612000447853

How effective are the drugs pregabalin and celecoxib in relieving pain after laparoscopic gall bladder surgery?

The effect of pregabalin and celecoxib on the analgesic requirements after laparoscopic cholecystectomy


Sponsor

Usha Gurunathan

Enrollment

100 participants

Start Date

Jul 13, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria1

  • ASA I/II patients, 18-70 years, undergoing laparoscopic cholecystectomy with minimal or no health issues.

Exclusion Criteria13

  • 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.
  • ASA>2
  • patients with dizziness
  • history of peptic ulcer
  • pregnancy or lactation
  • patients on anticonvulsants, antidepressants
  • impaired kidney, liver function
  • obese( patients> BMI 40)
  • psychiatric disorders, drug/alcohol abuse
  • history of aspirin sensitive asthma, known hypersensitivity to celecoxib or sulphonamides, history of allergic-type reactions after aspirin or NSAIDs.
  • history of epilepsy
  • patients receiving analgesics/sedatives ( opioids incl. tramadol, acetaminophen, NSAIDs) within 24 hours preoperatively
  • Conversion to open cholecystectomy, bile spillage, insertion of drain.

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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 pregab

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.


Locations(1)

The Prince Charles Hospital - Chermside

QLD, Australia

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ACTRN12612000447853