Elective Laproscopic Bilateral Inguinal Hernia Clinical Trial
Official title:
Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy : Prospective Double Blind, Randomized, Placebo-Controlled Study
A Prospective Double Blind RCT: Controlled Release Oxycodone 10 mg On a 12 h Dosing Schedule
Started With The Premedication ,Placebo Controlled Study,On Post Operative Analgesia
Management in Laparoscopic Cholecystectomy and Laparoscopic Bilateral Inguinal Hernia (BIH).
CRO is indicated for the management of moderate to severe pain when a continuous,around the
clock analgesic is needed for an extended period of time.Its safety and efficacy in the
first 12-24 hours post operative has not been established.
| Status | Not yet recruiting |
| Enrollment | 100 |
| Est. completion date | July 2008 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Local ethic committee approval - Written informed consent - ASA physical status I-III, scheduled for elective laparoscopic cholecystectomy and elective laparoscopic BIH Exclusion Criteria: - Difficulty in communication - Allergy to oxycodone and/or morphine - Allergy to local anesthetic - History of alcohol and substance abuse - Treated depression - Chronic use of opioid or tramadol or NSAIDS - Pregnancy - Obstructive sleep apnea - Anticipated fiber optic intubation - Severe hepatic or renal impairment - Weight <50 kg or > 100 kg - Conversion to laparotomy - Patient extubated in PACU. - Any prior abdominal surgery |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Kaplan Medical Center |