Controlled Release of Oxycodone 10 mg In Pre-Medication For The Post Operative Analgesia In Elective Laparoscopic Bilateral Inguinal Hernia And Elective Laparoscopic Cholecystectomy

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00480142

Enrollment

100

Registered

2007-05-30

Start date

2007-07-31

Completion date

2008-07-31

Last updated

2007-06-06

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

Conditions

Elective Laproscopic Bilateral Inguinal Hernia, Elective Laproscopic Cholecystectomy

Brief summary

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.

Interventions

DRUGOxycodone 10 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Contacts

Primary ContactOscar Liphshitz, MD

liphshitz@clalit.org.il0524782736

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026