Status:

COMPLETED

Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery

Lead Sponsor:

The University of Hong Kong

Conditions:

Postoperative Pain

Eligibility:

FEMALE

18-80 years

Phase:

PHASE4

Brief Summary

Patient experience moderate to severe pain after abdominal surgery. This post-operative pain can also contribute to complications such as respiratory impairment, cardiovascular events, ileus, sleep de...

Detailed Description

This is a randomized, double-blinded, placebo-controlled study. Study site Patients will be recruited and studied at Queen Mary Hospital, Hong Kong. Anaesthesia for operation No premedication will b...

Eligibility Criteria

Inclusion

  • ASA I to III
  • Age 18 to 80 years
  • Scheduled for elective lower abdominal surgery (gynecological or colorectal surgery) at Queen Mary Hospital, Hong Kong

Exclusion

  • Allergy to tramadol, acetaminophen, or other opioid drugs
  • Patient with epilepsy or history of seizures
  • Concurrent use of selective serotonin uptake inhibitors, tricyclic antidepressants, or monoamine oxidase inhibitors
  • Impaired or retarded mental state
  • Impaired renal function, defined as preoperative serum creatinine level over 120µmol/L
  • Impaired hepatic function, defined as preoperative serum albumin level less than 30g/L
  • Intraoperative use of clonidine or dexmedetomidine
  • Patient requiring postoperative mechanical ventilation
  • Difficulties in using patient-controlled analgesia
  • Pregnancy
  • Current or previous drug abuser
  • Alcoholism
  • Patient refusal

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00942565

Start Date

April 1 2007

End Date

December 1 2012

Last Update

February 1 2013

Active Locations (1)

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Department of Anaesthesiology, The University of Hong Kong

Hong Kong, Hong Kong