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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00942565
First received: July 20, 2009
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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 deprivation and mood disturbance. Opioid based patient-controlled analgesia (PCA) is commonly employed but opioids have the side effects such as respiratory depression, nausea and vomiting, sedation, pruritus and urinary retention. Bowel motility can also be affected. Consequently alternative or adjunct analgesic medications without these side-effects have been investigated in order to reduce opioid consumption.

Multimodal analgesia is a technique whereby a combination of analgesic drugs with different modes of action can be used to improve analgesia and decrease adverse effects by virtue of synergism. Postoperatively, with adjunctive analgesia, PCA morphine consumption as well as the side effects may be reduced. Non-steroidal anti-inflammatory drugs (NSAIDs) have been shown to be opioid sparing and decrease the adverse effects of PCA morphine. A recent review showed that acetaminophen combined with PCA could induce a significant opioid-sparing effect but the incidence of PCA morphine related side effects were not reduced.

It is common nowadays to give oral analgesic supplements to post-operative patients on PCA morphine. Tramadol, an analogue of codeine, is one of the choices. However, some of the patients cannot tolerate the side effects such as nausea, drowsiness, sweating, postural hypotension and dry mouth. Combination of tramadol 37.5 mg and acetaminophen 375 mg, which has been used successfully to treat post-operative pain, may improve analgesic response with better tolerability.

This study is to assess tramadol 37.5 mg and acetaminophen 375 mg combination on the efficacy of pain control, down stepping of morphine consumption and related adverse events with PCA use after open colorectal surgeries.

Objectives:

This study aims to compare and evaluate:

  • The efficacy of tramadol/acetaminophen combination on postoperative pain relief after lower abdominal surgeries
  • The effects of tramadol/acetaminophen combination on the consumption and the duration of PCA morphine use
  • The adverse effects related to this regimen
  • The effects on postoperative bowel function, tolerability of fluid and diet, ambulatory function, sleep, and duration of hospital stay
  • The overall satisfaction of the patients

Condition Intervention Phase
Postoperative Pain
Drug: tramadol/acetaminophen
Drug: acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Pain score [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2007
Study Completion Date: December 2012
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tramadol/acetaminophen
The tramadol and acetaminophen combination was given to patients at the same day after surgery.
Drug: tramadol/acetaminophen
Active Comparator: acetaminophen
Acetaminophen was used as active control.
Drug: acetaminophen

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942565

Locations
Hong Kong
Department of Anaesthesiology, The University of Hong Kong
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheung Chi Wai, Dr., The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00942565     History of Changes
Other Study ID Numbers: UW 06-188 T/1213
Study First Received: July 20, 2009
Last Updated: January 31, 2013
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
Open gynecological surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Acetaminophen
Tramadol
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Antipyretics
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014