Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
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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 |
- Pain score [ Time Frame: Postoperative 48 hours ] [ Designated as safety issue: No ]
- 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 |
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 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 Postoperative Complications Pathologic Processes Pain Signs and Symptoms Acetaminophen Tramadol Antipyretics Physiological Effects of Drugs Pharmacologic Actions |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Narcotics Central Nervous System Depressants Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013