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

NCT00942565 | Completed Phase 4

• 1 other identifier: UW 06-188 T/1213
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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

Conditions

Postoperative Pain

Keywords

Open gynecological surgery

Outcome Measures

Primary Outcomes (1)

• Pain score

  Postoperative 48 hours

Secondary Outcomes (1)

• postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction

  Postoperative 48 hours

Study Arms (2)

Tramadol/acetaminophen

ACTIVE COMPARATOR

The tramadol and acetaminophen combination was given to patients at the same day after surgery.

Drug: tramadol/acetaminophen

acetaminophen

ACTIVE COMPARATOR

Acetaminophen was used as active control.

Drug: acetaminophen

Interventions

tramadol/acetaminophen DRUG

Tramadol/acetaminophen

acetaminophen DRUG

acetaminophen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Anaesthesiology, The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ultracet; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 21, 2009
• Study Start: April 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: December 1, 2012
• Last Updated: February 1, 2013

Record last verified: 2013-01

Locations

HK (1)