Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
tramadol/acetaminophen
acetaminophen
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Open gynecological surgery
Eligibility 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
Sites / Locations
- Department of Anaesthesiology, The University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Tramadol/acetaminophen
acetaminophen
Arm Description
The tramadol and acetaminophen combination was given to patients at the same day after surgery.
Acetaminophen was used as active control.
Outcomes
Primary Outcome Measures
Pain score
Secondary Outcome Measures
postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction
Full Information
NCT ID
NCT00942565
First Posted
July 20, 2009
Last Updated
January 31, 2013
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT00942565
Brief Title
Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
5. Study Description
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
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 be prescribed. Patients will be induced with fentanyl 1 to1.5µg/kg, thiopentone 2-4mg/kg or propofol 2-3mg/kg and rocuronium 1mg/kg. Anaesthesia will be maintained with cisatracurium and isoflurane with air and oxygen. Intravenous morphine will be used for pain relief intraoperatively.
Postoperative PCA settings
After the operation, at the recovery area, patients will be given boluses of intravenous morphine until satisfactory pain control, i.e. numerical rating scale (NRS) less than 4. PCA machine will then be connected and patient will learn the technique of using PCA. The PCA pump will be programmed as follow:
Each bolus: 1 to 1.5mg Lockout interval: 5 minutes Maximum hourly dose limit: 0.1mg/kg for patients up to 65 years old and 0.075mg/kg for patients over 65 No background morphine infusion will be given. Intramuscular pethidine 0.5mg/kg four-hourly will be prescribed as rescue pain medications. Patients will be assessed everyday by the pain team of the hospital.
Randomisation and blinding
Patients will be randomised to one of the following 2 groups:
Group T: Tramadol 37.5mg / acetaminophen 325mg: 1 tablet 3 times daily orally Group P: Acetaminophen 500mg 3 times daily A computer-generated random sequence will decide the allocation order. The appearance of acetaminophen looks similar to the tramadol/acetaminophen combination. Both pain team members and patients will be blinded to the study medications. The study medications will be used for 48 hours after operation.
Follow-up and assessments Patients will be assessed each morning by the pain team. The daily average pain score at rest and during cough will be recorded in numerical rating scale (NRS). Average daily pain intensity (0=none, 1=mild, 2=moderate, 3=severe) and average daily relief (4=complete relief, 3=a lot, 2=moderate, 1=slight, 0=no, -1=worse pain) will be assessed. The tries/good ratio shown on PCA machine and the total amount of morphine used, daily rescue pain drug consumption will be charted. The adverse effects (nausea, vomiting, pruritus, dizziness, and others) will be recorded with their frequencies and severity graded. Sedation will be assessed based on the scale shown.
The ambulatory function, tolerability of fluid and diet and bowel function will also be assessed. Sleeping quality will be evaluated using NRS and reason for it asked.
The PCA machine will be off if the NRS pain score on cough is less than 4. Patients will then grade their overall satisfaction of pain relief at postoperative day 3.
Data Collection
Efficacy
Resting and coughing NRS pain scores,
Average daily pain intensity and average daily relief
Tries/good ratio, cumulative morphine consumption,
Rescue pain drug consumption every day until 2 days after stopping PCA
Overall patient's satisfaction using NRS
Safety
- Adverse effects and their severity, sedation, ambulatory function, tolerability of fluid and diet, bowel function, and sleeping quality every day until off PCA
Demographics
Age
Sex
Body weight
ASA grading
Operation duration
Intraoperative opioids
Morphine consumption at recovery room
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Open gynecological surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tramadol/acetaminophen
Arm Type
Active Comparator
Arm Description
The tramadol and acetaminophen combination was given to patients at the same day after surgery.
Arm Title
acetaminophen
Arm Type
Active Comparator
Arm Description
Acetaminophen was used as active control.
Intervention Type
Drug
Intervention Name(s)
tramadol/acetaminophen
Intervention Type
Drug
Intervention Name(s)
acetaminophen
Primary Outcome Measure Information:
Title
Pain score
Time Frame
Postoperative 48 hours
Secondary Outcome Measure Information:
Title
postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction
Time Frame
Postoperative 48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Anaesthesiology, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
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