Postoperative PainPhase 4NCT00942565
Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
A Phase 4 study testing tramadol/acetaminophen and acetaminophen in people with Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- tramadol/acetaminophen and acetaminophen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- Apr 2007to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Anaesthesiology, The University of Hong Kong
Hong Kong
About this study
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.
Read more
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
Read the 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
- Conditions
- Postoperative Pain
- Being tested
- tramadol/acetaminophen, acetaminophen
- Keywords
- Open gynecological surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadol/acetaminophenDrug
acetaminophenDrug
| Study group | Role | What they receive |
|---|---|---|
| Tramadol/acetaminophen | Active comparator | The tramadol and acetaminophen combination was given to patients at the same day after surgery. Receives: Drug: tramadol/acetaminophen |
| acetaminophen | Active comparator | Acetaminophen was used as active control. Receives: Drug: acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Measured: Postoperative 48 hours
Secondary outcomes (1)
postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction
Measured: Postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Chi Wai, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942565
- Sponsor's protocol ID
- UW 06-188 T/1213
- Status last verified
- Jan 2013
- First submitted
- 20 Jul 2009
- Last updated
- 1 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Analgesic Effects of Low Dose Tramadol/Acetaminophen Combination After Open Gynaecological Surgery
- ClinicalTrials.gov ID
- NCT00942565
- Acronym / sponsor ID
- UW 06-188 T/1213
- Conditions
- Postoperative Pain
- Keywords
- Open gynecological surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tramadol/acetaminophen | Active comparator | Drug: tramadol/acetaminophenThe tramadol and acetaminophen combination was given to patients at the same day after surgery. |
| acetaminophen | Active comparator | Drug: acetaminophenAcetaminophen was used as active control. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tramadol/acetaminophen | Drug | Tramadol/acetaminophen |
| acetaminophen | Drug | acetaminophen |
Primary outcome
Pain score
Time frame: Postoperative 48 hours
1 secondary outcome
postoperative morphine consumption, side effect, recovery, sleeping quality, satisfaction
Time frame: Postoperative 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tramadol/acetaminophen and acetaminophen in people with Postoperative Pain, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Postoperative 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.