Pain, PostoperativePhase 4NCT00209495
Effect of Paracetamol,Pregabalin and Dexamethasone on Pain and Opioid Requirements in Postoperative Patients
A Phase 4 study testing Pregabalin; Dexamethasone in people with Pain, Postoperative, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Pregabalin; Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 2 sitesDenmark
- Study dates
- Jun 2005to Feb 2008
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
- BMI between 18-32.
Who cannot join
- Patients who:
- Are unable to cooperate
- Has cancer ovarian
- Does not speak Danish
- Has allergy for drugs used in the trial
- Has drug and medicine abuse
Show all 12Show fewer
- Epilepsy
- Diabetes treated with medicine
- Chronic pain condition
- Daily use of antacids or analgesic
- Known kidney disease
- Use of antidepressive
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup Municipality, Copenhagen, 2600
Herning Centralsygehus
Herning, 7400
About this study
Official title: Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
Read the detailed description
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
- Conditions
- Pain, Postoperative
- Being tested
- Pregabalin; Dexamethasone
- Keywords
- Abdominal hysterectomy, Pregabalin, Dexamethasone, Multimodal postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregabalin; DexamethasoneDrug
Comparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | Not described Receives: Drug: Pregabalin; Dexamethasone |
| B | Experimental | Pregabalin Receives: Drug: Pregabalin; Dexamethasone |
| C | Experimental | Pregabalin + dexamethasone Receives: Drug: Pregabalin; Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
Measured: 0 - 24h
Secondary outcomes (5)
Pain Score (VAS) at rest and at mobilisation.
Measured: 0 - 24h
Postoperative nausea and vomiting.
Measured: 0 - 24h
Sedation.
Measured: 0 - 24h
Dizziness.
Measured: 0 - 24h
All measurements are taken at 2, 4 and 24 h postoperatively.
Measured: 0 - 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionNov 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Ole Mathiesen, MD, Principal investigator, Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209495
- Sponsor's protocol ID
- SM1-04
- Status last verified
- Feb 2008
- First submitted
- 13 Sep 2005
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Abdominal Hysterectomy.
- ClinicalTrials.gov ID
- NCT00209495
- Acronym / sponsor ID
- SM1-04
- Conditions
- Pain, Postoperative
- Keywords
- Abdominal hysterectomy, Pregabalin, Dexamethasone, Multimodal postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Nov 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 Sep 2005 (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.
Women scheduled for abdominal hysterectomy needs postoperative pain treatment, i.e. morphine. Unfortunately morphine has side-effect: nausea, vomiting, sedation and dizziness, which is unpleasant for the patients and sometimes keeps them at bed longer time than needed. We investigate in new combinations of analgesics for postoperative pain, hoping to minimize the need for morphine.
Detailed description
Combinations of paracetamol versus paracetamol + pregabalin versus paracetamol + pregabalin + dexamethasone is investigated. Primary outcome is 24 hours morphine usage.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: Pregabalin; Dexamethasone |
| B | Experimental | Drug: Pregabalin; DexamethasonePregabalin |
| C | Experimental | Drug: Pregabalin; DexamethasonePregabalin + dexamethasone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women scheduled for abdominal hysterectomy, between the age of 18 and 75, ASA 1-2
- BMI between 18-32.
Key exclusion criteria (12 listed)
- Are unable to cooperate
- Has cancer ovarian
- Does not speak Danish
- Has allergy for drugs used in the trial
- Has drug and medicine abuse
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 |
|---|---|---|
| Pregabalin; DexamethasoneComparing combinations of paracetamol + pregabalin 300 mg + dexamethasone 8 mg | Drug | A, B, C |
Primary outcome
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA)
Time frame: 0 - 24h
5 secondary outcomes
Pain Score (VAS) at rest and at mobilisation.
Time frame: 0 - 24h
Postoperative nausea and vomiting.
Time frame: 0 - 24h
Sedation.
Time frame: 0 - 24h
Dizziness.
Time frame: 0 - 24h
All measurements are taken at 2, 4 and 24 h postoperatively.
Time frame: 0 - 24h
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 29 Feb 2008.
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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.
Ole Mathiesen, MD principal investigator
Department of Anaesthesiology, Copenhagen University Hospital in Glostrup, 2600 Glostrup, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregabalin; Dexamethasone in people with Pain, Postoperative, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
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 2 inclusion and 12 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 29 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
The total amount of morphine needed postoperatively form 0 - 4 h, and 0 - 24 h, administered by the patient controlled pain treatment. (PCA) (time frame: 0 - 24h). 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 29 Feb 2008.