Pain, PostoperativePhase 4NCT00236223
The Effect of Gabapentin, Ketamine and Dexamethasone on Pain and Opioid Requirements After Hip Surgery
A Phase 4 study testing Gabapentin + dexamethasone + ketamine in people with Pain, Postoperative, run by Glostrup University Hospital, Copenhagen at 2 sites in Denmark.
Trial summary
Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are unpleasant for the patients and sometimes keeps them at bed longer time than needed. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Gabapentin + dexamethasone + ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesDenmark
- Study dates
- Oct 2005to May 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 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for primary total hip replacement,
- Between 55 and 85 years of age,
- ASA 1-3 and BMI between 18 and 35.
Who cannot join
- Patients who are:
- Unable to cooperate
- Does not speak Danish
- Has allergy for drugs used in the trial
- Drug or alcohol abuse
- Epilepsy
Show all 12Show fewer
- Medically treated diabetes
- Known kidney disease
- Daily use of analgetics
- Apart from NSAID
- Paracetamol or COX2 inhibitors
- Are treated with a antidepressive.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Operations og Anæstesiologisk afd. Y, KAS Glostrup
Glostrup Municipality, 2600
Anæstesiafdelingen, Herning Centralsygehus
Herning, 7400
About this study
Official title: The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement
Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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
The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.
- Conditions
- Pain, Postoperative
- Being tested
- Gabapentin + dexamethasone + ketamine, Placebo
- Keywords
- Primary hip replacement, Gabapentin, Dexamethasone, Ketamine, 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.
Gabapentin + dexamethasone + ketamineDrug
Also called Anti-hyperalgesics, Postoperative pain
Comparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Gabapentin + dexamethasone + ketamine |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
Measured: 0-24h
Secondary outcomes (6)
Pain score (VAS)= at rest and at mobilisation.
Measured: 0-24h
Postoperative Nausea and vomiting.
Measured: 0-24h
Dizziness
Measured: 0-24h
Sedation
Measured: 0-24h
Nightmare and hallucinations.
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 posted12 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionApr 2008
- Study completionMay 2008
Why it stopped: Structural changes that stopped the type of operations used in the study
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT00236223
- Sponsor's protocol ID
- SM2-05
- Status last verified
- May 2008
- First submitted
- 7 Oct 2005
- Last updated
- 15 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gabapentin, Low Dose Ketamine, Paracetamol, NSAID and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Primary Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00236223
- Acronym / sponsor ID
- SM2-05
- Conditions
- Pain, Postoperative
- Keywords
- Primary hip replacement, Gabapentin, Dexamethasone, Ketamine, Multimodal postoperative analgesia.
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Structural changes that stopped the type of operations used in the study
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Oct 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.
Patients scheduled for primary hip replacement needs postoperative pain treatment, i.e. morphine. Morphine has side-effects: nausea, vomiting, sedation and dizziness. These side-effects are 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
The effect on postoperative pain of the combination of preoperative gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15mg/kg versus placebo is investigated on patients having a hip alloplastic operation.
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 |
|---|---|---|
| 1 | Experimental | Drug: Gabapentin + dexamethasone + ketamine |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for primary total hip replacement,
- Between 55 and 85 years of age,
- ASA 1-3 and BMI between 18 and 35.
Key exclusion criteria (12 listed)
- Unable to cooperate
- Does not speak Danish
- Has allergy for drugs used in the trial
- Drug or alcohol abuse
- Epilepsy
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 |
|---|---|---|
| Gabapentin + dexamethasone + ketamineAlso: Anti-hyperalgesics, Postoperative painComparing analgesic effect of gabapentin 1200 mg + dexamethasone 8 mg + ketamine 0.15 mg/kg | Drug | 1 |
| PlaceboMatching placebo | Drug | 2 |
Primary outcome
The total amount of morphine needed postoperatively from 0-4h; and 0-24h, administered by a patient controlled pain treatment.(PCA)
Time frame: 0-24h
6 secondary outcomes
Pain score (VAS)= at rest and at mobilisation.
Time frame: 0-24h
Postoperative Nausea and vomiting.
Time frame: 0-24h
Dizziness
Time frame: 0-24h
Sedation
Time frame: 0-24h
Nightmare and hallucinations.
Time frame: 0-24h
All measurements are taken at 2,4 and 24 h postoperatively.
Time frame: 0-24h
Results and safety
The study was stopped early (reason given: Structural changes that stopped the type of operations used in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 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 Gabapentin + dexamethasone + ketamine 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 3 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: stopped early, as of the sponsor's last update on 15 May 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 was stopped early (reason given: Structural changes that stopped the type of operations used in the study). Results are not available in the source record.
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 from 0-4h; and 0-24h, administered by a 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 15 May 2008.