Total Hip ReplacementPhase 3NCT00219921
Postoperative Analgesia After Total Hip Replacement
A Phase 3 study of Total Hip Replacement, run by Rijnstate Hospital.
Trial summary
There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Total Hip Replacement
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Feb 2007
- Phase
- Phase 3
- 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower
Who cannot join
- Not able to speak dutch
- communication problems
- dementia
- mental retardation
About this study
There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.
Read the detailed description
This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.
VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.
- Conditions
- Total Hip Replacement
- Being tested
- Intrathecal morphine at surgery, 0.1mg and placebo, Patient Controlled Analgesia with iv morphine and placebo, intrathecal morphine AND patient controlled analgesia with iv morphine
- Keywords
- total hip replacement, pain treatment
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphine at surgery, 0.1mg and placeboDrug
Patient Controlled Analgesia with iv morphine and placeboDrug
intrathecal morphine AND patient controlled analgesia with iv morphineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS-score for pain at movement and at rest every three hours
PCA-bolus-sum every three-hour period
Morphine-IM rescue dose every three-hour period
Secondary outcomes (7)
patient satisfaction each 24 hours
iv-morphine dose needed to attain VAS-score under 40 mm
PONV every three hours
urine retention every three hours
itching every three hours
decrease in saturation every three hours
quality of physical training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sibrand Houtman, MD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219921
- Sponsor's protocol ID
- LTC-349-030905
- Status last verified
- Mar 2007
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00219921
- Acronym / sponsor ID
- LTC-349-030905
- Conditions
- Total Hip Replacement
- Keywords
- total hip replacement, pain treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Feb 2007 (actual)
- First posted
- 22 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.
There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.
Detailed description
This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.
VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower
Key exclusion criteria (4 listed)
- Not able to speak dutch
- communication problems
- dementia
- mental retardation
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 |
|---|---|---|
| Intrathecal morphine at surgery, 0.1mg and placebo | Drug | – |
| Patient Controlled Analgesia with iv morphine and placebo | Drug | – |
| intrathecal morphine AND patient controlled analgesia with iv morphine | Drug | – |
Primary outcome
VAS-score for pain at movement and at rest every three hours
PCA-bolus-sum every three-hour period
Morphine-IM rescue dose every three-hour period
7 secondary outcomes
patient satisfaction each 24 hours
iv-morphine dose needed to attain VAS-score under 40 mm
PONV every three hours
urine retention every three hours
itching every three hours
decrease in saturation every three hours
quality of physical training
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 30 Mar 2007.
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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.
Sibrand Houtman, MD principal investigator
Rijnstate Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Total Hip Replacement, run by Rijnstate Hospital.
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 1 inclusion and 4 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 30 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VAS-score for pain at movement and at rest every three hours. The study lists 3 primary outcomes in all. 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 30 Mar 2007.