Pain, PostoperativeNCT00695045
Intrathecal Morphine in Knee Arthroplasty
A study testing intra thecal morphine in people with Pain, Postoperative and Arthroplasty, Replacement, Knee, run by University College Hospital Galway.
Trial summary
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Arthroplasty, Replacement, Knee
- What is being tested?
- intra thecal morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Apr 2007
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients for elective total knee arthroplasty
Who cannot join
- No contraindication to spinal
- No allergy to morphine, rescue analgesia or anti-emesis treatment.
About this study
Official title: Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.
- Being tested
- intra thecal morphine
- Keywords
- Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra thecal morphineDrug
Also called intraspinal morphine
100 mcg intrathecal morphine given once .
intra thecal morphineDrug
Also called intra spinal morphine
200 mcg intrathecal morphine given once
intra thecal morphineDrug
Also called intra spinal morphine
300 mcg intrathecal morphine given once
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | patients in this group got 100mcg of intrathecal morphine. Receives: Drug: intra thecal morphine |
| 2 | Experimental | patients in this group got 200 mcg intrathecal morphine Receives: Drug: intra thecal morphine |
| 3 | Experimental | patients in this group given 300 mcg intrathecal morphine. Receives: Drug: intra thecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Measured: 24 hours
Secondary outcomes (3)
nausea and vomiting
Measured: 24 hours
pruritus
Measured: 24 hours
sedation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startJul 2003
- Primary completionJan 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Hospital Galway
- Sponsor type
- University, hospital or other
- Investigators
- Patrick D Hassett, MD, Principal investigator, Department of Anaesthesia, UCHGJohn Laffey, MD, Study chair, Department of Anaesthesia,UCHGBrian Kinirons, MD, Study director, Dept of Anaesthesia , UCHG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00695045
- Sponsor's protocol ID
- 0001
- Status last verified
- Jun 2008
- First submitted
- 9 Jun 2008
- Last updated
- 11 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
PubMed 18816386
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Efficacy and Side-Effect Profile of Lower Doses of Intrathecal Morphine in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00695045
- Acronym / sponsor ID
- 0001
- Keywords
- Pain, Postoperative, Arthroplasty, Replacement, Knee, Morphine, Injections, Intrathecal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University College Hospital GalwayUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Jan 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 11 Jun 2008 (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.
This study is designed to explore the efficacy lower doses of intra-spinal morphine for pain relief and side effect profiles of same in the setting of Total Knee Replacement.We hypothesized that a dose greater than that used in Total Hip Replacement was needed and wished to find a dose which was effective but had a low side effect profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: intra thecal morphinepatients in this group got 100mcg of intrathecal morphine. |
| 2 | Experimental | Drug: intra thecal morphinepatients in this group got 200 mcg intrathecal morphine |
| 3 | Experimental | Drug: intra thecal morphinepatients in this group given 300 mcg intrathecal morphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients for elective total knee arthroplasty
Key exclusion criteria (2 listed)
- No contraindication to spinal
- No allergy to morphine, rescue analgesia or anti-emesis treatment.
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 |
|---|---|---|
| intra thecal morphineAlso: intraspinal morphine100 mcg intrathecal morphine given once . | Drug | 1 |
| intra thecal morphineAlso: intra spinal morphine200 mcg intrathecal morphine given once | Drug | 2 |
| intra thecal morphineAlso: intra spinal morphine300 mcg intrathecal morphine given once | Drug | 3 |
Primary outcome
pain
Time frame: 24 hours
3 secondary outcomes
nausea and vomiting
Time frame: 24 hours
pruritus
Time frame: 24 hours
sedation
Time frame: 24 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 11 Jun 2008.
- Derived from this study: PubMed 18816386Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
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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.
Patrick D Hassett, MD principal investigator
Department of Anaesthesia, UCHG
John Laffey, MD study chair
Department of Anaesthesia,UCHG
Brian Kinirons, MD study director
Dept of Anaesthesia , UCHG
Questions about this trial
What is this clinical trial studying?
A study testing intra thecal morphine in people with Pain, Postoperative and Arthroplasty, Replacement, Knee, run by University College Hospital Galway.
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 2 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 11 Jun 2008. 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.
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 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00695045, which also lists 1 linked publication.
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 11 Jun 2008.