Post Operative PainPhase 4NCT00795223
Comparative Pain Control Between 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for FNB After TKA
A Phase 4 study testing morphine and bupivacaine and spinal morphine and marcaine in people with Post Operative Pain and Total Knee Replacement, run by Mahidol University at 1 site in Thailand.
Trial summary
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Post Operative Pain, Total Knee Replacement
- What is being tested?
- morphine and bupivacaine and spinal morphine and marcaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2008to May 2009
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation
Who cannot join
- patient at risk in usage COX-2 for post operative pain control
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block
- Conditions
- Post Operative Pain, Total Knee Replacement
- Being tested
- morphine and bupivacaine, spinal morphine and marcaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morphine and bupivacaineDrug
Also called marcaine
0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block
spinal morphine and marcaineDrug
Also called marcaine
0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block
morphine and bupivacaineDrug
Also called marcaine
0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block
morphine and bupivacaineDrug
Also called marcaine
0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine Receives: Drug: morphine and bupivacaine |
| 2 | Active comparator | Injection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine Receives: Drug: spinal morphine and marcaine |
| 3 | Active comparator | Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine Receives: Drug: morphine and bupivacaine |
| 4 | Active comparator | Injection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine Receives: Drug: morphine and bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global assessment in post operative pain control
Measured: Begining of first enrollment in december 2008
Secondary outcomes (1)
Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS
Measured: first enrollment in December 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Collaborators
- Siriraj Hospital
- Investigators
- Thitima Chinachoti, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795223
- Sponsor's protocol ID
- 461/2551(EC1)
- Other IDs
- Grant by the siriraj Hospital
- Status last verified
- Sep 2009
- First submitted
- 20 Nov 2008
- Last updated
- 29 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effect of 0.2 or 0.3 Spinal Morphine and 0.25 or 0.5 % Bupivacaine for Femoral Nerve Block After Total Knee Replacement
- ClinicalTrials.gov ID
- NCT00795223
- Acronym / sponsor ID
- 461/2551(EC1)
- Conditions
- Post Operative Pain, Total Knee Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Collaborators
- Siriraj Hospital
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 21 Nov 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.
Comparative efficacy of 24 and 48 hours post operative pain control in single total knee replacement between intrathecal bupivacaine with 0.2 or 0.3 mg morphine together with 0.25 or 0.5 % bupivacaine for single femoral nerve block
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: morphine and bupivacaineInjection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine |
| 2 | Active comparator | Drug: spinal morphine and marcaineInjection of 0.3 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine |
| 3 | Active comparator | Drug: morphine and bupivacaineInjection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.5% bupivacaine |
| 4 | Active comparator | Drug: morphine and bupivacaineInjection of 0.2 mg morphine with spinal block and perform femoral nerve block with 0.25% bupivacaine |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Single elective total knee replacement in ASA 1-3 without significant cardiovascular limitation
Key exclusion criteria (1 listed)
- patient at risk in usage COX-2 for post operative pain control
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 |
|---|---|---|
| morphine and bupivacaineAlso: marcaine0.3 mg morphine for spinal together with 0.5% bupivacaine for femoral nerve block | Drug | 1 |
| spinal morphine and marcaineAlso: marcaine0.3 mg spinal morphine together with 0.25% bupivacaine for femoral nerve block | Drug | 2 |
| morphine and bupivacaineAlso: marcaine0.2 mg morphine for spinal 0.5% bupivacaine for femoral nerve block | Drug | 3 |
| morphine and bupivacaineAlso: marcaine0.2 mg morphine for spinal together with 0.25% bupivacaine for femoral nerve block | Drug | 4 |
Primary outcome
Global assessment in post operative pain control
Time frame: Begining of first enrollment in december 2008
1 secondary outcome
Global assessment of post operative pain in 48 HOURS AND SIDE EFFECTS
Time frame: first enrollment in December 2008
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 Sep 2009.
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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.
Thitima Chinachoti, MD principal investigator
Siriraj Hospital
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 morphine and bupivacaine and spinal morphine and marcaine in people with Post Operative Pain and Total Knee Replacement, run by Mahidol University at 1 site in Thailand.
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 1 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 Sep 2009. 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 Thailand. 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?
Global assessment in post operative pain control (time frame: Begining of first enrollment in december 2008). 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 Sep 2009.