Analgesia After ACL ReconstructionPhase 4FNB for ACLRNCT01593566
Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction
A Phase 4 study testing 0.25% Bupivacaine and 0.5% Bupivacaine in people with Analgesia After ACL Reconstruction, run by Mahidol University at 1 site in Thailand.
Trial summary
Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Analgesia After ACL Reconstruction
- What is being tested?
- 0.25% Bupivacaine and 0.5% Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2011to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for ACL reconstruction
- ASA physical status I-II
- Body weight > or = 50 kg.
Who cannot join
- Patients with redo ACL reconstruction
- Contraindication to neuraxial block
- allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
- Patients with communication problem
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, 10700
About this study
Official title: Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction
Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.
- Conditions
- Analgesia After ACL Reconstruction
- Being tested
- 0.25% Bupivacaine, 0.5% Bupivacaine
- Keywords
- femoral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.25% BupivacaineDrug
Also called marcaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine
0.5% BupivacaineDrug
Also called marcaine
Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| 0.25% bupivacaine | Active comparator | femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine Receives: Drug: 0.25% Bupivacaine |
| 0.5% bupivacaine | Active comparator | femoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine Receives: Drug: 0.5% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first analgesic requirement
Measured: 48 hr
Secondary outcomes (1)
pain score scale
Measured: 48 hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia After ACL ReconstructionStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, arissara iamaroon, Mahidol University
- Investigators
- arissara iamaroon, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593566
- Sponsor's protocol ID
- Mahidol University
- Acronym
- FNB for ACLR
- Status last verified
- Apr 2015
- First submitted
- 4 May 2012
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Nerve Block Using 0.25% Versus 0.5% Bupivacaine for Analgesia After Arthroscopic Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT01593566
- Acronym / sponsor ID
- FNB for ACLR / Mahidol University
- Conditions
- Analgesia After ACL Reconstruction
- Keywords
- femoral nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 8 May 2012 (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.
Femoral nerve block using 0.25% bupivacaine or 0.5% bupivacaine provides a longer time for analgesia after Anterior Cruciate Ligament (ACL) reconstruction.
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 |
|---|---|---|
| 0.25% bupivacaine | Active comparator | Drug: 0.25% Bupivacainefemoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine |
| 0.5% bupivacaine | Active comparator | Drug: 0.5% Bupivacainefemoral nerve block using 0.25% bupivacaine versus 0.5% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for ACL reconstruction
- ASA physical status I-II
- Body weight > or = 50 kg.
Key exclusion criteria (4 listed)
- Patients with redo ACL reconstruction
- Contraindication to neuraxial block
- allergy to local anesthetics, sulfa, NSAIDs, morphine, paracetamol
- Patients with communication problem
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 |
|---|---|---|
| 0.25% BupivacaineAlso: marcaineFemoral nerve block using 0.25% versus 0.5% bupivacaine | Drug | 0.25% bupivacaine |
| 0.5% BupivacaineAlso: marcaineFemoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction | Drug | 0.5% bupivacaine |
Primary outcome
time to first analgesic requirement
Time frame: 48 hr
1 secondary outcome
pain score scale
Time frame: 48 hr
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 9 Apr 2015.
Related trials for Analgesia After ACL Reconstruction
Enrolling by invitationPhase 3
Reduce Opiate Exposure With ACL Surgery
Anterior Cruciate Ligament Injuries
Active, not recruitingPhase 2
Non-Narcotic Pain Control After ACL Reconstruction
ACL - Anterior Cruciate Ligament Rupture, ACL Injuries
Not yet recruitingPhase 4
Suzetrigine Versus Usual-care Opioids for Postop Pain in Sports
Postoperative Pain Management
Not yet recruitingPhase 2
Evaluation of Pain Management After Surgery When Using Nerve Blocks in the Pediatric Population
Anterior Cruciate Ligament (ACL) Tear, Sports Injuries in Children
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.
arissara iamaroon principal investigator
Mahidol University
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 0.25% Bupivacaine and 0.5% Bupivacaine in people with Analgesia After ACL Reconstruction, 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 3 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 9 Apr 2015. 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?
time to first analgesic requirement (time frame: 48 hr). 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 9 Apr 2015.