Anterior Cruciate Ligament TearNCT01447277
Prospective Femoral Versus Femoral and Sciatic Nerve Block for Anterior Cruciate Ligament (ACL) Reconstruction
A study testing Sciatic Block and Femoral Block only in people with Anterior Cruciate Ligament Tear, run by University of California, San Francisco at 1 site in United States.
Trial summary
The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Tear
- What is being tested?
- Sciatic Block and Femoral Block only
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Jun 2013
- 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
- Age 18 and over
- ASA status I-II
- Scheduled for ambulatory Arthroscopic ACL Surgery
Who cannot join
- Allergy to Local anesthetics or opiates used in the study
- Contraindications for regional anesthesia
- coagulopathy, anticoagulation, Thrombocytopenia
- infection at site of injection
- Chronic pain and high preoperative opiate requirements
- High risk for PONV
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopedic Institute
San Francisco, California, 94158
About this study
Official title: The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.
Read the detailed description
Although femoral nerve blocks improve analgesia after anterior cruciate ligament (ACL) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. In a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory ACL reconstruction. We hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter PACU length of stay and improved patient satisfaction.
- Conditions
- Anterior Cruciate Ligament Tear
- Being tested
- Sciatic Block, Femoral Block only
- Keywords
- ACL reconstruction, Femoral Block, Sciatic Block
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sciatic BlockProcedure or surgery
Performing a sciatic block in addition to a femoral block preoperatively
Femoral Block onlyProcedure or surgery
Performing a preoperative sciatic nerve block only
| Study group | Role | What they receive |
|---|---|---|
| Femoral and Sciatic Block | Experimental | Administration of preoperative femoral and sciatic nerve blocks Receives: Procedure: Sciatic Block |
| Femoral Block Only | Other | Administration of a femoral nerve block prior to surgery Receives: Procedure: Femoral Block only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Measured: PACU and POD1, 2 and 3.
Secondary outcomes (3)
Length of stay
Measured: Duration of stay in the recovery room
Opiate consumption
Measured: During surgery, recovery room and for 3 days after discharge
PONV
Measured: During the recovery room stay and after discharge from surgery center for up to 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionMay 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 Anterior Cruciate Ligament TearStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447277
- Sponsor's protocol ID
- 11-06776
- Status last verified
- Feb 2020
- First submitted
- 30 Sep 2011
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of a Preoperative Sciatic Nerve Block to a Femoral Nerve Block for Ambulatory Arthroscopic ACL Reconstruction
- ClinicalTrials.gov ID
- NCT01447277
- Acronym / sponsor ID
- 11-06776
- Conditions
- Anterior Cruciate Ligament Tear
- Keywords
- ACL reconstruction, Femoral Block, Sciatic Block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 6 Oct 2011 (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.
The investigators propose that a preoperative femoral and sciatic blocks vs a femoral block only, prior to ambulatory anterior cruciate ligament (ACL) reconstruction will lead to a decrease in opiate consumption, pain scores, and post-anesthesia care unit (PACU) length of stay. The investigators are prospectively randomizing patients to either a femoral or a fem/sciatic block and monitor outcomes.
Detailed description
Although femoral nerve blocks improve analgesia after anterior cruciate ligament (ACL) reconstruction, patients often complain of posterior knee pain, which can be treated with a sciatic nerve block. In a prospective randomized study, we compare preoperative femoral nerve block to a combined femoral and sciatic block in patients undergoing ambulatory ACL reconstruction. We hypothesize that the combined femoral/sciatic nerve block patients would have improved analgesia, fewer opioid-related side effects, and shorter PACU length of stay and improved patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral and Sciatic Block | Experimental | Procedure: Sciatic BlockAdministration of preoperative femoral and sciatic nerve blocks |
| Femoral Block Only | Other | Procedure: Femoral Block onlyAdministration of a femoral nerve block prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and over
- ASA status I-II
- Scheduled for ambulatory Arthroscopic ACL Surgery
Key exclusion criteria (6 listed)
- Allergy to Local anesthetics or opiates used in the study
- Contraindications for regional anesthesia
- coagulopathy, anticoagulation, Thrombocytopenia
- infection at site of injection
- Chronic pain and high preoperative opiate requirements
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 |
|---|---|---|
| Sciatic BlockPerforming a sciatic block in addition to a femoral block preoperatively | Procedure or surgery | Femoral and Sciatic Block |
| Femoral Block onlyPerforming a preoperative sciatic nerve block only | Procedure or surgery | Femoral Block Only |
Primary outcome
Pain Scores
Time frame: PACU and POD1, 2 and 3.
3 secondary outcomes
Length of stay
Time frame: Duration of stay in the recovery room
Opiate consumption
Time frame: During surgery, recovery room and for 3 days after discharge
PONV
Time frame: During the recovery room stay and after discharge from surgery center for up to 3 days.
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 21 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sciatic Block and Femoral Block only in people with Anterior Cruciate Ligament Tear, run by University of California, San Francisco at 1 site in United States.
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 6 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 21 Feb 2020. 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 United States. 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.
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 Scores (time frame: PACU and POD1, 2 and 3.). 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 21 Feb 2020.