Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the KneeNCT02071433
Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
A study testing Saphenous nerve blockade and Femoral nerve blockade in people with Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee
- What is being tested?
- Saphenous nerve blockade and Femoral nerve blockade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Dec 2017
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-65 years
- ASA status I - III
- rupture of the anterior cruciate ligament.
Who cannot join
- contraindication for regional anesthesia
- allergy against local anesthetics
- BMI > 35
- pre-existing diagnosed neuropathy of the operated leg
- ingestion of strong opioids
- pregnancy or breastfeeding status
- History of significant cardiovascular disease (MI, CVA, peripheral vascular disease)
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Academic Medical Centre Amsterdam
Amsterdam, 1105 AZ
M.W. Hollmanm, m.w.hollmann@amc.uva.nl
Werner ten Hoope, MD
About this study
The purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.
- Being tested
- Saphenous nerve blockade, Femoral nerve blockade
- Keywords
- Saphenous nerve block, Adductor canal block, Anterior cruciate ligament, Pain management, Day care
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saphenous nerve blockadeProcedure or surgery
Femoral nerve blockadeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Saphenous nerve blockade | Experimental | Experimental treatment 15 mL of levobupivacaine 0.5% Receives: Procedure: Saphenous nerve blockade |
| Femoral nerve blockade | Active comparator | Standard treatment 15 mL of levobupivacaine 0.5% Receives: Procedure: Femoral nerve blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[
Measured: 1 day
Secondary outcomes (8)
Motor block
Measured: 2 days
Pain (VAS)
Measured: 2 days
Sensory blockade extent
Measured: 1 Day
Time to rescue analgesic and post operative opioid consumption
Measured: 1 Day
Overall Benefit of Analgesia Score (OBAS)
Measured: 6 weeks
SF-12 score
Measured: 12 weeks
KOOS-score
Measured: 12 weeks
IKDC-score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the KneeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W ten Hoope, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02071433
- Sponsor's protocol ID
- ACLS
- Status last verified
- Jan 2017
- First submitted
- 24 Feb 2014
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Saphenous Nerve Blockade for Outpatient Knee Anterior Cruciate Ligament Surgery
- ClinicalTrials.gov ID
- NCT02071433
- Acronym / sponsor ID
- ACLS
- Keywords
- Saphenous nerve block, Adductor canal block, Anterior cruciate ligament, Pain management, Day care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 25 Feb 2014 (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 purpose of this study is to determine whether blockade of the saphenous nerve can provide the same degree of analgesia postoperatively for ACLS as a femoral nerve block without resulting motor blockade enhancing shortening of hospital stay en functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saphenous nerve blockade | Experimental | Procedure: Saphenous nerve blockadeExperimental treatment 15 mL of levobupivacaine 0.5% |
| Femoral nerve blockade | Active comparator | Procedure: Femoral nerve blockadeStandard treatment 15 mL of levobupivacaine 0.5% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 18-65 years
- ASA status I - III
- rupture of the anterior cruciate ligament.
Key exclusion criteria (7 listed)
- contraindication for regional anesthesia
- allergy against local anesthetics
- BMI > 35
- pre-existing diagnosed neuropathy of the operated leg
- ingestion of strong opioids
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 |
|---|---|---|
| Saphenous nerve blockade | Procedure or surgery | Saphenous nerve blockade |
| Femoral nerve blockade | Procedure or surgery | Femoral nerve blockade |
Primary outcome
Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[
Time frame: 1 day
8 secondary outcomes
Motor block
Time frame: 2 days
Pain (VAS)
Time frame: 2 days
Sensory blockade extent
Time frame: 1 Day
Time to rescue analgesic and post operative opioid consumption
Time frame: 1 Day
Overall Benefit of Analgesia Score (OBAS)
Time frame: 6 weeks
SF-12 score
Time frame: 12 weeks
KOOS-score
Time frame: 12 weeks
IKDC-score
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saphenous nerve blockade and Femoral nerve blockade in people with Postoperative Analgesia for Anterior Cruciate Ligament Surgery of the Knee, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 7 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: status not confirmed, as of the sponsor's last update on 26 Jan 2017. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Werner ten Hoope, MD (0031-205663633, w.tenhoope@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness to discharge from day-care center in hours according to Post-Anesthetic Discharge Scoring System (PADSS).[ (time frame: 1 day). 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 26 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.