Anterior Cruciate Ligament TearPhase 4NCT05190120
Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength
A Phase 4 study testing Femoral Nerve Block, Adductor Canal Nerve Block and preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine in people with Anterior Cruciate Ligament Tear and Knee Meniscus Tear, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Tear, Knee Meniscus Tear
- What is being tested?
- Femoral Nerve Block, Adductor Canal Nerve Block and preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 20 Mar 2022
- Phase
- Phase 4
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
- American Society of Anesthesia I-III classification,
- Scheduled for arthroscopic knee surgery (meniscal debridement/repair, ACL reconstruction)
Who cannot join
- Age younger than 18 years
- Non-English speaking
- Any contraindication for regional anesthesia, such as allergy to local anesthetics or opioids, -Coagulopaty or severe thrombocytopenia
- Infection at puncture sites
- Pre-existing neuropathy in operative limb
- Need for post-operative nerve function monitoring
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- Dementia
- Patient refusal
- High pre-operative opioid requirements
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Orthopedic Trauma Service
San Francisco, California, 94158
About this study
Official title: Effects of Ultrasound-guided Adductor Canal Block Versus Femoral Nerve Block on Pain and Quadriceps Strength After Ambulatory Knee Arthroscopic Surgery
The purpose of this study is to compare the effects of a femoral nerve block vs. an adductor canal block on pain and quadriceps muscle strength for knee arthroscopy surgery.
Read the detailed description
Patients undergoing arthroscopic knee surgery (ACL and non-ACL surgery) typically receive an ultrasound-guided femoral nerve block or an adductor canal block in the pre-operative phase for post-operative pain control. While an effective method for post-operative analgesia, the femoral nerve block is associated with profound quadriceps weakness for the duration of the nerve block, which can impair ambulation, rehabilitation, and increase the risk of falls. The more distal adductor canal block, however, contains primarily sensory branches of the femoral nerve and has been been purported by small volunteer studies to provide equally effective analgesia with minimal motor block and quadriceps weakness (as compared to femoral nerve block).
The investigators will prospectively randomize patients undergoing knee arthroscopy at the UCSF Orthopaedic Institute to receive either a single-shot femoral nerve or adductor canal block pre-operatively after taking baseline measurements of quadriceps strength (quantified by maximum voluntary isometric contraction). The quadriceps muscle strength will be checked 20 minutes after the nerve block to assess strength. All patients will subsequently undergo a general anesthetic. The primary outcome variable will be post-block quadriceps strength as a percentage of baseline from pre-block values. Secondary outcome variables that will also investigated include: VAS pain score in the post anesthesia recovery unit and post-operative day 1, duration of nerve blockade, and perioperative opioid consumption.
- Being tested
- Femoral Nerve Block, Adductor Canal Nerve Block, preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine, Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.
- Keywords
- Knee arthroscopy, ACL reconstruction, Femoral block, Adductor Canal 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.
Femoral Nerve BlockProcedure or surgery
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
Adductor Canal Nerve BlockProcedure or surgery
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaineDrug
Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.Drug
| Study group | Role | What they receive |
|---|---|---|
| Femoral Block | Active comparator | Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery. Receives: Procedure: Femoral Nerve Block; Drug: preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine |
| Adductor Canal Block | Experimental | Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery. Receives: Procedure: Adductor Canal Nerve Block; Drug: Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps Strength Related to the Nerve Block
Quadriceps strength will be tested with a dynamometer before the nerve block and 20 minutes after the nerve block prior to surgery. The dynamometer measures the strength of the quadriceps muscles in the seated position while pushing against the device. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength.
Measured: Baseline and 20 minutes after the block prior to surgery
Secondary outcomes (3)
Numerical Pain Score From 0-10
As this is an outpatient surgery, we will collect Numerical Pain Scores from the recovery room medical record after surgery as well as from the patients for the first 24 hours after surgery by contacting them at home the following day. We will evaluate the difference in patient pain scores between the two nerve blocks under study.
The highest pain score for the 24-hour post-op period was collected for each participant. The median is reported for all participants. A pain score of 10 represents the worst pain.
Measured: worse pain in first 24 hours
Duration of Nerve Block
Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain
Measured: 8 to 24 hours
Opioid Consumption Reported at mg of Morphine Equivalence
Data on the amount of pain medication consumed for the 1st 24 hours after surgery will be collected based on medications that were administered during surgery, in the recovery room and medications that patients took at home after discharge from the recovery room. All pain medications will be converted to morphine equivalence in milligrams and reported that way. The comparison will be the difference in mg morphine equivalence consumption between the two nerve block groups.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study startJan 2016
- Primary completion20 Mar 2022
- Study completion20 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pedram Aleshi, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190120
- Sponsor's protocol ID
- 14-13071
- Status last verified
- Sep 2025
- First submitted
- 16 Nov 2021
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared only if required for the publication of data.