- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05190120
Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength
Effects of Ultrasound-guided Adductor Canal Block Versus Femoral Nerve Block on Pain and Quadriceps Strength After Ambulatory Knee Arthroscopic Surgery
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94158
- UCSF Orthopedic Trauma Service
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesia I-III classification,
- Scheduled for arthroscopic knee surgery (meniscal debridement/repair, ACL reconstruction)
Exclusion Criteria:
- 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
- Dementia
- Patient refusal
- High pre-operative opioid requirements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Femoral Block
Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.
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Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
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|
Experimental: Adductor Canal Block
Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.
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Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Quadriceps Strength Related to the Nerve Block
Time Frame: Baseline and 20 minutes after the block prior to surgery
|
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.
|
Baseline and 20 minutes after the block prior to surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Score From 0-10
Time Frame: worse pain in first 24 hours
|
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. |
worse pain in first 24 hours
|
|
Duration of Nerve Block
Time Frame: 8 to 24 hours
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Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain
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8 to 24 hours
|
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Opioid Consumption Reported at mg of Morphine Equivalence
Time Frame: 2 days
|
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.
|
2 days
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Collaborators and Investigators
Investigators
- Principal Investigator: Pedram Aleshi, MD, University of California, San Francisco
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-13071
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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