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Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength

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ClinicalTrials.gov Identifier: NCT05190120
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Tear Knee Meniscus Tear Procedure: Femoral Nerve Block Procedure: Adductor Canal Nerve Block Drug: preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine Drug: Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml. Phase 4

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, time to onset of sensory block, duration of nerve blockade, block performance time, patient satisfaction score, perioperative opioid use, perioperative analgesic consumption, incidence of paresthesias, number of needle passes, incidence of post-operative nausea, vomiting, constipation, and any other complications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Ultrasound-guided Adductor Canal Block Versus Femoral Nerve Block on Pain and Quadriceps Strength After Ambulatory Knee Arthroscopic Surgery
Study Start Date : January 2016
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : March 2022

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.
Procedure: Femoral Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy

Drug: preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine
Experimental: Adductor Canal Block
Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.
Procedure: Adductor Canal Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy

Drug: Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.



Primary Outcome Measures :
  1. 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. We are trying to measure the effect of both femoral and adductor canal nerve blocks on quadriceps strength.


Secondary Outcome Measures :
  1. Numerical Pain score from 0-10 [ Time Frame: up to 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

  2. Duration of nerve block [ Time Frame: 8 to 24 hours ]
    Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05190120


Locations
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United States, California
UCSF Orthopedic Trauma Service Recruiting
San Francisco, California, United States, 94158
Contact: Pedram Aleshi, MD       pedram.aleshi@ucsf.edu   
Principal Investigator: Pedram Aleshi, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Pedram Aleshi, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05190120    
Other Study ID Numbers: 14-13071
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared only if required for the publication of data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Knee arthroscopy
ACL reconstruction
Femoral block
Adductor Canal Block
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents