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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05190120
Other study ID # 14-13071
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 2016
Est. completion date March 20, 2022

Study information

Verified date January 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date March 20, 2022
Est. primary completion date March 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Femoral Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
Adductor Canal Nerve Block
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
Drug:
preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine

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


Locations

Country Name City State
United States UCSF Orthopedic Trauma Service San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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 up to 24 hours
Secondary Duration of nerve block Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain 8 to 24 hours
Secondary 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. 2 days
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