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Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength

Primary Purpose

Anterior Cruciate Ligament Tear, Knee Meniscus Tear

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
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.
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring Knee arthroscopy, ACL reconstruction, Femoral block, Adductor Canal Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCSF Orthopedic Trauma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Femoral Block

Adductor Canal Block

Arm Description

Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.

Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Duration of nerve block
Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain
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.

Full Information

First Posted
November 16, 2021
Last Updated
January 11, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05190120
Brief Title
Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength
Official Title
Effects of Ultrasound-guided Adductor Canal Block Versus Femoral Nerve Block on Pain and Quadriceps Strength After Ambulatory Knee Arthroscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
March 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear, Knee Meniscus Tear
Keywords
Knee arthroscopy, ACL reconstruction, Femoral block, Adductor Canal Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Femoral Block
Arm Type
Active Comparator
Arm Description
Patients scheduled for knee arthroscopy will have a femoral nerve block done using 0.5% ropivacaine 20ml before surgery.
Arm Title
Adductor Canal Block
Arm Type
Experimental
Arm Description
Patients scheduled for knee arthroscopy will have an adductor canal block done using 0.75% ropivacaine 13.3ml before surgery.
Intervention Type
Procedure
Intervention Name(s)
Femoral Nerve Block
Intervention Description
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
Intervention Type
Procedure
Intervention Name(s)
Adductor Canal Nerve Block
Intervention Description
Patients having ACL reconstruction, meniscus surgery and knee arthroscopy
Intervention Type
Drug
Intervention Name(s)
preoperative Femoral Nerve Block using 20ml of 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Preoperative Adductor canal block with 0.75%% ropivacaine 13.3ml.
Primary Outcome Measure Information:
Title
Change in quadriceps strength related to the nerve block
Description
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.
Time Frame
Baseline and 20 minutes after the block prior to surgery
Secondary Outcome Measure Information:
Title
Numerical Pain score from 0-10
Description
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
Time Frame
up to 24 hours
Title
Duration of nerve block
Description
Patients will be contacted after surgery to determine when the nerve block wore off based on their increase in pain
Time Frame
8 to 24 hours
Title
Opioid Consumption reported at mg of morphine equivalence
Description
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.
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedram Aleshi, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Orthopedic Trauma Service
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared only if required for the publication of data.

Learn more about this trial

Adductor Canal Block Versus Femoral Block on Pain and Quadriceps Strength

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