Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Saphenous Nerve Block for Partial Meniscectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04717609
Recruitment Status : Enrolling by invitation
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
Partial meniscectomy and meniscus repair are two of the most common orthopedic surgery procedures. As these procedures are being increasingly performed in ambulatory surgical centers, there has been a shift towards providing improved analgesia to ensure timely discharge, as well as preventing unwanted pain and side effects. As such, it has become common practice to use an intra-articular injection of local anesthetic to achieve post-operative pain control. However, these effects are short lived, requiring a multimodal approach to analgesia. To date, no optimal pain control strategy has been described for arthroscopic partial meniscectomy or meniscus repair. The purpose of this study is to examine the outcomes of subcutaneous saphenous nerve block with 0.5% ropivacaine at the medial femoral epicondyle/adductor hiatus plus portal 0.5% ropivacaine injection vs portal 0.5% ropivacaine injection alone for patients undergoing arthroscopic partial meniscectomy or meniscus repair.

Condition or disease Intervention/treatment Phase
Pain, Joint Pain, Procedural Meniscectomy Procedure: Saphenous Nerve Block Drug: Ropivacaine injection Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial
Estimated Study Start Date : January 25, 2021
Estimated Primary Completion Date : January 25, 2022
Estimated Study Completion Date : January 25, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Partial Meniscectomy without Saphenous Nerve Block
Participants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine
Drug: Ropivacaine injection
preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine

Experimental: Partial Meniscectomy with Saphenous Nerve Block
Participants scheduled for a partial meniscectomy will preoperatively receive a saphenous nerve block at the medial femoral condyle in addition to an injection of 0.5% ropivacaine with epinephrine
Procedure: Saphenous Nerve Block
Preoperative Saphenous Nerve Block for partial Meniscectomy

Drug: Ropivacaine injection
preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine




Primary Outcome Measures :
  1. Reduced Pain Levels [ Time Frame: 10 days ]
    This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery

  2. Quality of Recovery [ Time Frame: 20 minutes ]
    After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain

  3. Reduced Pain Levels [ Time Frame: 10 days ]
    This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Scheduled for arthroscopic meniscectomy or meniscus repair

Exclusion Criteria:

  • Multiple-ligament injury
  • Primary ACL reconstruction or ACL revision reconstruction
  • Articular cartilage restoration surgery
  • Evidence of microfracture
  • History of allergy to local anesthetics
  • Pre-existing saphenous neuropathy
  • Unable to be prescribed opioids due to allergy or other reason

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): NCT04717609


Locations
Layout table for location information
United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04717609    
Other Study ID Numbers: JHOR 20D.975
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthralgia
Pain, Procedural
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents