Saphenous Nerve Block for Partial Meniscectomy

Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pain, Procedural; Pain, Joint; Meniscectomy
• Intervention / Treatment: Drug: Ropivacaine injection; Procedure: Saphenous Nerve Block

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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	Drug: Ropivacaine injection; preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine; Procedure: Saphenous Nerve Block; Preoperative Saphenous Nerve Block for partial Meniscectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced Pain Levels	This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery	10 days
Quality of Recovery	After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain	20 minutes
Reduced Pain Levels	This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery	10 days

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (Anticipated): January 25, 2021
• Primary Completion (Anticipated): January 25, 2022
• Study Completion (Anticipated): January 25, 2022

Study Registration Dates

• First Submitted: January 18, 2021
• First Submitted That Met QC Criteria: January 18, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 18, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain, Procedural; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: JHOR 20D.975

Drug and device information, study documents

• 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