Saphenous Nerve Block for Partial Meniscectomy

NCT04717609 | Unknown Phase 3 FDA Drug

• 1 other identifier: JHOR 20D.975
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Joint; Pain, Procedural; Meniscectomy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Partial Meniscectomy without Saphenous Nerve Block

ACTIVE COMPARATOR

Participants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine

Drug: Ropivacaine injection

Partial Meniscectomy with Saphenous Nerve Block

EXPERIMENTAL

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; Drug: Ropivacaine injection

Interventions

Saphenous Nerve Block PROCEDURE

Preoperative Saphenous Nerve Block for partial Meniscectomy

Partial Meniscectomy with Saphenous Nerve Block

Ropivacaine injection DRUG

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

Partial Meniscectomy with Saphenous Nerve Block; Partial Meniscectomy without Saphenous Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Arthralgia; Pain, Procedural

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: January 22, 2021
• Study Start: January 25, 2021
• Primary Completion: January 25, 2022
• Study Completion: January 25, 2022
• Last Updated: January 22, 2021

Record last verified: 2021-01

Locations

US (1)