Saphenous Nerve Block for Partial Meniscectomy

NCT ID: NCT04717609

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2022-01-25

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Partial Meniscectomy without Saphenous Nerve Block

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine injection

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Saphenous Nerve Block

Intervention Type: PROCEDURE

Preoperative Saphenous Nerve Block for partial Meniscectomy

Ropivacaine injection

Intervention Type: DRUG

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

Interventions

Saphenous Nerve Block

Preoperative Saphenous Nerve Block for partial Meniscectomy

Intervention Type: PROCEDURE

Ropivacaine injection

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

JHOR 20D.975

Identifier Type: -

Identifier Source: org_study_id