Saphenous Nerve Block for Partial Meniscectomy

Pain, Procedural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04717609
• Other study ID #: JHOR 20D.975
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: January 25, 2021
• Est. completion date: January 25, 2022

Study information

• Verified date: January 2021
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: January 25, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Meniscectomy
• Pain, Joint
• Pain, Procedural

Intervention

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

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced Pain Levels	This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery	10 days
Primary	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
Primary	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