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Saphenous Nerve Block for Partial Meniscectomy

Primary Purpose

Pain, Joint, Pain, Procedural, Meniscectomy

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Saphenous Nerve Block
Ropivacaine injection
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Partial Meniscectomy without Saphenous Nerve Block

Partial Meniscectomy with Saphenous Nerve Block

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduced Pain Levels
This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery
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
Reduced Pain Levels
This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery

Secondary Outcome Measures

Full Information

First Posted
January 18, 2021
Last Updated
January 18, 2021
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04717609
Brief Title
Saphenous Nerve Block for Partial Meniscectomy
Official Title
Surgeon Performed Saphenous Nerve Block at the Medial Femoral Condyle for Arthroscopic Partial Meniscectomy and Meniscus Repair: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Anticipated)
Primary Completion Date
January 25, 2022 (Anticipated)
Study Completion Date
January 25, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Joint, Pain, Procedural, Meniscectomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Partial Meniscectomy without Saphenous Nerve Block
Arm Type
Active Comparator
Arm Description
Participants scheduled for partial meniscectomy will preoperatively receive 0.5% ropivacaine with epinephrine
Arm Title
Partial Meniscectomy with Saphenous Nerve Block
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Saphenous Nerve Block
Intervention Description
Preoperative Saphenous Nerve Block for partial Meniscectomy
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Intervention Description
preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine
Primary Outcome Measure Information:
Title
Reduced Pain Levels
Description
This will be measured by Participant Opioid Use will be collected everyday for 10 days after surgery
Time Frame
10 days
Title
Quality of Recovery
Description
After surgery while in the recovery room a 40 question survey will be administered regarding your comfort level, emotional state and pain
Time Frame
20 minutes
Title
Reduced Pain Levels
Description
This will be measured using the numeric rating score (NRS). It will be collected at 1 and 10 days after surgery
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Saphenous Nerve Block for Partial Meniscectomy

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