Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction

NCT ID: NCT02008617

Last Updated: 2017-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2015-12-31

Brief Summary

Outpatients scheduled to have ACL surgery typically receive a femoral nerve block to provide analgesia for the front of the knee. Postoperatively, these patients will often report pain in the back of the knee. Local anesthetic infiltration of the posterior aspect of the knee results in blockade of the genicular nerves of the posterior knee. These nerves originate off of the tibial and common peroneal nerves and their blockade will result in improved posterior knee pain relief and may decrease narcotic consumption compared to patients who receive the same infiltration with normal saline.

Detailed Description

Femoral nerve blocks are commonly used to provide postoperative analgesia for ACL surgery. The limitation of these blocks is the incomplete analgesia they provide of the knee joint subjecting the patient to posterior knee pain. As a result, some of these patients receive rescue sciatic blocks in the postoperative care unit to cover posterior knee pain. The sciatic block provides excellent analgesia for the posterior knee; however its blockade invariably affects other territories of the sciatic nerve such as the lower leg and foot. For ACL surgery, the loss of sensation and/or motor strength to this area is unnecessary and may make ambulation more difficult. The ability to ambulate with minimal assistance may be more important for a patient undergoing an outpatient surgery when compared to an inpatient surgery.

At the posterior knee, the sciatic nerve branches off into the tibial and common peroneal nerves which give rise to sensory fibers that innervate the posterior knee. We propose targeting these terminal fibers in the popliteal fossa by infiltrating local anesthetic between the distal femoral shaft and popliteal artery thereby providing posterior knee analgesia without affecting the lower leg.This application of this block has not been studied in patients having ACL surgery. A single interim analysis is scheduled after the data for 50 cases are available.

Conditions

Rupture of Anterior Cruciate Ligament

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Study Drug

Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

30mL of Bupivicaine 0.20% with epinephrine 1:300,000

Preservative free normal saline

Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline

Group Type: SHAM_COMPARATOR

Preservative free normal saline

Intervention Type: DRUG

Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline

Interventions

Bupivacaine

30mL of Bupivicaine 0.20% with epinephrine 1:300,000

Intervention Type: DRUG

Preservative free normal saline

Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline

Intervention Type: DRUG

Other Intervention Names

Marcaine; 0.9% sodium chloride

Eligibility Criteria

Inclusion Criteria

1. patients who are presenting for ACL reconstruction

2. candidates for peripheral nerve blocks patients

3. ASA 1-3

Exclusion Criteria

1. Patient refusal

2. ASA Classification of 4 or higher

3. Pre-existing neuropathy in the femoral or sciatic distribution

4. Coagulopathy

5. Infection at the site

6. Non-English speaking or non-reading patients

7. Chronic opioid use (>3months)

8. Pregnancy

9. Any other contra-indication to regional anesthesia

10. Failed femoral nerve block

11. Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Rohit Rahangdale

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rohit Rahangdale, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00085894

Identifier Type: -

Identifier Source: secondary_id

STU00085894

Identifier Type: -

Identifier Source: org_study_id