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

Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

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.

Study Overview

• Status: Terminated
• Conditions: Rupture of Anterior Cruciate Ligament
• Intervention / Treatment: Drug: Bupivacaine; Drug: Preservative free 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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Drug; Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)	Drug: Bupivacaine; 30mL of Bupivicaine 0.20% with epinephrine 1:300,000; Other Names: Marcaine
Sham Comparator: Preservative free normal saline; Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline	Drug: Preservative free normal saline; Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline; Other Names: 0.9% sodium chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Opioid consumption (mg morphine equivalents)	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Score	Numeric Rating Scale (NRS) (NRS pain scores; 0 = no pain,10 = excruciating pain) in the back of the knee recorded every 4 hours up to 24hrs following surgery. Pain Bruden scale ranges from 0 (no pain) to 240 (extreme pain). For example, pain burden of 120 is equivalent to a NRS score of 5 out of 10.	Pain Burden at 24hrs
Patient Satisfaction	Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).	24hr
Quality of Recovery (QoR15)	Quality of recovery (QoR15) is a questionnaire that asks 15 questions regarding how the participant has felt in the last 24 hours. Each question is followed by an 11-point numerical rating scale (0 = "none of the time" to 10 = "all of the time"; maximum score 150). The higher the QoR15 total score, the worse the quality of recovery reported.	24hrs

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Rohit Rahangdale, M.D., Northwestern University Feinberg School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Actual): April 19, 2017
• Last Update Submitted That Met QC Criteria: March 8, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Anterior cruciate ligament reconstruction
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: STU00085894

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No