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

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Preservative free normal saline
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rupture of Anterior Cruciate Ligament focused on measuring Anterior cruciate ligament reconstruction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Study Drug

Preservative free normal saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Opioid Consumption
Opioid consumption (mg morphine equivalents)

Secondary Outcome Measures

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.
Patient Satisfaction
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
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.

Full Information

First Posted
December 6, 2013
Last Updated
March 8, 2017
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02008617
Brief Title
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing ACL Reconstruction
Official Title
Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to lack of subject recruitment
Study Start Date
December 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
Anterior cruciate ligament reconstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study Drug
Arm Type
Active Comparator
Arm Description
Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000 (Study Drug)
Arm Title
Preservative free normal saline
Arm Type
Sham Comparator
Arm Description
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Marcaine
Intervention Description
30mL of Bupivicaine 0.20% with epinephrine 1:300,000
Intervention Type
Drug
Intervention Name(s)
Preservative free normal saline
Other Intervention Name(s)
0.9% sodium chloride
Intervention Description
Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Opioid consumption (mg morphine equivalents)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Pain Score
Description
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.
Time Frame
Pain Burden at 24hrs
Title
Patient Satisfaction
Description
Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).
Time Frame
24hr
Title
Quality of Recovery (QoR15)
Description
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.
Time Frame
24hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients who are presenting for ACL reconstruction candidates for peripheral nerve blocks patients ASA 1-3 Exclusion Criteria: Patient refusal ASA Classification of 4 or higher Pre-existing neuropathy in the femoral or sciatic distribution Coagulopathy Infection at the site Non-English speaking or non-reading patients Chronic opioid use (>3months) Pregnancy Any other contra-indication to regional anesthesia Failed femoral nerve block Sciatic nerve block placed due to severe pain not managed by intravenous and oral agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rohit Rahangdale, M.D.
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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