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

This study has been terminated.
(The study was terminated due to lack of subject recruitment)
Sponsor:
Information provided by (Responsible Party):
Rohit Rahangdale, Northwestern University
ClinicalTrials.gov Identifier:
NCT02008617
First received: December 6, 2013
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Rupture of Anterior Cruciate Ligament Drug: Bupivacaine Drug: Preservative free normal saline Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Analgesic Benefits of Genicular Nerve Blocks of the Posterior Knee for Patients Undergoing Anterior Cruciate Ligament (ACL) Reconstruction

Resource links provided by NLM:


Further study details as provided by Rohit Rahangdale, Northwestern University:

Primary Outcome Measures:
  • Opioid Consumption [ Time Frame: 24 hours ]
    Opioid consumption (mg morphine equivalents)


Secondary Outcome Measures:
  • Pain Score [ Time Frame: Pain Burden at 24hrs ]
    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 [ Time Frame: 24hr ]
    Patient satisfaction with pain control scale ranges from 0 (no satisfaction) to 10 (very satisfied).

  • Quality of Recovery (QoR15) [ Time Frame: 24hrs ]
    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.


Enrollment: 18
Actual Study Start Date: December 2013
Study Completion Date: December 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 0.9% sodium chloride

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008617

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Rohit Rahangdale, M.D. Northwestern University Feinberg School of Medicine
  More Information

Responsible Party: Rohit Rahangdale, Assistant Professor of Anesthesiology, Northwestern University
ClinicalTrials.gov Identifier: NCT02008617     History of Changes
Other Study ID Numbers: STU00085894
Study First Received: December 6, 2013
Results First Received: March 8, 2017
Last Updated: March 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rohit Rahangdale, Northwestern University:
Anterior cruciate ligament reconstruction

Additional relevant MeSH terms:
Rupture
Wounds and Injuries
Bupivacaine
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 18, 2017