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

NCT02008617 | Terminated Phase 4 Results

• 1 other identifier: STU00085894
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

Anterior cruciate ligament reconstruction

Outcome Measures

Primary Outcomes (1)

• Opioid Consumption

  Opioid consumption (mg morphine equivalents)

  24 hours

Secondary Outcomes (3)

• Pain Score

  Pain Burden at 24hrs

• Patient Satisfaction

  24hr

• Quality of Recovery (QoR15)

  24hrs

Study Arms (2)

Study Drug

ACTIVE COMPARATOR

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

Drug: Bupivacaine

Preservative free normal saline

SHAM COMPARATOR

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

Drug: Preservative free normal saline

Interventions

Bupivacaine DRUG

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

Also known as: Marcaine

Study Drug

Preservative free normal saline DRUG

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

Also known as: 0.9% sodium chloride

Preservative free normal saline

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are presenting for ACL reconstruction
• candidates for peripheral nerve blocks patients
• ASA 1-3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Rohit Rahangdale, M.D.
• Organization: Northwestern University, Feinberg School of Medicine

rrahangd@nmff.org

312-695-4814

Study Officials

• Rohit Rahangdale, M.D.

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 11, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 19, 2017
• Results First Posted: April 19, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)