Clinical trial NCT03706313: Genicular Nerve Block for Total Knee Arthroplasty
Official title: A Comparison of Analgesic Efficacy of Ultrasound-guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: Total knee replacement
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.

Detailed description: Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.

Eligibility criteria: Inclusion Criteria:

* Subjects scheduled for primary elective total knee arthroplasty
* American Society of Anesthesiologists Physical Status I-III
* BMI 18-40 kg/m2

Exclusion Criteria:

* Inability to cooperate with protocol
* Inability to understand or speak English
* Allergy to ropivacaine, bupivacaine or other local anesthetic
* Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
* Revision knee surgery
* Chronic opioid consumption (daily morphine equivalent of \>30 mg for at least four weeks prior to surgery)
* History of chronic pain
* History of psychiatric disorder
* History of diabetes mellitus

Primary outcomes:
measure: Opioid Consumption at 24 Hours Post-op
timeFrame: 24 hours after operation
Secondary outcomes:
measure: Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
timeFrame: Postoperative Day 1
measure: Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
timeFrame: Postoperative day 1
measure: Total Opioid Consumption Through 48 Hours
timeFrame: 48 hours
measure: Opioid Consumption on Postoperative Day 7
timeFrame: Postoperative day 7
measure: Worst Pain Rating Score (NRS-11) on Postoperative Day 7
timeFrame: Postoperative day 7
measure: Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
timeFrame: Postoperative day 1
measure: Patient Satisfaction With Pain Control at 24 h
timeFrame: 24 hours
measure: Patient Satisfaction With Pain Control on Postoperative Day 7
timeFrame: Postoperative day 7
measure: 20 Meter Walk Test Time Performed on Postoperative Day 1
timeFrame: On postoperative day 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Jeffrey Gadsden, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.