Genicular Nerve Block for Total Knee Arthroplasty

Post-operative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03706313
• Other study ID #: Pro00100879
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2019
• Est. completion date: October 22, 2019

Study information

• Verified date: March 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 22, 2019
• Est. primary completion date: October 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

Drug:
• 15mL 0.25% bupivacaine
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline

Procedure:
• Genicular nerve block
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.

Drug:
• Saline
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Consumption at 24 Hours Post-op	Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.	24 hours after operation
Secondary	Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1	The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.	Postoperative Day 1
Secondary	Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1	The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.	Postoperative day 1
Secondary	Total Opioid Consumption Through 48 Hours	Total of all opioids consumed converted to oral morphine equivalents.	48 hours
Secondary	Opioid Consumption on Postoperative Day 7	Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7	Postoperative day 7
Secondary	Worst Pain Rating Score (NRS-11) on Postoperative Day 7	The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.	Postoperative day 7
Secondary	Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night	The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.	Postoperative day 1
Secondary	Patient Satisfaction With Pain Control at 24 h	Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)	24 hours
Secondary	Patient Satisfaction With Pain Control on Postoperative Day 7	Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)	Postoperative day 7
Secondary	20 Meter Walk Test Time Performed on Postoperative Day 1	This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time.	On postoperative day 1