Genicular Nerve Block for Total Knee Arthroplasty

NCT03706313 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00100879
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Pain

Keywords

Total knee replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1

  Postoperative Day 1

• Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1

  Postoperative day 1

• Total Opioid Consumption Through 48 Hours

  48 hours

• Opioid Consumption on Postoperative Day 7

  Postoperative day 7

• Worst Pain Rating Score (NRS-11) on Postoperative Day 7

  Postoperative day 7

Study Arms (2)

Genicular nerve block with bupivacaine

ACTIVE COMPARATOR

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 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: 15mL 0.25% bupivacaine; Procedure: Genicular nerve block

Genicular nerve block with saline

PLACEBO COMPARATOR

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 (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a 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.

Procedure: Genicular nerve block; Drug: Saline

Interventions

15mL 0.25% bupivacaine DRUG

Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline

Genicular nerve block with bupivacaine

Genicular nerve block PROCEDURE

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.

Genicular nerve block with bupivacaine; Genicular nerve block with saline

Saline DRUG

Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline

Genicular nerve block with saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 34261807 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jeff Gadsden
• Organization: Duke University

jeff.gadsden@duke.edu

919-681-6437

Study Officials

• Jeffrey Gadsden, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 15, 2018
• Study Start: January 15, 2019
• Primary Completion: October 16, 2019
• Study Completion: October 22, 2019
• Last Updated: April 1, 2021
• Results First Posted: November 5, 2020

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)