A Clinical Trial of Two Periarticular Multimodal Drug Injections in Total Hip and Knee Arthroplasty

NCT02543801 | Completed Phase 4 Results

• 1 other identifier: IRB2022
• Study Type: interventional
• Target: 239
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates two routinely used drug combinations for periarticular injection following total hip and knee arthroplasty for pain control. One group will receive liposomal bupivacaine, bupivacaine, clonidine, epinephrine and ketorolac. The other group will receive ropivacaine, clonidine, epinephrine and ketorolac.

Conditions

Total Hip and Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Self-reported pain score 0-10 (0=no pain - 10=worst possible pain experienced) and higher scores indicate a worse outcome Pain scores, collected every 4 hours per hospital care standards, were averaged (post-operatively up to 48 hours) to obtain individual mean pain scores and a mean score for the group was then calculated.

  Starting post operatively and then every four hours up to 48 hours

Secondary Outcomes (2)

• Narcotic Consumption

  Starting immediately post operatively up to 48 hours

• Length of Stay

  Start of surgery to hospital discharge up to 140 hours

Study Arms (4)

Hip Cohort Liposomal Bupivacaine

ACTIVE COMPARATOR

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine

Hip Cohort Ropivacaine

ACTIVE COMPARATOR

Ropivacaine Clonidine Epinephrine Ketorolac

Drug: Ropivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine

Knee Cohort Liposomal Bupivacaine

ACTIVE COMPARATOR

Liposomal bupivacaine Bupivacaine Clonidine Epinephrine Ketorolac

Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine

Knee Cohort Ropivacaine

ACTIVE COMPARATOR

Ropivacaine Clonidine Epinephrine Ketorolac

Drug: Ropivacaine; Drug: Clonidine; Drug: Ketorolac; Drug: Epinephrine

Interventions

Liposomal Bupivacaine DRUG

Periarticular injection

Also known as: Exparel

Hip Cohort Liposomal Bupivacaine; Knee Cohort Liposomal Bupivacaine

Ropivacaine DRUG

Periarticular injection

Also known as: Naropin

Hip Cohort Ropivacaine; Knee Cohort Ropivacaine

Bupivacaine DRUG

Included as an element of the Liposomal bupivacaine intervention periarticular injection

Also known as: Marcaine

Hip Cohort Liposomal Bupivacaine; Knee Cohort Liposomal Bupivacaine

Clonidine DRUG

Included as an element of both interventions as a standard of care periarticular injection

Also known as: Duraclon

Hip Cohort Liposomal Bupivacaine; Hip Cohort Ropivacaine; Knee Cohort Liposomal Bupivacaine; Knee Cohort Ropivacaine

Ketorolac DRUG

Included as an element of both interventions as a standard of care periarticular injection

Also known as: Toradol

Hip Cohort Liposomal Bupivacaine; Hip Cohort Ropivacaine; Knee Cohort Liposomal Bupivacaine; Knee Cohort Ropivacaine

Epinephrine DRUG

Included as an element of both interventions as a standard of care periarticular injection

Also known as: Adrenaline

Hip Cohort Liposomal Bupivacaine; Hip Cohort Ropivacaine; Knee Cohort Liposomal Bupivacaine; Knee Cohort Ropivacaine

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hip Arthritis (osteoarthritis, post traumatic, inflammatory, and avascular necrosis)

You may not qualify if:

• Current use of opioid drugs
• Revision surgery
• Surgical complication (femoral fracture with implant insertion)
• Inability to provide Informed Consent

Sponsors & Collaborators

• Kootenai Health: lead

MeSH Terms

Interventions

Ropivacaine; Bupivacaine; Clonidine; Ketorolac; Ketorolac Tromethamine; Epinephrine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Anesthesia (general or spinal) followed patient preference and not dictated by protocol.

Results Point of Contact

• Title: Director of Research Programs
• Organization: Kootenai Health

salbritton@kh.org

2086254223

Study Officials

• Joe Bowen, MD

  Kootenai Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2015
• First Posted: September 7, 2015
• Study Start: January 25, 2016
• Primary Completion: August 21, 2018
• Study Completion: August 21, 2018
• Last Updated: October 18, 2019
• Results First Posted: October 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share