Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

NCT02570503 | Terminated Phase 4 Results DMC

• 1 other identifier: HM20004125
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the use of a local injection around the knee (periarticular) during total knee replacement (TKR) surgery to see if it reduces postoperative pain levels. The injection is a combination of various medications which are thought to reduce pain levels. Approximately 128 patients will participate in this study, half of the patients will receive this injection during surgery and the other half will receive a saline (salt water) injection. Pain scores after the surgery will be compared between the two groups. All patients will also receive a long-acting (24 hours) morphine injection during surgery. The hypothesis is that those participants receiving intrathecal Duramorph and local periarticular injections will have improved pain scores and reduced narcotic use when compared with intrathecal Duramorph alone at 48 hours postoperatively.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (2)

• Universal Pain Assessment Tool (UPAT)

  Patient's pain scores will be measured with the UPAT scale which ranges from 0 (no pain) to 10 (severe pain) This is measured hourly while the patient is awake after the surgery.

  3 days after surgery

• Narcotic Use During Hospitalization

  The amount of narcotic pain medication needed for patient to be comfortable. This is measured in morphine equivalents since there are many pain medications other than morphine.

  0-24 hours post surgery period, 24 - 48 hours post surgery period, and Full 48 hours post surgery period

Secondary Outcomes (3)

• Patient's Subjective Rating of Pain

  3 days after surgery

• UPAT Score Before and After Physical Therapy

  3 days after surgery

• Ambulation During Physical Therapy

  48 hours after surgery

Study Arms (2)

ROP/KET/CLON/EPI/SAL

EXPERIMENTAL

Ropivacaine (ROP) (5mg/ml)- 50ml Ketorolac (KET) (30mg/ml)- 1ml Clonidine (CLON) (0.1mg/ml)- 0.8ml Epinephrine (EPI) (1mg/ml)- 0.5ml 0.9% sodium chloride SAL)--47.7 ml

Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine; Drug: Epinephrine; Drug: 0.9% sodium chloride

Placebo

PLACEBO COMPARATOR

0.9% Sodium Chloride- 100ml

Drug: 0.9% sodium chloride

Interventions

Ropivacaine DRUG

Ropivacaine (5mg/ml)-50ml

Also known as: periarticular injection

ROP/KET/CLON/EPI/SAL

Ketorolac DRUG

ketorolac (30mg/ml)- 1 ml

Also known as: periarticular injection

ROP/KET/CLON/EPI/SAL

Clonidine DRUG

clonidine (0.1mg/ml)- 0.8ml

Also known as: periarticular injection

ROP/KET/CLON/EPI/SAL

Epinephrine DRUG

epinephrine (1mg/ml)-1ml

Also known as: periarticular injection

ROP/KET/CLON/EPI/SAL

0.9% sodium chloride DRUG

Sodium chloride 0.9%- 47.7 ml

Also known as: periarticular injection

Placebo; ROP/KET/CLON/EPI/SAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Written informed consent

You may not qualify if:

• Pregnant women
• Creatinine clearance less than 60 ml/min
• BMI greater than 40
• Currently use greater than 80mg morphine-equivalents daily (pre-operatively)
• Receive a unicondylar knee replacement

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ropivacaine; Ketorolac; Clonidine; Epinephrine; Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Teresa Potter
• Organization: Virginia Commonwealth University

teresa.potter@vcuhealth.org

804-828-6749

Study Officials

• Gregory Golladay, MD

  Virginia Commonwealth University

  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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 7, 2015
• Study Start: October 1, 2015
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: March 4, 2022
• Results First Posted: March 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)