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Postoperative Pain Control After Periarticular Injection During Total Knee Arthroplasty

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Age 18 or older.
  • - Written informed consent.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02570503
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Virginia Commonwealth University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Gregory Golladay, MD
Principal Investigator Affiliation Virginia Commonwealth University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Osteoarthritis, Knee
Additional Details

Data Collection: Data will be collected from the patient's medical record after discharge. Variables include:

  • - Age.
  • - Sex.
  • - BMI.
  • - UPAT score (Universal Pain Assessment Tool)- this is assessed hourly postoperatively by nursing staff on Orthopedics Unit.
  • - Patient's assessment of acceptability of pain.
  • - UPAT score as assessed by physical therapy pre and post therapy sessions.
  • - Duramorph dose.
  • - Time patient arrived on the Orthopedic Unit.
  • - Length of ambulation during physical therapy sessions.
  • - Amount of supplementary opioids (measured in morphine equivalents) - Use of anti-emetics.
  • - Any complications of surgery including venous thromboembolic event, cardiac event, bleeding event.
  • - Length of hospital stay.
The pharmacist will randomize patients to either study arm, prepare the injection and maintain dispensing records.

Arms & Interventions

Arms

Experimental: ROP/KET/CLON/EPI/SAL

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

Placebo Comparator: Placebo

0.9% Sodium Chloride- 100ml

Interventions

Drug: - Ropivacaine

Ropivacaine (5mg/ml)-50ml

Drug: - Ketorolac

ketorolac (30mg/ml)- 1 ml

Drug: - Clonidine

clonidine (0.1mg/ml)- 0.8ml

Drug: - Epinephrine

epinephrine (1mg/ml)-1ml

Drug: - 0.9% sodium chloride

Sodium chloride 0.9%- 47.7 ml

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virginia Commonwealth University, Richmond, Virginia

Status

Address

Virginia Commonwealth University

Richmond, Virginia, 23298

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