Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement

NCT03119038 | Withdrawn Phase 4

• 1 other identifier: ORA-15101602
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to clarify the efficacy of a multidrug versus single drug periarticular injection when only standard operative and postoperative pain management protocols used and the control group is exposed to what our investigators believe is the standard of care, single medication periarticular injection

Conditions

Osteoarthritis; Degenerative Joint Disease

Keywords

total hip; degenerative joint disease; osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.

  Narcotic usage

  From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first

Secondary Outcomes (3)

• Record time to achieve physical therapy milestones during inpatient physical therapy

  From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first

• Record VAS values during postoperative period

  From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first

• Length of hospital stay

  From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first

Study Arms (2)

Combination Medication Injection

ACTIVE COMPARATOR

Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine, 30 mg ketorolac, 200 mcg epinephrine, and 100 mcg clonidine in a 100 mL 0.9% saline solution

Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine Injection

Single Medication Injection

ACTIVE COMPARATOR

Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine and 30 mL 0.25% bupivacaine without epinephrine

Drug: Bupivicaine + epinephrine; Drug: Bupivacaine

Interventions

Bupivicaine + epinephrine DRUG

Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine

Single Medication Injection

Bupivacaine DRUG

Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine

Single Medication Injection

Ropivacaine DRUG

Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine

Combination Medication Injection

Ketorolac DRUG

Intraoperative periarticular injection of 30 mg

Combination Medication Injection

Clonidine Injection DRUG

Intraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution

Combination Medication Injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be male or female of any race
• Ages 18-80 years old
• Patients must have a primary hip arthroplasty by principal investigator or co-investigator

You may not qualify if:

• Allergy or intolerance to the study materials
• Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
• History of previous surgeries on the affected joint other ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 than arthroscopy (open surgeries)
• History of or current substance abuse or addiction
• History of or current psychiatric diagnosis
• Failure in collecting a required data point during study

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Joint Diseases

Interventions

Epinephrine; Bupivacaine; Ropivacaine; Ketorolac; Clonidine

Condition Hierarchy (Ancestors)

Arthritis; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 18, 2017
• Study Start: April 30, 2016
• Primary Completion: October 25, 2022
• Study Completion: October 25, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)