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

October 25, 2022 updated by: Brett Levine, MD, Rush University Medical Center

Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Study Objectives The 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 will be compared to an injection of 30 mL of a 0.25% solution bupivacaine with ORA: 15101602-IRB01 Date IRB Approved: 3/16/2016 epinephrine and 30 mL 0.25% bupivacaine without epinephrine as an intraoperative periarticular joint injection protocol. The study's data collection timeline begins at the pre-operative clinic visit. Data collection continues through the patient's discharge after the surgical procedure and until the first year postoperative visit examination of joint range of motion and patient satisfaction questionnaires.

Primary Objectives:

The primary objective is to evaluate the efficacy of a multidrug versus bupivacaine intraoperative injection in decreasing total hip arthroplasty postoperative pain. To determine this, postoperative analgesic consumption will be collected for each patient and the value when converted to morphine equivalents will be compared between cohorts.

Analysis of morphine equivalent values at various postoperative time intervals (0-6 hours, 6-12 hours, 12-18, 18-24, then each postoperative day) and total morphine equivalent consumption for the entire length of stay will be performed between treatment cohorts.

Secondary Objectives:

To establish the improvement in postoperative pain relief provided by intraoperative periarticular injection of our multidrug protocol versus bupivacaine, other data points will be collected. The physical therapy milestones including time to first get out of bed, time to ambulation with or without assistance, time to climb stairs, and time to active straight leg raise will all be collected. The zero time point will be the end of the operation. Pain scale scores during physical therapy sessions with physiotherapists will also be recorded.

Resting visual analog scores for pain assessment will be collected as the patient representing their pain on a scale from 0 to 100 mm. The VAS values will be collected at various postoperative time values until discharge. The length of hospital stay will be collected as well. Opioid side effects will also be collected including over sedation, respiratory depression, urinary retention, and constipation. Other data collected will include operation time, wound complications, intraoperative blood loss, and postoperative drain output. At the 6 weeks postoperative visit, patient satisfaction questionnaires will be collected compared to preoperative visit values.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combination Medication Injection
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
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine
Drug: Ketorolac
Intraoperative periarticular injection of 30 mg
Drug: Clonidine Injection
Intraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution
Active Comparator: Single Medication Injection
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
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine
Drug: Bupivacaine
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
Time Frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record time to achieve physical therapy milestones during inpatient physical therapy
Time Frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Time to achieve physical therapy milestones
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
Time Frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
VAS values
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
Time Frame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Length of stay
From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rush University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 30, 2016

Primary Completion (Actual)

October 25, 2022

Study Completion (Actual)

October 25, 2022

Study Registration Dates

First Submitted

April 10, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORA-15101602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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