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

NCT ID: NCT03119038

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-10-25

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

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.

Conditions

Osteoarthritis; Degenerative Joint Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine

Ketorolac

Intervention Type: DRUG

Intraoperative periarticular injection of 30 mg

Clonidine Injection

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Bupivicaine + epinephrine

Intervention Type: DRUG

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

Bupivacaine

Intervention Type: DRUG

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

Interventions

Bupivicaine + epinephrine

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Ropivacaine

Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine

Intervention Type: DRUG

Ketorolac

Intraoperative periarticular injection of 30 mg

Intervention Type: DRUG

Clonidine Injection

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brett Levine, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

ORA-15101602

Identifier Type: -

Identifier Source: org_study_id