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

• ClinicalTrials.gov Identifier: NCT03119038
• Recruitment Status: Withdrawn
• First Posted: April 18, 2017
• Last Update Posted: December 17, 2020
• Sponsor: Rush University Medical Center
• Information provided by (Responsible Party): Brett Levine, MD, Rush University Medical Center

Study Description

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

Condition or disease	Intervention/treatment	Phase
Osteoarthritis; Degenerative Joint Disease	Drug: Bupivicaine + epinephrine; Drug: Bupivacaine; Drug: Ropivacaine; Drug: Ketorolac; Drug: Clonidine Injection	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
• Estimated Study Start Date: April 30, 2016
• Estimated Primary Completion Date: April 30, 2016
• Estimated Study Completion Date: April 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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
2. 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
3. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

Sponsors and Collaborators

Rush University Medical Center

More Information

• Responsible Party: Brett Levine, MD, Associate Professor, Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT03119038
• Other Study ID Numbers: ORA-15101602
• First Posted: April 18, 2017
• Last Update Posted: December 17, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Brett Levine, MD, Rush University Medical Center:

total hip; degenerative joint disease; osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis; Joint Diseases; Pain, Postoperative; Arthritis; Musculoskeletal Diseases; Rheumatic Diseases; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Ketorolac; Clonidine; Epinephrine; Bupivacaine; Ropivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Anti-Asthmatic Agents