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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03119038
• Other study ID #: ORA-15101602
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 30, 2016
• Est. completion date: October 25, 2022

Study information

• Verified date: October 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 25, 2022
• Est. primary completion date: October 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Joint Disease
• Joint Diseases
• Osteoarthritis
• Pain, Postoperative

Intervention

Drug:
• Bupivicaine + epinephrine
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine
• Bupivacaine
Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine
• Ropivacaine
Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine
• Ketorolac
Intraoperative periarticular injection of 30 mg
• Clonidine Injection
Intraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Record time to achieve physical therapy milestones during inpatient physical therapy	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
Secondary	Record VAS values during postoperative period	VAS values	From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Secondary	Length of hospital stay	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