Clinical trial NCT03119038: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Replacement
Official title: Efficacy of Intraoperative Injections on Postoperative Pain Control During Total Hip Arthroplasty: A Prospective, Blinded, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Osteoarthritis
Degenerative Joint Disease
Keywords: total hip
degenerative joint disease
osteoarthritis
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Record narcotic usage, in morphine equivalents, during postoperative inpatient hospital stay.
timeFrame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Secondary outcomes:
measure: Record time to achieve physical therapy milestones during inpatient physical therapy
timeFrame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
measure: Record VAS values during postoperative period
timeFrame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
measure: Length of hospital stay
timeFrame: From date of randomization until the date of hospital discharge or the date of 10 days after surgery, whichever date comes first
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: