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

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.

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