Post Operative Pain
Conditions
Brief summary
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 2 week time increments across the study recruitment period.. Patients 18 years or older undergoing ACL reconstruction, open shoulder labrum or rotator cuff surgery, arthroscopic rotator cuff repair, proximal or distal patellar realignment surgery, open knee arthrotomy cases (i.e. inside out meniscus repair, osteochondral allograft transplantation (OCA), meniscal allograft transplantation (MAT)) at University Center for Ambulatory Surgery, LLC (UOA) will be reviewed for eligibility. Once identified, potential study subjects will be asked whether they are interested in participating in the project. If the patient agrees, the subject will be given the informed consent to read and sign. Objectives: The primary objective is to compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. The second objective is to evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups. Hypotheses: Use of continuous infusion pain pump or single shot peripheral block will result in similar post-operative pain control after outpatient sports medicine surgical cases.
Interventions
DRUG1.3% liposomal bupivacaine (Exparel)
Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)
Preoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients * A bolus of 20cc will be used for saphenous nerve blocks for knee surgeries * A bolus of 15cc will be used for interscalene nerve blocks for shoulder surgeries
DRUGRopivacaine 0.2% Injectable Solution
Post-operative continuous infusion
DEVICEambIT Infusion Pump
A pain pump provides intermittent delivery of medication to manage post-surgery pain.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study will be a pragmatic, prospective cluster randomized trial, where clusters will formed based on sequential 4 week time increments across the study recruitment period.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * ACL reconstruction * Open shoulder labrum or rotator cuff surgery * Arthroscopic rotator cuff repair * Proximal or distal patellar realignment surgery * Open knee arthrotomy cases - Inside out meniscus repair, OCA, MAT
Exclusion criteria
* Age under 18 years * Body mass index of greater than 40 kg/m2 * American Society of Anesthesiologist class 4 physical status or greater * History of drug or alcohol abuse * Chronic opioid use/pain management doctor * Allergy to bupivacaine, ropivacaine or pharmacologic analogs * Any coagulation disorders * Existing nerve injury * Severe bronchopulmonary disease * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period | Postoperative days 0, 1,2,3,4,7,10, 14 | Compare the effectiveness of postoperative infusion pain pump versus preoperative nerve block in reducing visual analog pain scores/numerical pain rating scale (VAS/NPRS) in the postoperative period. NPRS score difference of approximately 1.5 +/- 1 (approximately 2 points) to detect clinically significant difference in pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups | Postoperative period through day 14 | use of narcotic and other analgesic pain medication throughout the 14 day postoperative period |
| Safety Outcomes | Postoperative period through day 14 | Evaluate the rates of catheter site infection, extravasation, pump malfunction |
Countries
United States
Contacts
CONTACTCharles Gatt, MD
Outcome results
None listed