Post Operative Infusion Pump Pain Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bupivacaine 0.5% Injectable Solution, Ropivacaine 0.2% Injectable Solution, 1.3% liposomal bupivacaine (Exparel), ambIT Infusion Pump.
- Who it may be relevant to
- Registry conditions: Post Operative Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
Overview
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
- Drug Bupivacaine 0.5% Injectable Solution
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 - Drug Ropivacaine 0.2% Injectable Solution
Post-operative continuous infusion - Drug 1.3% liposomal bupivacaine (Exparel)
Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel) - Device ambIT Infusion Pump
A pain pump provides intermittent delivery of medication to manage post-surgery pain.
Primary outcome measures
- 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 [Time frame: Postoperative days 0, 1,2,3,4,7,10, 14]
Secondary outcome measures (2)
- Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups [Time frame: Postoperative period through day 14]
- Safety Outcomes [Time frame: Postoperative period through day 14]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University Center for Ambulatory Surgery — Somerset
Identifiers
NCT: NCT07349810 · Pro2022000405