University Center for Ambulatory Surgery
Somerset, New Jersey, 08873, United States
Location status: Recruiting
NCT Number: NCT07349810
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Somerset, New Jersey, 08873, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperatively, a nerve block consisting of 0.5% bupivacaine will be given to ALL patients
Post-operative continuous infusion
Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)
A pain pump provides intermittent delivery of medication to manage post-surgery pain.
Time frame: 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.
Time frame: Postoperative period through day 14
use of narcotic and other analgesic pain medication throughout the 14 day postoperative period
Time frame: Postoperative period through day 14
Evaluate the rates of catheter site infection, extravasation, pump malfunction
Contact information is provided by the study sponsor or research team.
Rutgers, The State University of New Jersey
Other
Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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