Post Operative Infusion Pump Pain Study

Phase 4RecruitingNCT07349810

Rutgers, The State University of New Jersey80 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Post Operative Pain

Interventions

Bupivacaine 0.5% Injectable SolutionDRUG

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

Ropivacaine 0.2% Injectable SolutionDRUG

Post-operative continuous infusion

1.3% liposomal bupivacaine (Exparel)DRUG

Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)

ambIT Infusion PumpDEVICE

A pain pump provides intermittent delivery of medication to manage post-surgery pain.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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 days 0, 1,2,3,4,7,10, 14

Secondary Outcomes

Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups

use of narcotic and other analgesic pain medication throughout the 14 day postoperative period

Time frame: Postoperative period through day 14

Safety Outcomes

Evaluate the rates of catheter site infection, extravasation, pump malfunction