Post Operative Infusion Pump Pain Study

Официальное название

Continuous Infusion Pump Versus Single Shot Peripheral Block for Pain Management After Same-day Orthopaedic Surgery

Обзор

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.

Вмешательства

• Препарат 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
• Препарат Ropivacaine 0.2% Injectable Solution
  Post-operative continuous infusion
• Препарат 1.3% liposomal bupivacaine (Exparel)
  Pre-operative infiltrative of 10cc of 1.3% liposomal bupivacaine (Exparel)
• Устройство ambIT Infusion Pump
  A pain pump provides intermittent delivery of medication to manage post-surgery pain.

Первичные конечные точки

• 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 [Срок оценки: Postoperative days 0, 1,2,3,4,7,10, 14]

Вторичные конечные точки (2)

• Evaluate the requirement of narcotic and non-narcotic analgesic medications between the two groups [Срок оценки: Postoperative period through day 14]
• Safety Outcomes [Срок оценки: Postoperative period through day 14]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University Center for Ambulatory Surgery — Somerset

Идентификаторы

NCT: NCT07349810 · Pro2022000405

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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