A Placebo Controlled, Prospective, Randomized Clinical Investigation of the Efficacy of Continuous Infusion Regional Anesthetic on Postoperative Pain Following Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
This investigation will evaluate the subjective effect on postoperative pain of three catheter placements in the knee:
- intraarticular infusion only,
- patellar tendon harvest site only,
- both intraarticular and patellar tendon harvest site.
详细描述
There will be 96 subjects recruited into this study. Based on power analysis for repeated measures analysis of variance, the sample size required for this investigation is 24 subjects per group based on a 90% confidence interval and alpha of 0.05. There will be 24 subjects in Group 1 (intraarticular bupivicaine infusion only). There will be 24 subjects in Group 2 (patellar tendon harvest site only with bupivicaine). There will be 24 subjects in Group 3 (both intraarticular and patellar tendon harvest site with bupivicaine). There will be 24 subjects in the control, Group 4 (intraarticular infusion physiologic saline only). All patients will be recruited under the discretion of the principal investigator.
The primary outcome measure for this investigation will be the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity level and quality of life. The Postoperative Patient Diary will be administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.
The investigational treatment for this investigation is the use of a Pain Care 3000 continuous infusion regional anesthesia device and accepted pharmacologic modalities for the control of postoperative pain with continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only (Group 1), at the patellar tendon harvest site (Group 2) and combined continuous infusion at the patellar tendon harvest site and intraarticular infusion (Group 3).
Patients randomly assigned to the control group (Group 4) will receive intraarticular infusion physiologic saline only.
The catheter delivers 2 cc of bupivicaine 0.5% per hour total. In patients in Group 3, with 2 catheters (1 in the patellar tendon harvest site and 1 intraarticular infusion), the catheters are connected by a "Y" connector. The dosage of bupivicaine will be split among the two sites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject symptoms
- •Pain restricts work, recreation and/or activities of daily living (ADL)
- •Cognitive function sufficient to understand protocol and to complete subject diary or other analysis tools employed.
- •Must read, write, and understand the English language.
- •American Society of Anesthesiologists (ASA) risk 1 or 2
- •Gender - Both
- •Age 15 - 65 years (parental consent will be obtained on all subjects under age 18).
- •Provided written informed consent
排除标准
- •Neuropathic joint
- •Remote source of ongoing sepsis
- •Severe vascular disease
- •Any medical condition precluding safe anesthesia, surgery, or rehabilitation
- •Comorbid conditions preventing full functional activity or which require continuous use of pain medication.
- •A known history of allergy, sensitivity, or any other form of reaction to local anesthetics of the amide type, acetaminophen, or opioids.
- •Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease, as judged by the investigator.
- •A neurological and/or vascular condition which may affect the outcome of the procedure.
- •Receiving regular treatment with analgesics, sedatives, or any other medication with central nervous system effects.
- •Tendency to bleed
- •Women who are pregnant or are not practicing medically acceptable contraception (a pregnancy test is used pre-operatively as part of standard of care).
- •Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
研究组 & 干预措施
Drug: Bupivicaine 0.5% Intraaticulary Only
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Intraaticular Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
干预措施: Breg Pain Care 3000 Catheter (Device)
Drug: Bupivicaine 0.5% Intraaticulary Only
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Intraaticular Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter
干预措施: Bupivicaine 0.5% (Drug)
Drug: Bupivicaine 0.5% Patellar Tendon Site
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Patellar Tendon Site Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
干预措施: Breg Pain Care 3000 Catheter (Device)
Drug: Bupivicaine 0.5% Patellar Tendon Site
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%;Patellar Tendon Site Only
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter
干预措施: Bupivicaine 0.5% (Drug)
Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%; Intraarticular and Patellar Tendon Sites
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
干预措施: Breg Pain Care 3000 Catheter (Device)
Drug: Bupivicaine 0.5% Intraarticular and Patellar Tendon
Breg Pain Care 3000 Catheter;Bupivicaine 0.5%; Intraarticular and Patellar Tendon Sites
Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter
干预措施: Bupivicaine 0.5% (Drug)
Drug: Placebo
Breg Pain Care 3000 Catheter with Placebo
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
干预措施: Breg Pain Care 3000 Catheter (Device)
Drug: Placebo
Breg Pain Care 3000 Catheter with Placebo
Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter
干预措施: Placebo (Drug)
结局指标
主要结局
Pain
时间窗: 3 day
Pain over the first three days post-operatively. This will be identified by the use of the Postoperative Patient Diary. This document records patient's subjective evaluations of pain, comfort, ability to sleep, activity administered daily on the day of surgery and each morning and each evening before the patient retires for 3 postoperative days. All pain medications taken during the 3 days of the postoperative evaluation will be recorded on the Postoperative Patient Diary.
次要结局
未报告次要终点