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临床试验/NCT02296099
NCT02296099已完成4 期

The Impact of Liposomal Bupivacaine Administered Following Placement of a Retropubic Suburethral Sling for Stress Urinary Incontinence: a Randomized Placebo-controlled Trial

TriHealth Inc.1 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2014年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
114
试验地点
1
主要终点
Pain in the Morning

研究概览

简要总结

The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.

详细描述

The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection. The hypothesis is that administration of liposomal bupivacaine at the completion of retropubic suburethral sling procedure will result in decreased postoperative pain compared to no injection. Although multiple routes for sling placement exist, no difference in pain has been found when comparing obturator verses retropubic suburethral sling. Previous trials have investigated varying formulations of injections along the sling pathway in order to reduce complications such as pain and voiding dysfunction. Local anesthesia along the trocar pathway has shown some improvements in pain. Other techniques, however, have varying results. In 2011, the FDA approved liposomal bupivacaine as a single dose wound infiltration for treatment of postoperative pain following hemorrhoidectomy and bunionectomy. Initial studies demonstrated decreased pain compared to placebo, prolonged release in a bimodal distribution, and greater sensory than motor blockade. Additionally, postoperative benefits such as decreased overall pain, decreased opioid use, and increased time to opioid need were observed. Liposomal bupivacaine may also have the advantage of reducing hospital stays and decreasing overall hospital costs. The side effect profile has similar or improved rates of adverse events compared to traditional bupivacaine, a favorable cardiac profile, and no increased risk of poor wound healing. With such promise, we aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain for the placement of slings to treat stress urinary incontinence. The study will be a blinded randomized controlled trial. Patients randomized to receive liposomal bupivicaine, the standard 20ml vial will be diluted with 1 Oml of saline to a reconstituted volume of 30 ml. Those in the control group will receive 30ml of normal saline injected in the same fashion as the study arm.

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
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Adults greater than 18 years of age
  • Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic suburethral sling under general anesthesia

排除标准

  • Pregnant or nursing
  • Allergy to bupivacaine
  • History of drug/alcohol abuse
  • Severe cardiovascular, hepatic, renal disease, or neurological impairment
  • Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
  • Contraindication to: acetaminophen, oxycodone, and/or non-steroidal anti-inflammatory drugs (NSAID)
  • Administration of an investigational drug within 30 days before study
  • Chronic pain syndromes
  • Daily NSAID/opioid use
  • Patients having concomitant procedures or not undergoing general anesthesia

研究组 & 干预措施

Liposomal Bupivacaine

Experimental

The placement of the retropublic sling will be placed in routine fashion under general anesthesia. If randomized to liposomal bupivacaine, the standard 20 milliliter (ml) vial (266mg dose) will be diluted with 10ml of preservative-free, sterile normal saline (0.9%) for injection to a reconstituted volume of 30ml. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have the 30ml dilutional volume injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed.

干预措施: liposomal bupivacaine (Drug)

Saline Placebo

Placebo Comparator

The placement of the retropublic sling will be placed in routine fashion under general anesthesia. At the completion of the procedure, and at least 20 minutes after the injection of 30ml lidocaine with epinephrine (routine for the surgical procedure), those subjects in the saline placebo arm will receive 30ml normal saline injected. 10ml will be injected into the vaginal epithelium in the mid-urethral area and 10ml will be injected into each of the trocar paths through the suprapubic incisions bilaterally. An aspiration and moving needle technique will be employed.

干预措施: Placebo (Drug)

结局指标

主要结局

Pain in the Morning

时间窗: Day 1

A visual analog scale (VAS) will be used to have the patient rate her pain in the morning of postoperative day one. The VAS scale ranges from 0 to 100 mm. The higher the VAS score the greater the level of pain reported.

次要结局

  • Pain at Four Hours After Discharge Home(1 day, 4 hours after discharge from Same Day Surgery)
  • Total Narcotic Consumption(Day 1 - 3)
  • Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit(1 week)
  • Pain Upon Discharge From Post-anesthesia Care Unit (PACU)(1 day)
  • Pain Upon Discharge From Same Day Surgery(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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