Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Postoperative Day 1 Pain
研究概览
简要总结
Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
详细描述
This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA physical status I-III
- •Age >18 years
- •Not Pregnant
- •Able to give informed consent
- •Electively chose surgical management of SUI with a suburethral sling
排除标准
- •Pregnant or nursing
- •Allergy to amide anesthetics
- •History of drug or 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
- •Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
- •Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
- •Administration of an investigational drug within 30 days before this study
- •Chronic pain syndromes
- •Daily NSAID or opioid use
- •Patients undergoing concomitant procedures
研究组 & 干预措施
Liposomal Bupivacaine
20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
干预措施: Liposomal Bupivacaine (Drug)
Liposomal Bupivacaine
20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
干预措施: Suburethral Sling (Procedure)
Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
干预措施: Bupivacaine Hydrochloride and Lidocaine (Drug)
Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
干预措施: Suburethral Sling (Procedure)
结局指标
主要结局
Postoperative Day 1 Pain
时间窗: Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed.
次要结局
- Second Stage PACU Postoperative Pain(The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.)
- Postoperative Pain Upon Discharge(The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.)
- Postoperative Pain Four Hours After Discharge(Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.)
- Night of Surgery Postoperative Pain(Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.)
- Postoperative Days 2 through 7 Pain(Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.)
- Preoperative Quality of Recovery(The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.)
- Postoperative Days 1, 7 and 14 Quality of Recovery(The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.)
- Postoperative Narcotic Consumption(The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.)
研究者
charbel salamon
Fellowship Director
Atlantic Health System