Wound Infiltration With Liposomal Bupivacaine vs. Standard Wound Infiltration With Bupivacaine in Patient's Undergoing Open Gynecologic Surgery on an Enhanced Recovery Pathway: A Single-Blinded, Randomized, Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Participants Opioid-Free After Gynecologic Surgery for 48 Hours
研究概览
简要总结
Bupivacaine is a drug that is traditionally given as an injection to numb surgical sites. Liposomes are molecules that are similar to fats. Sometimes drugs are combined with liposomes to make them able to stay in the body for longer periods of time. This has been done with bupivacaine to create liposomal bupivacaine.
The goal of this clinical research study is to compare the effects of bupivacaine to those of liposomal bupivacaine when given to patients who are having gynecologic surgery. Researchers want to compare how long the drugs work to numb the wound and how long patients take to recover from surgery.
详细描述
Study Arms and Drug Administration:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study arms:
- If you are in Arm 1, you will receive bupivacaine only.
- If you are in Arm 2, you will receive a combination of liposomal bupivacaine and bupivacaine.
You will have an equal (50/50) chance of being assigned to either group. You will not know what you are receiving. However, the study staff will know what you are receiving.
In both cases, the drug(s) will be injected into your skin and tissue at the end of your surgery, right before the wound is closed.
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
- 否
入选标准
- •Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
- •Planned participation in the Gynecologic Enhanced Recovery Pathway
- •Female 18 years of age or older
- •Patient must be able to read and speak English
- •Consents to being part of a randomized, single-blinded study
- •Patient has physical and mental capabilities to take part in study
- •Bilirubin less than or equal to 1.5 x upper limit of the normal range (ULN); Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) </=2.5 x ULN
- •If the patient is of childbearing potential, the patient must have a negative blood or urine pregnancy test within 14 days of surgical treatment on study
排除标准
- •Sensitivity to amide-type local anesthetics
- •Patients on long-acting opioid medications, or scheduled (four or more times a day for seven or more days) short-acting opioid medications within the last 30 days
- •Emergency surgery of any type that does not allow for proper time for protocol review by the patient
- •Surgery that involves known/anticipated resection of anterior abdominal wall with plastic surgery reconstruction
- •Patients undergoing pelvic exenteration
- •Patients undergoing known/anticipated anterior abdominal wall hernia repairs
- •Patients weighing <50 kg
研究组 & 干预措施
Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Bupivacaine (Drug)
Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Oxycodone (Drug)
Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Pill Diary (Behavioral)
Bupivacaine Group
Local wound infiltration with Bupivacaine immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Symptom Questionnaire (Behavioral)
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Bupivacaine (Drug)
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Liposomal Bupivacaine (Drug)
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Oxycodone (Drug)
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Pill Diary (Behavioral)
Liposomal Bupivacaine + Bupivacaine Group
Local wound infiltration with Liposomal Bupivacaine and 0.25% Bupivacaine admixed immediately prior to wound closure during gynecological surgery.
Participants discharged with analgesic opioid regimen of Oxycodone 1-2 tabs (5 mg) by mouth every 4 hours as needed for pain.
Participants complete a pill diary every day for 30 days after hospital discharge.
Participants called or emailed and asked questions about symptoms three (3) and 7 days after hospital discharge, and then 1 time every week after that for a total of 8 weeks.
干预措施: Symptom Questionnaire (Behavioral)
结局指标
主要结局
Participants Opioid-Free After Gynecologic Surgery for 48 Hours
时间窗: 48 hours
Treatment arms compared with respect to the proportion of patients opioid-free at 48 hours using the Cochran-Mantel-Haenszel test stratified by surgeon.
次要结局
- Participants Opioid-Free After Gynecologic Surgery(8 weeks)
- Symptom Scores(Days 0, 2 and 4 postoperatively, up to 8 weeks)