Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Total Post-surgical Opioid Medication Use
研究概览
简要总结
The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control.
详细描述
Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia.
After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use.
Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
This will be a blinded study where investigators, patients, and care providers will be blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard Bupivacaine
Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
干预措施: Bupivacaine Hydrochloride (Drug)
Liposomal Bupivacaine
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
干预措施: Liposomal bupivacaine (Drug)
Liposomal Bupivacaine
Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Total Post-surgical Opioid Medication Use
时间窗: First 72 hours following surgery completion
Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Total Post-surgical Analgesic Medication Use
时间窗: First 72 hours following surgery completion
Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)
次要结局
- Emesis at 24, 48, and 72 Hours Post-surgery Completion(24, 48, and 72 hours post-surgery)
- Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score(Assessed while patient in PACU for recovery post-surgery per standard procedure)
- Nausea at 24, 48, and 72 Hours Post-surgery Completion(24, 48, and 72 hours post-surgery)
- VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion(24, 48, and 72 hours post-surgery completion)
- Urinary Retention(At voiding trial prior to discharge from hospital, approximately 72 hours)
- Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery(72 hours and 7-10 days post surgery)