Effect of Local Anesthesia on Postoperative Pain Following Sacrospinous Ligament Fixation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Visual analog pain scale
研究概览
简要总结
During surgery for pelvic organ prolapse, it is common for the surgeon to inject fluid into the vaginal tissues to help with tissue dissection. It is common that anesthetic medication is mixed into this fluid to help with pain control after surgery. Usually the pain medication injected is short-acting. In this study the investigators plan to compare the usual short-acting injected pain medication with a long-acting injected pain medication to evaluate whether this improves pain control after surgery.
One type surgical procedure for prolapse will be evaluated. The procedure is sacrospinous ligament fixation. This is suspension of the vagina to treat pelvic organ prolapse. Study participants will be randomized to one of two study groups:
- Lidocaine group (short-acting medication).
- Liposomal bupivacaine group (long-acting medication)
Information will be collected on study participants, including: demographics, procedure data, and post-operative information. The primary outcome of this study is determine if use of long-acting injected local anesthesia at the time of sacrospinous ligament fixation leads to less post-operative pain compared to short-acting local anesthesia.
Secondary outcomes include:
- post-operative opioid medication use
- return to baseline pain status
- post-operative time to first bowel movement
- post-operative antiemetic use (nausea medication)
- results of voiding trial after surgery
- patient satisfaction with pain control
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female gender
- •Age ≥ 18 years, ≤95 years
- •Planned vaginal sacrospinous ligament fixation with anterior and/or posterior colporrhaphy (SSLF APC) to treat pelvic organ prolapse with or without retropubic mid urethral sling
- •Able to give informed consent to participate
排除标准
- •Age <18 years, > 95 years
- •Unable or unwilling to give informed consent to participate
- •History of chronic pelvic pain, narcotic abuse, or daily narcotic usage in the last six months
- •Known allergy / intolerance to either lidocaine, bupivacaine liposomal, ketorolac, motrin, or acetaminophen
- •Known renal or hepatic insufficiency
- •Planned hysterectomy at the time of prolapse repair
- •Planned transobturator mid urethral sling at the time of prolapse repair
研究组 & 干预措施
Lidocaine group
0.5% lidocaine mixed with 1:200,000 epinephrine 70 milliliters (mL) will be used for local injection at the sacrospinous ligament and for anterior / posterior colporrhaphy
干预措施: Lidocaine (Drug)
Bupivacaine liposomal group
1.3% bupivacaine liposomal (20 mL) injected at the sacrospinous ligament 0.5% lidocaine mixed with 1:200,000 epinephrine 50mL for the anterior / posterior colporrhaphy
干预措施: Bupivacaine liposomal (Drug)
结局指标
主要结局
Visual analog pain scale
时间窗: 1 to 120 hours post-operative
post-operative pain
次要结局
- Equivalents of morphine used for pain control post-operative while hospitalized(1-2 days post-operative)
- Equivalents of morphine used from the time of hospital discharge to post-operative day 7(7 days post-operative)
- Modified surgical pain scale(3, 7, 14, 28 days post-operative)
- Time to first bowel movement(1-28 days post-operative)
- Post-operative antiemetic use, in hospital(1-2 days post-operative)
- Void trial(1-2 days post-operative)
- HCHAPS pain questionnaire(48 hours post-operative)