Para-cervical Block Prior to Laparoscopic Hysterectomy as an Adjuvant Treatment to Reduce Postoperative Pain.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative
研究概览
简要总结
This is a prospective randomized controlled trial in which patients that are scheduled to undergo a laparoscopic hysterectomy would be allocated to one of two groups: Paracervical block with local anesthetic (bupivacaine 0.5%), or placebo. This would be achieved using block randomization. The intervention would be performed after the patient is under general anesthesia, prior to starting the surgery. Patients would be consented in the office or preoperative area (before receiving sedatives). As far as the intervention itself, it would consist of injecting 5 mL of 0.5% bupivacaine into the cervical stroma at 3 and 9 o'clock, which is standard technique for para-cervical block. The remainder of the procedure will then continue in a regular fashion. Alternatively, patients in the control group will be injected with 5 mL of normal saline. The surgeon would be blinded as to patient allocation. Research staff will have previously prepared the formulations (saline or bupivacaine) and have sent them to the operating room prior to beginning the procedure depending on assigned group. At the end of the case, pain will be assessed using a visual analogue scale with a range from 0 to 10 by one of the researches who will also be blinded to the group. This will be done at 30 and 60 minutes after surgical stop time. Additional pain control in the postanesthesia care unit (PACU) will be standardized to all patients.
Hypothesis:
Performing a para-cervical block with local anesthetic prior to a laparoscopic hysterectomy significantly reduces pain after the procedure
详细描述
Specific aims:
-Determine if infiltrating the cervical stroma with local anesthetic prior to performing a hysterectomy will reduce postoperative pain scores, and hence increase patient satisfaction.
Secondary aims:
- Determine if there is a difference in baseline pain depending on additional procedures performed, and their response to the paracervical block.
- Determine if there is a difference in response to paracervical block based on history of cesarean deliveries or uterine weight.
Background/Significance:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Undergoing laparoscopic hysterectomy with or without salpingoophorectomy for benign indications
- •Undergoing laparoscopic hysterectomy with robotic assistance with or without salpingoophorectomy for benign indications
- •Between 18 and 60 years of age
排除标准
- •Intraoperative detection of malignancy
- •Undergoing additional procedures at the time of surgery (except prophylactic McCall culdoplasty/uterosacral ligament suspension, excision of endometriosis, appendectomy, cystoscopy)
- •Inability to perform paracervical block due to anatomic abnormalities (absent/flush cervix)
- •Known allergy/sensitivity to bupivacaine
- •Intraoperative bowel injury, bladder injury, ureter injury or major vessel injury that required repair.
研究组 & 干预措施
Control Group
Injection of 10 mL of 0.9% sodium chloride into the cervical stroma divided between 3 and 9 o'clock
干预措施: 0.9% Sodium Chloride (Drug)
Study Group
Injection of 10 mL of 0.5% bupivacaine into the cervical stroma divided between 3 and 9 o'clock.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Pain Reported on the Visual Analogue Scale (VAS) at 30 Minutes Postoperative
时间窗: 30 minutes post-operative stop time
Scale used is the Visual analogue scale for pain. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.
Pain Reported on the Visual Analogue Scale (VAS) at 60 Minutes Postoperative
时间窗: 60 minutes
Postoperative pain score on the Visual analgoue scale at 60 minutes from surgical stop time. Scale ranges from 0 being no pain, to 10 being worse pain ever experienced.
次要结局
未报告次要终点