Pre-emptive Local Anaesthesia in Gynecological Laparoscopy
研究概览
详细说明
The study design is prospective, randomized, and double-blinded with parallel assignments. It will compare pre-emptive incisional injection of bupivacaine, 5 mg/ml, with a placebo injection (saline). The clinically relevant comparison should probably be between injection of local anaesthetics and no injection at all. However a study design like that would make blinding impossible and probably not acceptable as a research design for a study which aims to be published.
The aim of the study is to test if pre-emptive injection of long-lasting, local anaesthetics reduces post-operative pain. As local anaesthetics are already implemented in our routine, the hypothesis is that it has a positive effect by reducing postoperative pain. The null hypothesis is that there is no difference between local anaesthetics and placebo.
The recruitment of patients will be from our daily surgery, and consecutive patients who are eligible for day-case, laparoscopic surgery will be asked to participate.
To have a clinically important reduction of post-operative pain a difference of 2 units on a 0-10 numerical rating scale (NRS) is chosen for the sample size calculation. A smaller difference in pain score is not considered clinically relevant in our opinion. With a power of at least 80% this gives 20 patients in total, 10 in each arm. The power calculation was done by statistician S. Johnsen at the University of Surrey. We will include 24 patients altogether to cover for any losses to follow-up. The drop-out rates in clinical trials are usually estimated at 20 %, which would give 25 patients to be included (20/ (1-0.2) = 25). This study has, however, a very short follow-up period, so the drop-out rate is expected to be smaller. Drop-outs will be recorded and accounted for.
24 participants will be randomized in blocks of 6 patients. Block randomization is chosen to avoid pooling by chance.
All procedures will be done by one surgeon. This might be a subject for criticism as one can say that the results in the study are only true for one surgeon in a particular setting. But the need for standardization is very important in studies like this, as pointed out by Wilder-Smith (Wilder-Smith, O. H. 2000).
The time of the randomization is identified as the breakage of the study drug vial. If a potential candidate is found to satisfy any exclusion criteria or withdraws the consent before the vial is opened, the patient is not randomised. The study ID number and the study drug vial will be made available for the next potential candidate.
If a potential candidate is excluded for any reason after the breakage of the vial but before the completion of the injection of the study drug, the study ID number will be coded as Protocol Violation and excluded from the statistical analyses.
The patient, nursing staff and the surgeon will all be blinded to the substance injected.
Infiltration in the primary, umbilical site will be blind, but as close to the fascia as possible. The secondary port infiltrations will be done under visual guidance from the laparoscope, in the fascia and close to the peritoneum. Bupivacaine in a concentration of 5 mg/ml will be used and 5 ml of the solution will be injected at each port site. The patients who get placebo will get 5 ml of physiologic saline injected at each port site.
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours. Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible. Trials measuring both movement evoked pain and pain at rest (PAR) suggests that MEP is much more intense than PAR postoperative (Srikandarajah et al, 2011). Pain will be measured on a 10 cm long Numerical Rating Scale (NRS) where 0 cm is no pain and 10 cm is severe pain. NRS is validated as a good tool for pain measurement at different ages and education levels (Gagliese et al, 2005).
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative, and use of rescue analgesics. Pain at rest must, of course, be recorded before movement evoked pain.
The pain scoring will be done by the patient with help from the nurses at the ward at 2 and 5 hours postoperative, and both will be blinded to which arm the patient is in.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
-
Stavanger、挪威、4068
- Stavanger University Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Women ≥18 years of age
- Planned day-case laparoscopic surgery
- Signed Written Informed Consent
Exclusion Criteria:
- ASA score 3-6
- Chronic pain/ Regular use of analgesics
- Inability to understand Norwegian language
- Drug or alcohol abuse
- Inability to understand or sign the Written Informed Consent form
学习计划
研究是如何设计的?
设计细节
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:bupivacaine
Injection of 5 ml bupivacaine, 5mg/ml in each port site.
|
5 ml in trocar area
其他名称:
|
安慰剂比较:Placebo
Injection of 5 ml saline in each port site.
|
5 ml in trocar area
其他名称:
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Postoperative movement-evoked pain
大体时间:5 hours postoperative
|
The primary outcome of the study will be movement-evoked pain (MEP) 5 hours after surgery, as half-life of bupivacaine is 4-6 hours.
Movement-evoked pain is the most important outcome measure, because the goal is to get the patient back to normal, daily activities as soon as possible.
|
5 hours postoperative
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Pain at rest
大体时间:2 and 5 hours postoperative
|
Secondary outcome measures will be pain at rest at 2 and 5 hours postoperative.
|
2 and 5 hours postoperative
|
Rescue analgetics
大体时间:5 hours postoperative
|
Use of rescue analgesics postoperative.
|
5 hours postoperative
|
合作者和调查者
调查人员
- 首席研究员:Caroline Ravndal, MD、Helse Stavanger HF
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Bupivacaine 5mg/ml的临床试验
-
Jiangsu Kanion Pharmaceutical Co., LtdBeijing Bionovo Medicine Development Co., Ltd.完全的
-
Zurita Laboratorio Farmaceutico Ltda.未知
-
Yuhan Corporation主动,不招人