The Analgesic Effect of Transversus Abdominis Plane (TAP) Block Versus Wound Infiltration Versus Placebo Following Open Radical Prostatectomy, a Double Blinded, Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.
研究概览
简要总结
This study is conducted to evaluate different analgesic treatments effect following operation where the prostate gland is surgically removed.
The different treatments the investigators wish to investigate is:
- Transversus Abdominis Plane (TAP) block.
The TAP block is a rather new method, where a local anaesthetic is deposited between the two inner abdominal muscles. Between these muscles, the nerves that innervates the anterior part of the abdominal wall is situated. 2. Wound infiltration
In this method you deposit a local anaesthetic in the edges of the wound. 3. Placebo
No active local treatment is given.
All patients who wish to participate will be allocated to one of three different treatment groups.
Group 1:
Will receive TAP block with a local anaesthetic and wound infiltration with saline.
Group 2:
Will receive wound infiltration with a local anaesthetic and TAP block with saline.
Group 3:
Will receive TAP block with saline and wound infiltration with saline.
Beside this local treatment all patients will be given systemic Paracetamol (tablet) and Ibuprofen (tablet).
In addition all patients will be given a pump containing morphine. The pump is connected to a button which the patient can activate when they experience pain. This enables the patient to control how much morphine he needs, following the operation.
The hypothesis is that the TAP block is superior in reducing pain and thereby reducing morphine consumption compared to wound infiltration and placebo.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •BMI > 18 and < 35
- •Patients who have given their informed consent and have fully understood the nature and limitations of the study
- •Patient who is planned for radical prostatectomy
排除标准
- •Not able to cooperate to complete the study
- •Is not able to speak and understand danish
- •Allergy towards the drugs which is used in the study
- •Daily use of strong opioids
- •Infection at the injection area
研究组 & 干预措施
TAP block
TAP block with Ropivacaine
Wound infiltration with Saline
干预措施: Naropine (Drug)
Wound infiltration
TAP block with Saline.
Wound infiltration with Ropivacaine.
干预措施: Naropine (Drug)
Placebo
TAP block with Saline.
Wound infiltration with Saline.
干预措施: Placebo (Other)
结局指标
主要结局
A mean visual analogue scale (VAS) pain score 4 hours after surgery when moving from a supine to sitting position between the group receiving active TAP block and the placebo group.
时间窗: 4 hours postoperative
次要结局
- VAS pain score at rest, recorded as a Area Under Curve (AUC/24h)(Recorded 0-24 hours postoperative)
- VAS pain score when moving from a supine to a sitting position, recorded as a Area under Curve (AUC/24h)(Recorded 0-24 hours postoperative)
- Nausea(Recorded 0-24 hours postoperative)
- Sedation(Recorded at 0-24 hours postoperative)
- Vomiting(Recorded 0-24 hours postoperative)
- On-going morphine consumption(Recorded 0-24 postoperative)
- Cumulated morphine consumption(24 hours postoperative)
研究者
Birgitte Ruhnau
Consultant
Rigshospitalet, Denmark