The Effect of Phrenic Nerve Block on Postoperative Shoulder Pain in Patients for Liver Resection - a Double Blinded Randomised Controlled Trial.
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain measurements on a NRS (Numeric Rating Scale)
研究概览
简要总结
The aim of this study is to explore whether the use of ultrasound guided phrenic nerve block can reduce the postoperative pain in the shoulder after liver resection. The intervention is directed postoperative to the patients experiencing novel right sided shoulder pain.
详细描述
Background:
Patients undergoing both laparoscopic and open hepatic surgery often experience shoulder pain in the postoperative period, mostly on the right side.
The mechanism behind referral of pain from surgical sites to the ipsilateral (same side) shoulder is not fully understood. It has been stated, that the sharing of cervical sensory roots, leads the brain to an interpretation that the pain as originating from the ipsilateral shoulder, when the phrenic nerve is stimulated.
The phrenic nerve provides both sensory and motor nerves to the diaphragm, and sensory fibers to parts of the pleura and peritoneum. Furthermore, one anatomical study indicate, that the phrenic nerve on the right side supply the liver capsule with thin sensory nerves. This could also, in part, explain the shoulder pain after liver surgery.
Studies assessing the effect of phrenic block on shoulder pain by surgically applied intrathoracic block of the phrenic nerve, have found a pain reduction, without significant side effects. There are no available studies on the effect of phrenic nerve block after hepatic surgery. Blocking the nerve intraoperatively, as described in thoracic surgery, is not possible during these operations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above
- •Patients scheduled for liver resection.
- •Ability to give informed consent.
排除标准
- •Participation in another clinical trial, dealing with pain or management of pain, which could affect this trial, evaluated by the investigator.
- •Inability to talk and understand danish
- •Drug or alcohol abuse
- •Pregnancy
- •Congestive heart failure (NYHA class III-IV), or other serious heart disease.
- •Chronic obstructive lung disease, moderate or severe degree, or other significant lung disease
- •Chronic or acute shoulder pain prior to surgery.
- •Body Mass Index above
- •Infection at the site of the injection
- •Allergy to ropivacaine
- •Postoperative:
- •Shoulder pain score < 6 assessed on the numeric rating scale (0-10), 15 minutes after arrival in postanaesthetic care unit (PA CU).
- •Insufficient epidural analgesia, or lack of epidural analgesia.
- •Inability to visualize nervus phrenicus with sonography.
- •Cerebral confusion, postoperative delirium or other medical condition hindering study intervention.
- •Presence of an investigator with intervention competence is not available.
研究组 & 干预措施
Group A
- st intervention: A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml
- nd intervention (approx. 15 minutes after 1st intervention): A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml
干预措施: Ropivacaine (Drug)
Group B
- st Intervention: A single ultrasound guided perineural injection of isotonic saline solution 9 mg/ml, 3 ml
- nd Intervention (approx. 15 minutes after 1st intervention):A single ultrasound guided perineural injection of Ropivacaine 7,5 mg/ml, 3 ml
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Pain measurements on a NRS (Numeric Rating Scale)
时间窗: 1 hour
Patients are asked to rate the intensity of their shoulder pain (if any) according to NRS (Numeric Rating Scale) from 0-10 (0=no pain, 10=the worst pain imaginable). For patients receiving the intervention they are asked to rate the intensity of their pain 15 minutes after the 1st intervention.
次要结局
- Lung function assessed by Spirometry(1 day)
- Lung function assessed by arterial blood gas(1 hour)
- Duration of surgery compared to shoulder pain(1 hour)
- Number of included patients with low pain score (NRS) after interventions.(1 hour and 15 minutes)
- Number of patients with respiratory affection(1 day)
- Number os patients treated with opioid(2 hours)
- Prevalence of respiratory and cardiovascular events amon included and excluded patients.(30 days)
- Pain measurements 24 hours after the 1st intervention.(24 hours)
- Pain measurements on a NRS (Numeric Rating Scale)(2 hours)
研究者
Eske Kvanner Aasvang
MD, PhD
Rigshospitalet, Denmark