The Effect of Superficial Cervical Plexus Block on Post-Thoracotomy/Scopy Ipsilateral Shoulder Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
研究概览
简要总结
The investigators want to know whether injecting numbing medication on the side of the neck (also called superficial cervical plexus block) can prevent or reduce shoulder pain that patients commonly experience after lung surgery. The investigators will perform the injection at the end of your surgery while the subjects are still under general anesthesia and before they wake up. The investigators will use a local anesthetic (bupivacaine or Marcaine®) that is routinely used for skin infiltration of the surgical wounds.
This study is randomized and single-blind. This means that subjects will be assigned by chance (like flipping a coin) to receive either an injection with active medication (bupivacaine), or no injection at all.
详细描述
Pain management following lung surgery is of outmost importance. Providing adequate pain control facilitates patient recovery and improves lung function, therefore, leading to reduced morbidity and mortality associated with lung surgery. It is now well-established that lung surgery is associated with significant incisional pain, which in some patients may lead to development of chronic post-thoracotomy pain syndrome. In addition, many patients report significant shoulder pain that is often resistant to increasing epidural infusions and intravenous opioid therapy. The incidence of shoulder pain varies from study to study with estimates anywhere between 41% to 97%. Although the cause of the shoulder pain is not well understood, there are only few therapies available for the treatment of shoulder pain including acetaminophen, non-steroidal anti-inflammatory drugs, interscalene brachial plexus and stellate ganglion block. However, all of the currently available therapies have potentially significant side-effects. The investigators are not aware of any studies evaluating the effectiveness of superficial cervical plexus block in reducing or preventing shoulder pain following thoracotomy or thoracoscopic surgery. The superficial cervical plexus block is minimal risk procedure equivalent to an IV start.
The primary aim of this study is to compare the effect of superficial cervical plexus block when added to thoracic epidural analgesia and intravenous patient controlled analgesia (PCA) to standard thoracic epidural analgesia and PCA used at our institution on the incidence of shoulder pain.
Subjects participating in this study will receive standard clinical care in addition to the following research procedures:
- Intra-operative block: an injection of bupivacaine on the side of the neck at the end of the surgery while the subject is still under general anesthesia or no injection at all if in control group. If the subject is assigned to receive an injection, the investigators will be using a small needle similar to the one used to numb the skin for the IV start. There will be a single needle stick on the side of the neck (same side as the lung surgery) and injection of 15 mL of 0.25% bupivacaine under the skin. Regardless of whether the subject gets an injection or not, he/she will receive standard clinical care.
- Post-lung surgery pain assessment: the investigators will ask the subjects to rate their pain at the incision site, chest tube site and shoulder at rest and with movement at 6, 12, 18, 24 and 48 hours after lung surgery. The investigators will also ask the subjects about any side-effects that may be associated with the standard narcotic pain medications.
The investigators will collect the following data from the medical record including:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects who clinically consented to elective thoracotomy or video-assisted thoracoscopic surgery (VATS) under general anesthesia and epidural analgesia
- •ages between 18 and 75 years
排除标准
- •inability to perform thoracic epidural
- •violation of protocol (e.g., administration of medication that does not comply with the study protocol)
- •subject has change of mind
- •surgery has to be repeated
- •Non-inclusion Criteria:
- •subject refusal
- •non-English speaking
- •previous chronic or neuropathic pain
- •previous chronic use of opioids
- •history of psychiatric disorder
- •allergy to local anesthetic
- •previous ipsilateral thoracotomy or VATS
- •prior history of shoulder pain
研究组 & 干预措施
Superficial Cervical Plexus Block
Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
干预措施: Superficial Cervical Plexus Block (Procedure)
Superficial Cervical Plexus Block
Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Incidence of Post-thoracotomy/Scopy Ipsilateral Shoulder Pain
时间窗: 24 hours after lung surgery
次要结局
- Post-operative Opioid Consumption Expressed in Morphine Equivalents(24 hours after the surgery)
- Number of Patients With Post-operative Side Effects Such as Post-operative Nausea and Vomiting (PONV), Pruritus, Sedation, Respiratory Depression and Hypotension(24 and 48 hours after the surgery)
- Numeric Response Scale Pain Scores Around Ipsilateral Shoulder at Rest and During Movement(6, 12, 18, 24 and 48 hours after the surgery)
- Numeric Response Scale Pain Scores at Incision Site at Rest and During Coughing(6, 12, 18, 24 and 48 hours after the surgery)
- Numeric Response Scale Pain Scores Around Chest Tube Insertion Site at Rest and During Coughing(6, 12, 18, 24 and 48 hours after the surgery)
- Number of Participants Requiring Post-operative Ibuprofen as a Rescue Medication(48 hours after the surgery)
研究者
Srdjan Jelacic
Assistant Professor, Anesthesiology & Pain Medicine
University of Washington