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临床试验/NCT03084588
NCT03084588Unknown4 期

Methadone and Interscalene Block for Shoulder Surgery

NorthShore University HealthSystem1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

研究概览

简要总结

Patients undergoing shoulder surgery may experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Two methods are used to control pain in the early postoperative period. First, an interscalene nerve block (ISB) can be placed prior to surgery to block the pain fibers that supply the shoulder. Although an ISB provides effective analgesia for several hours after surgery, the block is associated with the potential for transient or permanent nerve injury. Furthermore, the ISB can wear off suddenly, resulting in the abrupt onset of severe pain. A second method of pain control involves the use of opioids. Opioids can provide potent pain relief following surgical procedures. However, the agents that are commonly used by anesthesiologists and surgeons only produce pain relief for 2-4 hours, which leads to fluctuations in the levels of pain control. Recent data suggest that the use of a long-acting opioid like methadone in the operating room, which provides analgesia for 24-36 hours, may improve pain control after surgery. The aim of this clinical trial is to compare postoperative pain scores and analgesic requirements in patients randomized to receive either an ISB or methadone at the start of shoulder arthroscopic surgery.

详细描述

Shoulder surgery is one of the most common orthopedic operations, with 1.4 million procedures performed worldwide. Advances in surgical technology now allow the majority of these procedures to be performed arthroscopically. A growing number of shoulder arthroscopic procedures are now conducted on an outpatient basis. Effective pain control is therefore essential if a patient is to be sent home on the same day as the operation. This management strategy presents an important challenge to anesthesiologists, surgeons, and postanesthesia care unit (PACU) nurses. The pain of a shoulder arthroscopic procedure is equivalent to an open procedure during the first 24-48 hours, and up to 30% of patients report pain of a severe intensity on the first postoperative day. Poor pain control after surgery is associated with lower patient satisfaction scores, adverse events, and the development of chronic postsurgical pain. A variety of therapeutic strategies have been developed to more effectively control this early postoperative pain. However, there are a number of important limitations to each of these approaches.

There are three general approaches that anesthesiologists use to provide anesthesia and analgesia for shoulder arthroscopic surgery. Traditionally, shoulder surgery has been performed with a general anesthetic and a breathing tube (oral endotracheal intubation). Although this provides effective analgesia for the duration of the operation, the patient will experience pain once the intraoperative anesthetic has worn off. In this setting, the anesthesia care provider administers an opioid through the intravenous line so that the patient will awaken in less pain. In the PACU, the nursing staff continues to administer an intravenous opioid until pain is effectively controlled. There are important limitations to this anesthetic management strategy. Anesthesia care providers must estimate the amount of opioid to administer intraoperatively. Since the individual responses to opioids may vary widely, it is possible that patients may awaken in pain or may difficult to extubate (remove the breathing tube) due opioid-induced respiratory depression. Once admitted to the PACU, the patients' pain can be effectively controlled by the careful titration of opioids by nursing staff (pain of less than 3 on a scale of 0 to 10). However, the duration of the effectiveness of commonly-used opioids is only 3-4 hours. Therefore, the patient may have little pain at the time of hospital discharge, but may experience severe pain several hours later. Oral analgesic agents are used to control pain in the home setting. The use of oral opioids results in variability in the level of pain that each patient experiences. This variability is related to the slow onset time and short duration of effect of these oral agents (results in "peaks and troughs" of postoperative pain).

A second anesthetic technique involves the use of a general anesthetic with an interscalene nerve block (ISB). Over 40 years ago, Winnie et al. described the use of a single interscalene brachial plexus block to provide analgesia following shoulder surgery. This practice involves the injection of a large volume of local anesthetic agent near the nerves of the brachial plexus. An ISB or brachial plexus block is a regional anesthetic technique that blocks the nerves that supply the shoulder, arm, and forearm. The block is typically administered in the preoperative holding area before a general anesthetic is performed. When the patient awakens from the general anesthetic and arrives in the PACU, the nerve block provides pain relief which persists for several hours. The risk of nausea and vomiting is also reduced with an ISB block. In addition, most studies have demonstrated that patients randomized to receive an ISB have shorter PACU and hospital length of stays. The advantages of the ISB block have prompted many clinicians to introduce this regional anesthesia technique into their clinical practices. Although an ISB is a very effective postoperative pain management technique, there are several important limitations. The block is usually performed before entering the operating room and may delay the start of the case. In addition, the needle placement for the block is in the neck, and improper placement may result in a pneumothorax (lung collapse). Approximately 5% of ISBs fail, even in experienced hands. Block failure necessitates the use of opioids to control pain. Temporary phrenic nerve palsy or diaphragm paralysis is common after the ISB is performed. This results in a significant decrement in pulmonary function in many patients, including those with normal baseline respiratory muscle strength. Most importantly, clinical investigations, cadaveric studies, and retrospective reviews have suggested that the nerve roots of the brachial plexus may be particularly susceptible to nerve injury from the local anesthetic used for the nerve block. Studies have demonstrated that the ISB is associated with a higher risk of transient and long-term neurologic complications when compared to other peripheral nerve blocks. Furthermore, it is now recognized that the ISB may result in delayed onset phrenic nerve damage and permanent unilateral diaphragmatic paralysis. Finally, the analgesic effects of the ISB may resolve abruptly, resulting in the sudden perception of severe pain. In light of these risks, some experts have questioned the routine use of ISBs for shoulder surgery.

The third strategy for anesthetic and postoperative pain management involves the use an ISB not only as a postoperative analgesic but also as a primary anesthetic. With this approach, an ISB is performed in the preoperative holding area. Once clinicians are assured that the block is functioning, the patient is transported to the operating room, sedation is administered, and the shoulder surgery performed with a combination of sedation and the regional block. Advantages of this technique include the avoidance of general anesthesia (and associated complications), and a better maintenance of blood flow to the brain. A disadvantage of the technique is that a profound nerve block must be present in order for the procedure to be completed successfully. Careful patient selection is also essential when performing shoulder surgery in a sedated patient in the sitting position (anesthesiologists do not have easy access to the patients' airway). Finally, the patient is at risk for all of the complications of ISB listed previously.

When deciding on the appropriate anesthetic for the patient undergoing arthroscopic shoulder surgery, clinicians must weigh the risks and benefits of each technique. As noted above, each anesthetic approach has important limitations. At Evanston hospital, approximately 75% of shoulder surgery patients have an ISB for their procedure. There is a higher utilization of this block at Glenbrook Hospital and at the orthopedic surgery center.

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
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients presenting for elective shoulder arthroscopic procedures will be eligible for enrollment.

排除标准

  • Preoperative renal failure requiring dialysis
  • Poorly controlled pulmonary disease (severe asthma or COPD) -Contraindication to regional anesthesia (recent anticoagulant use)
  • Sleep apnea or morbid obesity with possible sleep apnea
  • Allergy to methadone
  • Significant preoperative pain requiring treatment with high doses of opioids (more than 6-8 Norco tablets or equivalence per day) or recent history of opioid abuse

研究组 & 干预措施

Methadone

Active Comparator

Patients in the methadone group will receive a single dose of methadone 0.2 mg/kg at induction of anesthesia

干预措施: methadone (Drug)

Interscalene block

Active Comparator

Patients in the intersclene block group will receive an interscalene block prior to induction of anesthesia

干预措施: Interscalene block (Procedure)

结局指标

主要结局

Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

时间窗: at 24 hours

scale of 0 to 10 (0=no pain, 10= worst pain imaginable)

次要结局

  • Pain score on a scale of 0 to 10 (0=no pain, 10= worst pain imaginable)(at 72 hours)
  • hydromorphone consumption(1 hour after admission)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Glenn Murphy

Director Clinical Research

NorthShore University HealthSystem

研究点 (1)

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