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临床试验/NCT02506660
NCT02506660已完成4 期

Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Nerve Block Duration

研究概览

简要总结

Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.)
  • Age 18-70 years

排除标准

  • Contraindication to interscalene block
  • Known allergy/sensitivity to any study medications
  • Having taken daily steroids for 10 days or longer anytime during the past year
  • Body mass index <18 or >40
  • History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone)
  • Non-English speaking
  • Revision procedures
  • Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.)
  • Planned open procedures
  • History of diabetes
  • Arthroscopic irrigation and debridement secondary to infection
  • Peripheral neuropathies affecting the operative extremity
  • Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain

研究组 & 干预措施

Intravenous dexamethasone

Active Comparator

Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.

干预措施: Bupivacaine (Drug)

Intravenous dexamethasone

Active Comparator

Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.

干预措施: Intravenous dexamethasone (Drug)

Intravenous dexamethasone

Active Comparator

Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.

干预措施: Perineural saline (Drug)

Perineural dexamethasone

Experimental

Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

干预措施: Bupivacaine (Drug)

Perineural dexamethasone

Experimental

Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

干预措施: Perineural dexamethasone (Drug)

Perineural dexamethasone

Experimental

Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

干预措施: Intravenous saline (Drug)

结局指标

主要结局

Nerve Block Duration

时间窗: Postoperative day 2+

Time at which the pain relief from the block has completely worn off

次要结局

  • % of Participants Who Guessed the Correct Group(Postoperative day 7-10)
  • Numerical Rating Scale Pain Scores(Duration of stay in recovery room after surgery (average of 3 hours))
  • Side Effects(Postoperative day 2, postoperative day 3)
  • Block-related Complications(Postoperative day 7-10)
  • Opioid Consumption(Postoperative day 2, postoperative day 3)
  • Block Satisfaction(Postoperative day 2, postoperative day 3)

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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