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临床试验/NCT03739021
NCT03739021尚未招募2 期

Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)

University of South Florida0 个研究点目标入组 60 人开始时间: 2019年11月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
60
主要终点
Duration of Surgery (in minutes)

研究概览

简要总结

Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Pain is a common side effect that many patients undergo while in the clinical setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as well as overall patient satisfaction. Post-operative pain management typically involves elevated usage of narcotics, which is a concern among clinicians and researchers alike. To combat this issue, research is examining intraoperative procedures as a means of reducing post-operative pain scores.

Research has discovered the advantages of utilizing local anesthetic techniques as opposed to just general anesthesia. Local anesthetic blocks function by preventing the generation of nerve impulses by increasing the action-potential threshold, thereby inhibiting movement. Previous studies have demonstrated the success of local anesthetic interscalene blocks across several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical paravertebral catheter among thoracic procedures.

Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion for post-operative pain scores in total shoulder surgery patients. Additionally, we will collect data on complications, length of stay, and other variables.

详细描述

Procedure Description:

The investigators commonly use these blocks for patients requiring total shoulder replacement: the patient is usually sedated with propofol. The patient is positioned in the lateral decubitus, or sitting position for this block. After the skin preparation and draping, the fingers of the non-operative hand separate the trapezius and levator scapulae muscle and a 25 gauge needle is used to anesthetize the skin and subcutaneous tissue.

The Trapezius and Levator Scapulae muscles are again separated with the non-operative hand and a 17 or 18 gauge insulated tuohy needle is inserted, which is attached to a nerve stimulator set at a current output of one to three milliamps, a frequency of two Hertz, and a pulse width of 200 to 300 microseconds. The needle is advanced towards the suprasternal notch until contact with the bony structures is made.

After contact with the bone the stylet of the needle is removed, the needle tip is walked off the bony structures in a lateral and slightly superior direction remaining on the plane of the line drawn from the dorsal spine of C6 to the suprasternal notch. After walking off of these bones structures the needle is advanced carefully in an anterior direction. As the needle is advanced there will be a motor response from the stimulator current. The muscles involved are usually the triceps, biceps, deltoids or major pectoral muscle but any muscle group of the upper limb would be acceptable for this block since the needle is now in contact with the posterior aspects of the roots of the brachial plexus. The tip of the needle at this point is situated between the anterior and middle scalene muscles and is in contact with the C6 root of the brachial plexus. At this point either a single-shot injection of Exparel will be performed, or a catheter for Ropivacaine will be inserted, as described below.

For catheter insertion: the nerve stimulator is removed from the needle and attached to the proximal end of the stimulating catheter and the tip of the catheter is inserted into the needle shaft. The nerve stimulator is usually set at a current output of one milliamp. The motor response should be unchanged. The catheter is advanced beyond the needle tip, if the motor response disappears, the catheter is careful drawn into the needle shaft and small adjustment to the needle, advancing slightly or withdrawing it slightly is done. This maneuver is repeated until the muscle twitch is unchanged during catheter advance. This indicates the catheter tip is now situated on the nerve root; the catheter is advanced 3 to 5 centimeter beyond the needle tip but not further than 5 centimeters. The needle is then removed without disturbing the catheter and the inner stylet of the catheter is also removed. The catheter position can be confirmed by attaching the nerve stimulator to the catheter, the motor response should be unchanged. The catheter is then subcutaneously tunneled and continuous infusion of Ropivacaine is inserted.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years or older
  • Patients admitted to TGH for total shoulder replacement surgery
  • Subjects who have given written informed consent

排除标准

  • Patients with allergic reactions to Exparel or Ropivacaine
  • Female patients who are pregnant
  • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)

研究组 & 干预措施

Group 1 (30 participants)

Experimental

干预措施: Exparel (Drug)

Group 2 (30 participants)

Experimental

干预措施: Ropivacaine (Drug)

结局指标

主要结局

Duration of Surgery (in minutes)

时间窗: Intraoperative

Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)

时间窗: Intraoperative

Post-Operative VAS Scores (10 cm scale)

时间窗: 1 hour after surgery

Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)

时间窗: through study completion, 8 months-1 year (on average)

Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)

时间窗: through study completion, 8 months-1 year (on average)

Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents

时间窗: First 72 hours after PACU discharge

Length of Hospital Stay (in hours)

时间窗: through study completion, 8 months-1 year (on average)

次要结局

  • Cost of Adjuvant Therapy (in United States Dollar)(through study completion, 8 months-1 year (on average))
  • Time spent Nerve Block Procedure (in minutes)(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

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