Pain Management After Total Shoulder Arthroplasty

Stopped early · Phase 4

Conditions studied: Glenohumeral Arthritis, Total Shoulder Arthroplasty

In brief

The purpose of the study is to determine if pain management after total shoulder arthroplasty is more efficacious with ultrasound guided, continuous Interscalene block or with local tissue infiltration with liposomal bupivacaine. Traditionally, general anesthesia followed by narcotics has been the primary management of pain control. However, regional anesthesia in the form of an interscalene block (ISB), a perineural local anesthetic infusion, is commonly used and may more effectively control pain during and after shoulder arthroplasty, with fewer side effects than narcotics. Intraoperative benefits include better control of blood pressure and reduced need for general anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the type of local anesthetic administered, pain relief may persist for 12-96 hours postoperatively. However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may preclude ISB placement. As well, interscalene blocks are not completely benign procedures. Systemic complications include clinically significant intraoperative hypotension, pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death. Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may be devastating. The experience and number of blocks performed by the anesthesiologist in addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the success of the procedure. Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and better early range of motion are other purported benefits. However, premature catheter failure, catheter breakage, infection, over administration of medication and extended diaphragmatic paresis are concerns. In addition, there is a cost associated with these procedures. The anesthesiologist fee, catheter with or without elastomeric pump, local anesthetic, perioperative patient evaluation and treatment of any associated complications all must be considered. . The development of new, long acting local anesthetics, such as liposomal bupivacaine, is potentially important in the management of perioperative pain. Liposomal bupivacaine has been approved by the US Food and Drug Administration for local infiltration for pain relief after bunionectomy and hemorrhoidectomy. This preparation increases the duration of local anesthetic action by slow release from the liposome and delays the peak plasma concentration when compared to plain bupivacaine administration. Studies have shown it to be an effective tool for postoperative pain relief with opioid sparing effects and it has also been found to have an acceptable adverse effect profile.

Key facts

Study ID

NCT03219983

Run by

The Christ Hospital

People needed

22

Starts

2016-11-01

Expected to finish

2017-09-01

Last updated by the study team

2017-11-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be between 18-75 years of age.
• Patients must be candidates for primary total shoulder arthroplasty or reverse total shoulder arthroplasty.
• Patients are determined by the investigator to be suitable candidates.
• Patients must be able to understand and comply with protocol procedures.
• Surgery must be performed at The Christ hospital Joint and Spine Center.
• Patients must have BMI < 40 kg/m2
• Patients must weigh a minimum of 50 kg.
• Patients must have an American Society of Anesthesiologists(ASA) physical status I to III.

You may not qualify if…

• Shoulder arthroplasty performed for an acute proximal humerus fracture.
• Allergy or intolerance to Bupivacaine or ropivacaine.
• Allergy to study medications: midazolam, fentanyl, hydromorphone, or oxycodone.
• History of chronic pain, chronic narcotic use or allergy to narcotics.
• Previous neck surgery or other anatomic abnormalities which would preclude interscalene block.
• Failure of interscalene block placement.
• Patients with end-stage hepatic disease.
• Patients with end-stage renal disease requiring dialysis.
• Patients who are pregnant.

Where it is running

• The Christ Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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