Pain Management After Total Shoulder Arthroplasty
Public ClinicalTrials.gov record NCT03219983. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pain Management After Total Shoulder Arthroplasty: Continuous Interscalene Block Versus Local Tissue Infiltration With Liposomal Bupivacaine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03219983
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 22 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- May 31, 2017
- Completion
- Aug 31, 2017
- Last update posted
- Nov 5, 2017
2016 – 2017
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Christ Hospital | Cincinnati | Ohio | 45219 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03219983, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 5, 2017 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03219983 live on ClinicalTrials.gov.