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NCT03969875 · ClinicalTrials.gov registry record
Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone
A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- 90
- Enrollment target
NCT03969875: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT03969875 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 90 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03969875 has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- 90 participants
- Enrollment target
Study Summary
Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge. With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of "multimodal perineural analgesia (MMPNA)" whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use. Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003. It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thu
Primary Outcome
Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.
Interventions
- DRUG Bupivacaine
- DRUG Dexamethasone
- DRUG Liposomal bupivacaine
- DEVICE Interscalene catheter
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2018-08-18 |
| Est. Completion | 2022-04-05 |
What the finished NCT03969875 record still lists
NCT03969875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target.
The record links to 0 conditions, and to 4 interventions - of which Bupivacaine is the first listed.
NCT03969875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03969875 about?
NCT03969875 is a clinical study titled "Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone". Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene blo...
What is the current status of trial NCT03969875?
This trial is currently completed. The enrollment target is 90 participants. The study started on 2018-08-18. Estimated completion is 2022-04-05.
What interventions are being tested in trial NCT03969875?
The interventions under investigation include: Bupivacaine (DRUG), Dexamethasone (DRUG), Liposomal bupivacaine (DRUG), Interscalene catheter (DEVICE).
Who is sponsoring clinical trial NCT03969875?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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