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NCT02741713 · ClinicalTrials.gov registry record · Phase 3
Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery
A Phase 3 study, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT02741713 is a Phase 3 study that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 40 participants.
The verdict
NCT02741713, a Phase 3 study, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 participants
- Enrollment target
Study Summary
The standard practice for arthroscopic shoulder surgery at our institution is a general anesthetic with a long-acting interscalene block for post-operative pain control, which can reduce the amount of opiates needed after surgery. The interscalene block is effective in providing analgesia to the majority of the shoulder joint and has been shown to reduce post-operative pain scores after arthroscopic shoulder surgeries. However, there is a subset of arthroscopic shoulder surgery patients who have pain in the axilla even in the setting of a functioning interscalene brachial plexus nerve block. One of our surgeons has reported a high incidence of axillary pain in patients who undergo a sub-pectoral biceps tenodesis as part of their arthroscopic procedure. A newly described nerve block approach to the nerves that supply sensation to the axillary region called the PECS "Pectoralis" 1 \& 2 block may provide additional analgesia to these patients. The purpose of this prospective, randomized, observer and patient blinded, single-center, sham block trial is to determine if the addition of PECS blocks to an interscalene block will reduce the severity of axillary pain following arthroscopic shoulder surgery that involves a sub-pectoral biceps tenodesis. Secondarily, the study will assess the duration of PECS 1 \& 2 and whether the block reduces post-operative opioid usage. We hypothesize that the addition of the PECS 1 \& 2 block will reduce the severity of axillary pain at 6hrs and reduce postoperative narcotic usage for the first 24 hours.
Interventions
- PROCEDURE PECS "Pectoralis" 1 and 2 Blocks
- PROCEDURE Interscalene Block
- PROCEDURE Sham Block
- DRUG Solution for Injection in Interscalene Block
- DRUG Solution for Injection in Sham Block
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-04 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02741713
The ClinicalTrials.gov registry entry for NCT02741713 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which PECS "Pectoralis" 1 and 2 Blocks is the first listed.
NCT02741713 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02741713 about?
NCT02741713 is a clinical study titled "Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery". The standard practice for arthroscopic shoulder surgery at our institution is a general anesthetic with a long-acting interscalene block for post-operative pain control, which can reduce the amount of opiates needed after surgery. The interscalene block is effective in providing analgesia to the maj...
What is the current status of trial NCT02741713?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2016-04. Estimated completion is 2017-06-29.
What interventions are being tested in trial NCT02741713?
The interventions under investigation include: PECS "Pectoralis" 1 and 2 Blocks (PROCEDURE), Interscalene Block (PROCEDURE), Sham Block (PROCEDURE), Solution for Injection in Interscalene Block (DRUG), Solution for Injection in Sham Block (DRUG).
Who is sponsoring clinical trial NCT02741713?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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