CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 40 enrolled
Drug / intervention
Solution for Injection in Interscalene Block +5 moredrug
Likely dose
Solution for Injection in Interscalene Block 20mLfrom record
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Search/NCT02741713
NCT02741713Phase 3Completed

Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery

Wake Forest University Health Sciences·interventional·Posted Apr 18, 2016·Updated Aug 27, 2018

In Brief

A Phase 3 clinical trial evaluating PECS "Pectoralis" 1 and 2 Blocks, Interscalene Block, and 4 other interventions for Biceps Tendonitis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 18, 2016
Enrollment StartApr 1, 2016
Primary CompletionJun 29, 2017
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 10.2 years ago

Interventions

PECS "Pectoralis" 1 and 2 Blocksprocedure

An interscalene and a PECS "Pectoralis" 1 and 2 block will be performed on the subjects.

Interscalene Blockprocedure

An interscalene block will be performed on the subjects.

Sham Blockprocedure

Solution for Injection in Interscalene Blockdrug

20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine

Solution for Injection in Sham Blockdrug

Lidocaine 1%

Solution for Injection PECS Blocksdrug

10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2 location