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Phase 3 N=40 Randomized Double-blind Treatment

Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery

Biceps Tendonitis

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Post-operative Axillary Pain — 3; 0 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
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); Solution for Injection PECS Blocks (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Jun 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Post-operative Axillary Pain
3; 0
SECONDARY
Numerical Rating Scale Pain Scores (0-10) at Rest
6; 6
SECONDARY
Percentage of Participants With Episodes of Nausea or Vomiting
39; 37
SECONDARY
Total Opioid Usage
31.6; 26.9
SECONDARY
Time From Block Placement to Onset of Axillary Pain
16.7

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.

Eligibility Criteria

Inclusion Criteria

  • Adults, between 18 and 80 years of age
  • Ability to take pills
  • Agreement to a regional with general anesthesia technique

Exclusion Criteria

  • Allergy to amide local anesthetics
  • Presence of a progressive neurological deficit
  • pre-existing coagulopathy
  • Current infection
  • Significant pulmonary disease contraindicating phrenic nerve blockade
  • Chronic use of an opioid analgesic (>3 months of a combined total of more than 40mg oxycodone equivalents a day)
  • Inability to obtain ultrasound images of anatomy due to obesity.
  • Pregnancy
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02741713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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