Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery

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.

Conditions

• Biceps Tendonitis

Interventions

PROCEDURE

PECS "Pectoralis" 1 and 2 Blocks

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

PROCEDURE

Interscalene Block

An interscalene block will be performed on the subjects.

PROCEDURE

Sham Block

DRUG

Solution for Injection in Interscalene Block

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

DRUG

Solution for Injection in Sham Block

Lidocaine 1%

DRUG

Solution for Injection PECS Blocks

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

Sponsors & Collaborators

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• J.Wells Reynolds, MD · Wake Forest Baptist Health Department of Anesthesiology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2017-06-29

Completion

2017-06-29

FDA Drug

Yes

Countries

• United States

Study Locations