Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery

NCT02741713 | Completed Phase 3 Results FDA Drug

• 1 other identifier: IRB00030173
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Post-operative Axillary Pain

  Post-operative ambulatory surgery subjects will be asked 6 hours after block placement about the presence of axillary pain at rest. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.

  6 hours post-block.

Secondary Outcomes (4)

• Numerical Rating Scale Pain Scores (0-10) at Rest

  Assessed 24hrs post-block on a scale from 0-10.

• Percentage of Participants With Episodes of Nausea or Vomiting

  Assessed 24hrs post-block (yes/no)

• Total Opioid Usage

  Assessed 24hrs post-block in mg

• Time From Block Placement to Onset of Axillary Pain

  Assessed 24hrs post-block in hours

Study Arms (2)

Interscalene Block plus Sham Block

SHAM COMPARATOR

Twenty subjects will receive an ultrasound guided interscalene nerve block using the Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. A Sham Block of in area of PECS "Pectoralis" block will be done to allow for assessment of the intervention. Using the Solution for Injection in Sham Block.

Procedure: Interscalene Block; Procedure: Sham Block; Drug: Solution for Injection in Interscalene Block; Drug: Solution for Injection in Sham Block

Interscalene plus PECS Blocks

ACTIVE COMPARATOR

Twenty patients will receive an ultrasound guided interscalene nerve block Solution for Injection in Interscalene Block dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. For the Intervention, these subjects will also a PECS "Pectoralis" 1 and 2 Blocks using the Solution for Injection PECS Blocks, dosed at the PECS1 location and PECS2 location as described by Blanco, et al.

Procedure: PECS "Pectoralis" 1 and 2 Blocks; Procedure: Interscalene Block; Drug: Solution for Injection in Interscalene Block; Drug: Solution for Injection PECS Blocks

Interventions

PECS "Pectoralis" 1 and 2 Blocks PROCEDURE

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

Interscalene plus PECS Blocks

Interscalene Block PROCEDURE

An interscalene block will be performed on the subjects.

Interscalene Block plus Sham Block; Interscalene plus PECS Blocks

Sham Block PROCEDURE

Interscalene Block plus Sham Block

Solution for Injection in Interscalene Block DRUG

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

Also known as: bupivacaine, epinephrine, clonidine

Interscalene Block plus Sham Block; Interscalene plus PECS Blocks

Solution for Injection in Sham Block DRUG

Lidocaine 1%

Also known as: Lidocaine

Interscalene Block plus Sham Block

Solution for Injection PECS Blocks DRUG

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

Also known as: bupivacaine, epinephrine, clonidine

Interscalene plus PECS Blocks

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

• Reynolds JW, Henshaw DS, Jaffe JD, Dobson SW, Edwards CJ, Turner JD, Weller RS, Graves BR, Freehill MT. Analgesic Benefit of Pectoral Nerve Block II Blockade for Open Subpectoral Biceps Tenodesis: A Randomized, Prospective, Double-Blinded, Controlled Trial. Anesth Analg. 2019 Aug;129(2):536-542. doi: 10.1213/ANE.0000000000004233.

  PMID: 31136331 DERIVED

MeSH Terms

Interventions

Solutions; Injections; Bupivacaine; Epinephrine; Clonidine; Lidocaine

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides

Limitations and Caveats

Only 8 patients in the PECS group reported the onset of axillary pain at home, so that data set is very limited.

Results Point of Contact

• Title: Dr.Jon Wells Reynolds
• Organization: Wake Forest Baptist Health

jreynold@wakehealth.edu

336-715-9695

Study Officials

• J.Wells Reynolds, MD

  Wake Forest Baptist Health Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 18, 2016
• Study Start: April 1, 2016
• Primary Completion: June 29, 2017
• Study Completion: June 29, 2017
• Last Updated: August 27, 2018
• Results First Posted: August 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)