Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery

• ClinicalTrials.gov Identifier: NCT02741713
• Recruitment Status: Completed
• First Posted: April 18, 2016
• Results First Posted: August 27, 2018
• Last Update Posted: August 27, 2018
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Biceps Tendonitis	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; Drug: Solution for Injection PECS Blocks	Phase 3

Detailed Description:

Subjects that meet the inclusion criteria will be assigned a group by using a random numbers generator. All subjects will receive the standard practice at our institution of an interscalene brachial plexus block along with a general anesthetic. The intervention arm will get an additional local anesthetic block targeting nerves that we presume cover the axillary region (PECS "Pectoralis" 1 & 2). These nerves in the upper chest are the lateral branches of the 2nd to 5th intercostal nerves, which includes the intercostobrachial nerve. The anesthesiologist placing the nerve blocks will be un-blinded to perform the procedures. Both the surgeon and the Acute Pain Service anesthesiologist will be blinded as to whether or not the intervention was provided to any given subject. The Acute Pain Service team will remain blinded and collect the data outcomes.

Initially, pilot data was collected in a total of ten patients with five patients randomized to each arm. Primary endpoint was NRS "Numerical Rating Scale" of 0-10 at 6hrs after block placement. Our pilot data indicate that the mean NRS is about 5 for the control group, with a standard deviation of 1.4. Using a two-sided two-sample t test (an alpha of 0.05 and power of 0.95), we conservatively estimate that 14 subjects per arm will be needed to detect a clinically meaningful difference of 2 in NRS between the arms. We decided to plan enrollment of 20 subjects per arm for potential loss during this randomized, double-blinded, single-center, sham block trial.

• Potential subjects undergoing arthroscopy will have their electronic medical record reviewed by the study team to look for exclusion criteria. If the subject is excluded, then they will be added to the Screening Log with date and reason for their exclusion. If all inclusion criteria are met, then the subject will be approached in the Regional Anesthesia area for their consent. A copy of the consent will be given to the study subject. The other informed consent document will be maintained by the study team in the research files.
• Patients will be asked to provide baseline pain scores both, at rest and with movement, on a scale of 0-10 (0 being no pain and 10 being the worst pain). Preoperative opioid use including drug(s), dosage and frequency will be recorded. Randomization of patients will then occur through the use of sequentially numbered envelopes with only those directly involved in the care of the patient during block placement being aware of which arm of the study the patient has been randomized. Those members of the study team who will be collecting post-operative data will be blinded to the randomization.

Standard American Society of Anesthesiology monitors and oxygen will be applied. Unless there is a contraindication, each patient will receive 650mg "milligrams" of oral acetaminophen. To standardize the effect on postoperative pain, ketamine will not be given as a preoperative sedation medication or intraoperative medication. No long acting opioids will be given in the operating room or post-anesthesia care unit. Intraoperative fentanyl will be limited to 5 micrograms per kg "kilogram". Intraoperative dexamethasone will not be given for post-operative nausea/vomiting prophylaxis.

Subjects will be sedated as per usual practice and will also be blinded to their randomization. All peripheral nerve blocks will be performed by a resident or fellow under supervision by an attending anesthesiologist. The attending anesthesiologist may perform the procedures alone. All volumes and concentrations of nerve block mixtures administered will be identical to assist in the blinding process.

All 40 subjects will receive an ultrasound guided interscalene nerve block using 20mL "milliliters" of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the upper trunk location near the 6th cervical vertebral level, per standard clinical practice. The intervention arm, consisting of 20 patients, will additionally receive the following: 10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine at the PECS2 location as described by Blanco, et al.3,4 All procedures will be performed under a sterile technique including the use of chlorhexidine prep of the skin, sterile gloves, sterile ultrasound probe covers with sterile ultrasound gel, a cap and a mask. For the interscalene block, a 21 gauge 90mm "millimeter" stimulating block needle will be directed, under real-time ultrasound guidance, into the interscalene muscle space at the level of the 5th and 6th cervical nerve roots. Twenty mL of the above local anesthetic mixture will be dosed incrementally, aspirating every 5 mL, to surround the upper trunk of the brachial plexus. For the PECS 1 & 2 block, a 21 gauge 90mm stimulating block needle will be placed under real-time ultrasound guidance at approximately the level of the 4th and 5th ribs near the mid-axillary line. The needle will be advanced into a tissue plane between the serratus anterior muscle and the pectoralis minor muscle. Twenty mL of the same local anesthetic mixture will be dosed incrementally, every 5 mL, to spread within this PEC2 space. The needle will be withdrawn, following the first injection, to a tissue plane between the pectoralis minor and pectoralis major muscles. Ten mL of the same local anesthetic mixture will be dosed incrementally, every 5 mL, to spread within this PEC1 space.

Fifteen and 30 minutes (if no change at 15min) following block placement, success will be assessed by absence/decrease of pin-prick sensation to a 25 gauge Whitacre needle in the following manner:

Cutaneous sensation will be tested over the deltoid region to assess for successful interscalene block.

Cutaneous sensation will be tested over the lateral aspect of the pectoralis muscles at the level of the nipple.

Scoring of sensation will be the following: 0= full sensation, 1= partial sensation, 2= no sensation (complete block) Following block placements, the subjects will be transported to the OR and general anesthesia will be induced. Following intubation, surgical procedure, emergence and extubation, the subject will be transported to the recovery room. In the recovery room or via phone post-discharge, at the 6 hour mark post-block placement, we will ask the subject if they are having any axillary pain. The severity of pain will be determined using the Numerical Rating Scale of 0-10. Zero is no pain and 10 is the most pain possible. Total opiate and benzodiazepine doses will be charted for the preoperative, intraoperative and PACU time frames.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Analgesic Benefit of PECS Blocks for Biceps Tenodesis Shoulder Surgery
• Actual Study Start Date: April 2016
• Actual Primary Completion Date: June 29, 2017
• Actual Study Completion Date: June 29, 2017

Arms and Interventions

Arm	Intervention/treatment
Sham Comparator: Interscalene Block plus Sham Block; 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; 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; Other Names: bupivacaine; epinephrine; clonidine; Drug: Solution for Injection in Sham Block; Lidocaine 1%; Other Name: Lidocaine
Active Comparator: Interscalene plus PECS Blocks; 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; 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.; Drug: Solution for Injection in Interscalene Block; 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine; Other Names: bupivacaine; epinephrine; clonidine; 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; Other Names: bupivacaine; epinephrine; clonidine

Outcome Measures

Primary Outcome Measures :

1. Post-operative Axillary Pain [ Time Frame: 6 hours post-block. ]
   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.

Secondary Outcome Measures :

1. Numerical Rating Scale Pain Scores (0-10) at Rest [ Time Frame: Assessed 24hrs post-block on a scale from 0-10. ]
   Subjects were asked about their overall shoulder pain during the followup phone call at 24hrs post-block. Numerical Rating Scale scores (0-10) will be recorded with 0= no pain, 10=most pain possible. Higher scores denotes worse outcome.
2. Percentage of Participants With Episodes of Nausea or Vomiting [ Time Frame: Assessed 24hrs post-block (yes/no) ]
   Any episodes during the first 24 hours will be recorded as a yes.
3. Total Opioid Usage [ Time Frame: Assessed 24hrs post-block in mg ]
   Recorded in oxycodone equivalents in the first 24 hours post-discharge from the PACU.
4. Time From Block Placement to Onset of Axillary Pain [ Time Frame: Assessed 24hrs post-block in hours ]
   Time self-reported by patients in the Interscalene Plus PECS Blocks group during data collection phone call at 24 hours post-block.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: J.Wells Reynolds, MD; Wake Forest Baptist Health Department of Anesthesiology

  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:

Study Protocol and Statistical Analysis Plan  [PDF] September 29, 2016

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT02741713
• Other Study ID Numbers: IRB00030173
• First Posted: April 18, 2016
• Results First Posted: August 27, 2018
• Last Update Posted: August 27, 2018
• Last Verified: July 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries; Lidocaine; Clonidine; Epinephrine; Racepinephrine; Bupivacaine; Pharmaceutical Solutions; Epinephryl borate; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents