Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement

NCT05283980 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 2021P001063
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab

Conditions

Pain, Postoperative; Pain, Acute; Pain, Chest; Pain; Satisfaction, Patient; Opioid Use, Unspecified; Opioids; Harmful Use

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  peri-operative 24-hour consumption of opioids measured as OMEs (Opioid milliequivalents) in patients undergoing CIED procedures with and without Pecs blocks

  24 hours peri-procedure

Secondary Outcomes (2)

• Pain scores on a scale 1 - 10, 1 being the least pain and 10 being the worst pain

  at 1 hour, 12 hour and 24hours

• Patient satisfaction scores

  at 24 hours post-procedure

Study Arms (2)

Bupivacaine Group

EXPERIMENTAL

Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block

Drug: 0.25% Bupivacaine

Control group

PLACEBO COMPARATOR

Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block

Drug: 0.25% Bupivacaine

Interventions

0.25% Bupivacaine DRUG

The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline

Bupivacaine Group; Control group

Eligibility Criteria

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

You may qualify if:

• Patients 18 years of age or older
• Undergoing CIED placement in electrophysiology lab
• Booked with anesthesia service for the procedure.

You may not qualify if:

• Current participation in another interventional study
• Use of mechanical circulatory support device
• Emergent procedures
• Patients receiving other modalities of regional anesthesia like intrathecal morphine
• Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)
• Current use of SSRI, TCA, anti-epileptics, gabapentin, or pregabalin as part of multimodal pain management
• Hypersensitivity to bupivacaine
• Hemodynamics related: Oxygenation outside of normal limits (defined as PaO2 \< 60mmHg on an FiO2 of 1.0 or SpO2 \< 85% within 30 minutes prior to drug administration), Received an infusion or bolus ≥ 0.05 mcg/kg/min of epinephrine o Received an infusion or bolus ≥ 0.50 mcg/kg/min of milrinone, Received an infusion or bolus ≥ 0.20 mcg/kg/min of norepinephrine o Significant clinician or nursing concern, Hemodynamically unstable (defined as HR \> 120, SBP \< 80, MAP \< 50 within 30 minutes prior to drug administration)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

BIDMC

Boston, Massachusetts, 02130, United States

Location

Related Publications (9)

• Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.

  PMID: 32201270 BACKGROUND

• Fujiwara A, Komasawa N, Minami T. Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation. Springerplus. 2014 Aug 5;3:409. doi: 10.1186/2193-1801-3-409. eCollection 2014.

  PMID: 25120950 BACKGROUND

• Mavarez AC, Ripat CI, Suarez MR. Pectoralis Plane Block for Pacemaker Insertion: A Successful Primary Anesthetic. Front Surg. 2019 Nov 20;6:64. doi: 10.3389/fsurg.2019.00064. eCollection 2019.

  PMID: 31824958 BACKGROUND

• Froyshteter AB, Bhalla T, Tobias JD, Cambier GS, Mckee CT. Pectoralis blocks for insertion of an implantable cardioverter defibrillator in two patients with Duchenne muscular dystrophy. Saudi J Anaesth. 2018 Apr-Jun;12(2):324-327. doi: 10.4103/sja.SJA_624_17.

  PMID: 29628849 BACKGROUND

• Pai B H P, Shariat AN, Bhatt HV. PECS block for an ICD implantation in the super obese patient. J Clin Anesth. 2019 Nov;57:110-111. doi: 10.1016/j.jclinane.2019.04.003. Epub 2019 Apr 6. No abstract available.

  PMID: 30965271 BACKGROUND

• Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.

  PMID: 21831090 BACKGROUND

• Hussain N, Brull R, McCartney CJL, Wong P, Kumar N, Essandoh M, Sawyer T, Sullivan T, Abdallah FW. Pectoralis-II Myofascial Block and Analgesia in Breast Cancer Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2019 Sep;131(3):630-648. doi: 10.1097/ALN.0000000000002822.

  PMID: 31408448 BACKGROUND

• Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163.

  PMID: 25376971 BACKGROUND

• Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.

  PMID: 27543533 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain; Chest Pain; Pain; Patient Satisfaction

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Sankalp Sehgal, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Enrolled subjects will be randomized to one of the two study groups, in a 1:1 randomization ratio. Patients randomized to Group 1, or the bupivacaine group, will receive up to 25cc of 0.25% bupivacaine hydrochloride for the PECs blocks. In Group 2, patients will receive up to 25cc of normal saline. Use of placebo is a standard control procedure in clinical trials and will allow for the assessment of unbiased quantitative data on the efficacy across all treatment groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor, Principal Investigator, Anesthesia Attending

Model Details: This is prospective, randomized, triple-blinded placebo-controlled study. Subjects will be randomize to undergo PECs block in the pre-procdure/ pre-operative area with either ).25% bupivacaine or 0.9% normal saline. They will then undergo the CIED placement in electrophysiology lab as current standard of care.

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: March 17, 2022
• Study Start: November 17, 2022
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

US (1)