Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction

NCT02913573 | Unknown Phase 2 DMC

• 1 other identifier: 31801/1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients undergoing total mastectomy with immediate breast reconstruction with a tissue expander or implant under general anesthesia will be randomly assigned to the addition of a pectoral nerve block or no regional block. Post-operative pain, nausea/vomiting scores will be assessed.

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• Post-op pain

  post-op pain assessed by Visual Analog Scale

  within first 48 hours

Secondary Outcomes (1)

• Post-op nausea/vomiting

  within first 48 hours

Study Arms (2)

GA + Pec Block

EXPERIMENTAL

Following induction of general anesthesia, the patients in the intervention group will undergo an ultrasound-guided pectoral block. With the patient in proper position, the infraclavicular and axillary regions are prepped with chlorhexidine. An US probe is placed below the third of the clavicle over the pectoralis major muscle. After identifying the appropriate anatomical structures, a 21-gauge echogenic needle is advanced under US visualization to the tissue plane between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie and 15 mL of 0.25% bupivacaine will be deposited. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.

Device: Ultrasound; Drug: 0.25% bupivacaine

GA only

NO INTERVENTION

Patients will receive standard general anesthesia.

Interventions

Ultrasound DEVICE

Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.

GA + Pec Block

0.25% bupivacaine DRUG

Pectoral nerve block is a regional block administered under ultrasound guidance where 15 mL of 0.25% bupivacaine is instilled between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.

Also known as: 0.25% Marcaine

GA + Pec Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18-90 years old
• Subjects able to read and understand the informed consent
• American Society of Anesthesiologists (ASA) physical status I and II
• Subjects scheduled to undergo unilateral or bilateral mastectomy with immediate breast reconstruction with submuscular placement of tissue expander or permanent implant under general anesthesia, including:
• subjects diagnosed with breast cancer
• subjects diagnosed with atypia or other high risk proliferative breast disease
• subjects with a family history who are considered at high risk for breast cancer (including those with hereditary or genetic predisposition)

You may not qualify if:

• Subjects unable to read or understand the informed consent
• ASA physical status III or IV
• Subjects with an allergy to local anesthetic
• Subjects with a medical contraindication to regional anesthetic, such as coagulopathy or local infection
• Subjects with a pre-existing submuscular implant
• Subjects scheduled to undergo mastectomy with myocutaneous flap reconstruction
• Subjects scheduled to undergo mastectomy without immediate reconstruction
• Subjects with a history of chronic pain or chronic opioid use

Sponsors & Collaborators

• Huntington Memorial Hospital: lead

Study Sites (1)

Huntington Memorial Hospital

Pasadena, California, 91105, United States

RECRUITING

Related Publications (8)

• 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 RESULT

• Leiman D, Barlow M, Carpin K, Pina EM, Casso D. Medial and lateral pectoral nerve block with liposomal bupivacaine for the management of postsurgical pain after submuscular breast augmentation. Plast Reconstr Surg Glob Open. 2015 Jan 8;2(12):e282. doi: 10.1097/GOX.0000000000000253. eCollection 2014 Dec.

  PMID: 25587516 RESULT

• Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29.

  PMID: 22939099 RESULT

• Wu J, Buggy D, Fleischmann E, Parra-Sanchez I, Treschan T, Kurz A, Mascha EJ, Sessler DI. Thoracic paravertebral regional anesthesia improves analgesia after breast cancer surgery: a randomized controlled multicentre clinical trial. Can J Anaesth. 2015 Mar;62(3):241-51. doi: 10.1007/s12630-014-0285-8. Epub 2014 Dec 6.

  PMID: 25480319 RESULT

• Pei L, Zhou Y, Tan G, Mao F, Yang D, Guan J, Lin Y, Wang X, Zhang Y, Zhang X, Shen S, Xu Z, Sun Q, Huang Y; Outcomes Research Consortium. Ultrasound-Assisted Thoracic Paravertebral Block Reduces Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer Surgery: A Randomized, Controlled, Single-Center Trial. PLoS One. 2015 Nov 20;10(11):e0142249. doi: 10.1371/journal.pone.0142249. eCollection 2015.

  PMID: 26588217 RESULT

• Fahy AS, Jakub JW, Dy BM, Eldin NS, Harmsen S, Sviggum H, Boughey JC. Paravertebral blocks in patients undergoing mastectomy with or without immediate reconstruction provides improved pain control and decreased postoperative nausea and vomiting. Ann Surg Oncol. 2014 Oct;21(10):3284-9. doi: 10.1245/s10434-014-3923-z. Epub 2014 Jul 18.

  PMID: 25034821 RESULT

• Byrne K, Levins KJ, Buggy DJ. Can anesthetic-analgesic technique during primary cancer surgery affect recurrence or metastasis? Can J Anaesth. 2016 Feb;63(2):184-92. doi: 10.1007/s12630-015-0523-8.

  PMID: 26497721 RESULT

• Cassinello F, Prieto I, del Olmo M, Rivas S, Strichartz GR. Cancer surgery: how may anesthesia influence outcome? J Clin Anesth. 2015 May;27(3):262-72. doi: 10.1016/j.jclinane.2015.02.007. Epub 2015 Mar 11.

  PMID: 25769963 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ultrasonography; Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Jeannie Shen, MD

  Huntington Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeannie Shen, MD

CONTACT

(626) 356-3167; jeannie@jeannieshenmd.com

Denise Pitt, JD

CONTACT

(626) 397-3674; denise.pitt@huntingtonhospital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Breast Surgery

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 23, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: March 1, 2019
• Last Updated: September 23, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)