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

Primary Purpose

Breast Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ultrasound
0.25% bupivacaine
Sponsored by
Huntington Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients age 18-90 years old
  2. Subjects able to read and understand the informed consent
  3. American Society of Anesthesiologists (ASA) physical status I and II

  4. 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)

Exclusion Criteria:

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

Sites / Locations

  • Huntington Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

GA + Pec Block

GA only

Arm Description

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.

Patients will receive standard general anesthesia.

Outcomes

Primary Outcome Measures

Post-op pain
post-op pain assessed by Visual Analog Scale

Secondary Outcome Measures

Post-op nausea/vomiting
post-op nausea/vomiting score assessed on standard scale

Full Information

First Posted
September 19, 2016
Last Updated
September 22, 2016
Sponsor
Huntington Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02913573
Brief Title
Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
Official Title
Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huntington Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 after induction of general anesthesia and prior to the start of surgery. Post-operative pain scores and post-operative pain medication usage will be recorded. Post-operative nausea/vomiting scores and post-op anti-emetic medication usage will be recorded. The clinical impact of pectoral nerve block on this expanding population of patients will be determined.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
GA + Pec Block
Arm Type
Experimental
Arm Description
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.
Arm Title
GA only
Arm Type
No Intervention
Arm Description
Patients will receive standard general anesthesia.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.
Intervention Type
Drug
Intervention Name(s)
0.25% bupivacaine
Other Intervention Name(s)
0.25% Marcaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-op pain
Description
post-op pain assessed by Visual Analog Scale
Time Frame
within first 48 hours
Secondary Outcome Measure Information:
Title
Post-op nausea/vomiting
Description
post-op nausea/vomiting score assessed on standard scale
Time Frame
within first 48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeannie Shen, MD
Phone
(626) 356-3167
Email
jeannie@jeannieshenmd.com
First Name & Middle Initial & Last Name or Official Title & Degree
Denise Pitt, JD
Phone
(626) 397-3674
Email
denise.pitt@huntingtonhospital.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannie Shen, MD
Organizational Affiliation
Huntington Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denise Pitt, JD
Phone
626-397-3764
Email
denise.pitt@huntingtonhospital.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25376971
Citation
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.
Results Reference
result
PubMed Identifier
25587516
Citation
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.
Results Reference
result
PubMed Identifier
22939099
Citation
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.
Results Reference
result
PubMed Identifier
25480319
Citation
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.
Results Reference
result
PubMed Identifier
26588217
Citation
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.
Results Reference
result
PubMed Identifier
25034821
Citation
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.
Results Reference
result
PubMed Identifier
26497721
Citation
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.
Results Reference
result
PubMed Identifier
25769963
Citation
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.
Results Reference
result

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

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