Clinical trial NCT02913573: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Neoplasm
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post-op pain
timeFrame: within first 48 hours
Secondary outcomes:
measure: Post-op nausea/vomiting
timeFrame: within first 48 hours
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
Study officials:
affiliation: Huntington Memorial Hospital
name: Jeannie Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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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.
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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.
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.
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.
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