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

Breast Neoplasm Clinical Trial

Official title:

Pectoral Nerve Block vs. Standard Anesthesia in Patients Undergoing Mastectomy and Immediate Breast Reconstruction: Impact on Post-operative Pain and Nausea/Vomiting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02913573
• Other study ID #: 31801/1
• Status: Recruiting
• Phase: Phase 2
• First received: September 19, 2016
• Last updated: September 22, 2016
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: September 2016
• Source: Huntington Memorial Hospital
• Contact: Jeannie Shen, MD
• Phone: (626) 356-3167
• Email: jeannie[@]jeannieshenmd.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

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

Drug:
• 0.25% bupivacaine
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.

Locations

Country	Name	City	State
United States	Huntington Memorial Hospital	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Huntington Memorial Hospital

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. Review. — View 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 — View Citation

Leiman D, Barlow M, Carpin K, Piña 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 — View 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 aft — View 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 Ma — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-op pain	post-op pain assessed by Visual Analog Scale	within first 48 hours	No
Secondary	Post-op nausea/vomiting	post-op nausea/vomiting score assessed on standard scale	within first 48 hours	No