Effect of Pectoral Nerve Block on Post-op Pain in Patients Undergoing Mastectomy and Immediate Reconstruction
|ClinicalTrials.gov Identifier: NCT02913573|
Recruitment Status : Unknown
Verified September 2016 by Jeannie Shen, Huntington Memorial Hospital.
Recruitment status was: Recruiting
First Posted : September 23, 2016
Last Update Posted : September 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Device: Ultrasound Drug: 0.25% bupivacaine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||March 2019|
Experimental: GA + Pec Block
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.
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.
Other Name: 0.25% Marcaine
No Intervention: GA only
Patients will receive standard general anesthesia.
- Post-op pain [ Time Frame: within first 48 hours ]post-op pain assessed by Visual Analog Scale
- Post-op nausea/vomiting [ Time Frame: within first 48 hours ]post-op nausea/vomiting score assessed on standard scale
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02913573
|Contact: Jeannie Shen, MD||(626) email@example.com|
|Contact: Denise Pitt, JD||(626) firstname.lastname@example.org|
|United States, California|
|Huntington Memorial Hospital||Recruiting|
|Pasadena, California, United States, 91105|
|Contact: Denise Pitt, JD 626-397-3764 email@example.com|
|Principal Investigator:||Jeannie Shen, MD||Huntington Memorial Hospital|