A Phase 2 interventional study of Ultrasound and 0.25% bupivacaine in Breast Neoplasm, sponsored by Huntington Memorial Hospital. Status unknown at 1 site in United States. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Huntington Memorial Hospital · Phase 2, Interventional, and Treatment
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.
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.
12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Huntington Memorial Hospital is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
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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:
Exclusion Criteria:
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
Patients will receive standard general anesthesia.
Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.
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
Post-op pain
post-op pain assessed by Visual Analog Scale
Time frame: within first 48 hours
Post-op nausea/vomiting
post-op nausea/vomiting score assessed on standard scale
Time frame: within first 48 hours
Plan to share: No
This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Huntington Memorial Hospital