NCT03388814|WithdrawnEarly Phase 1FDA Drug
Study Stopped
Lack of Funding
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Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 19, 2017
Actual (reported)January 3, 2018
Actual (reported)November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Modeled worst pain intensity using the numeric rating scale (NRS)
NRS pain scores will be obtained daily from time of initiation into the study until 2 months after surgery and the scores following hospital discharge will be modeled for each individual using a growth curve change-point approach. The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
From study start to 2 months after surgery
Area under the curve of the numeric rating scale (NRS)
During the first 48 hours postoperatively
Opioid use
From admission to 2 months after surgery
Those patients randomized to surgeon infiltration will have a skin wheal performed with lidocaine at the site where an actual pectoralis nerve block would be performed as visualized using ultrasound. Surgeons performing infiltration techniques will be blinded to the contents of the injectate and those patients randomized to surgeon infiltration will receive pharmacy study drug labeled bupivacaine injected in the same fashion and volume as the saline group for oncologic and plastic surgery.
Those patients who are randomized to pectoralis nerve block will have randomization immediately preoperatively and will undergo the nerve block procedure using local anesthetic in the standard fashion. Those patients randomized to pectoralis block will have a standard volume of normal saline injected for oncologic and plastic surgery.
Patients assigned to the local infiltration with bupivacaine group will receive 30 ml of 0.25% bupivacaine with 1:200,000 epinephrine. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. The local anesthetic will be injected into the chest wall and skin flaps. Attending physicians and resident physicians will receive prior instruction regarding correct placement of the local anesthetic so that it will be consistently placed in the same locations with similar volume distribution.
Doug Jaffe, DO
Wake Forest University Health Sciences
0 participants (actual enrollment reported by the registry).
First Submitted
December 19, 2017
First Posted
January 3, 2018
Study Start
November 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Integrin α6-targeted SPECT Imaging of Breast Cancer
A Window-of-opportunity Study of Pelareorep in Early Breast Cancer
Length of stay for hospitalization
At Discharge (up to 30 days)
Readmission rates
6 months after mastectomy and breast reconstruction
Patients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane between the serratus anterior and the pectoralis minor muscles at approximately the level of the 4th rib and 10 ml of the same solution in the tissue plane between the two pectoralis muscles at approximately the 3rd rib under ultrasound guidance on the surgical side preoperatively.
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Primary Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2020
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 30, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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