Bupivacaine Hydrochloride in Controlling Pain in Patients with Breast Cancer after Surgery
This randomized phase III trial studies how well bupivacaine hydrochloride works in controlling pain in patients with breast cancer after surgery. Bupivacaine hydrochloride may help relieve moderate or severe pain caused by surgery.
Inclusion Criteria
- Patients >= 18 years of age
- Patients undergoing unilateral mastectomy with or without sentinel lymph node biopsy (SLNB) or axillary dissection
- Patients scheduled for surgery at Josie Robertson Surgery Center (JRSC)
- Previously enrolled patients > 6 months from contralateral mastectomy
Exclusion Criteria
- Patients who are non-English speaking
- Patients having any immediate breast reconstructive procedure
- Patients are having bilateral mastectomy
- Patients who report a baseline pain score > 3, unrelated to a breast procedure
- Patients who take long acting opioid medication use
- Patients will be excluded if they are having their mastectomy performed with tumescence
- Patients weighing < 40 kg, as 20 cc of bupivacaine 0.5% is greater than the maximum allowed dose
- Patients within 6 months of previous enrollment for surgery for contralateral mastectomy
Additional locations may be listed on ClinicalTrials.gov for NCT03351348.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Middletown
Montvale
New York
Commack
New York
Uniondale
West Harrison
PRIMARY OBJECTIVE:
I. To compare rates of moderate to severe pain within the first 6 postoperative hours after arrival at the postanesthesia care unit (PACU) following mastectomy without reconstruction between patients receiving bupivacaine hydrochloride (bupivacaine) and those receiving saline.
SECONDARY OBJECTIVES:
I. To compare the time to first opioid dose in the PACU, total opioid intake in the hospital, and for 7 days after discharge.
II. To compare rates of moderate to severe pain within the first 6 postoperative hours after arrival at the PACU between patients receiving bupivacaine and those receiving saline separately in the subgroups of patients who undergo axillary dissection with their mastectomy and in the subgroup of patients who do not undergo an axillary dissection.
III. To compare rates of moderate to severe pain in postoperative hours 6-12 and 12-24 and for 7 days after discharge, and nausea and vomiting in the PACU, between patients receiving bupivacaine and those receiving saline.
III. To compare scores on the Brief Pain Inventory (Short Form) prior to discharge from the PACU, at the first postoperative visit and at 6 months and 1 year after surgery, between patients receiving bupivacaine and those receiving saline.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: At the completion of surgery, patients receive bupivacaine hydrochloride via a drain tubing into the mastectomy wound cavity over 2 hours.
GROUP II: At the completion of surgery, patients receive placebo via a drain tubing into the mastectomy wound cavity over 2 hours.
After completion of study, patients are followed up at 6 months and 1 year.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorLaurie J. Kirstein
- Primary ID17-576
- Secondary IDsNCI-2017-02250
- ClinicalTrials.gov IDNCT03351348