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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03084536
Other study ID # 201703053
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 7, 2017
Est. completion date February 25, 2021

Study information

Verified date March 2022
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date February 25, 2021
Est. primary completion date February 25, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital: - unilateral axillary dissection - unilateral modified radical mastectomy - mastectomy with same day unilateral reconstruction - unilateral sentinel lymph node biopsy (SLNB) - partial mastectomy with unilateral SLNB - simple mastectomy with unilateral SLNB - At least 18 years of age. - Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document. - Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030). Exclusion Criteria: - Planned for bilateral axillary or bilateral reconstruction surgery. - Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy - Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment. - Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels. - Known contraindications to peripheral nerve block placement. - Pregnant or breastfeeding. - History of allergic reactions attributed to compounds of similar chemical or biologic composition - Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)

Study Design


Intervention

Drug:
Bupivacaine
-Given after general anesthesia
Gabapentin
As per routine care Will not be prescribed for any patient with preexisting kidney disease or = 65 years.
Celecoxib
As per routine care Will not be prescribed for any patient with preexisting kidney disease or = 65 years. Naproxen will be substituted for celecoxib in patients with sulfa allergies.
Acetaminophen
-As per routine care
Midazolam
-As per routine care
Fentanyl
-As per routine care

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.
0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
At 1 year
Primary Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year The participant is asked to rate their pain by circling the one number that best describes their pain on the average.
0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain.
At 1 year
Primary Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.
0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain.
The scores for each subsection will be averaged.
At 1 year
Secondary Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
The higher the score the better quality of life.
Scores are standardized to a mean of 50 with a range of -0.809-70.71.
At baseline and 1 year post-surgery
Secondary Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
The higher the score the better quality of life.
Scores are standardized to a mean of 50 with a range of -1.465-77.09.
At baseline and 1 year post-surgery
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