Speeding Recovery From Pain and Opioid Use



Status:Not yet recruiting
Conditions:Breast Cancer, Cancer, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/17/2018
Start Date:November 2018
End Date:June 2020
Contact:Doug Jaffe, DO
Email:jjaffe@wakehealth.edu
Phone:3367165955

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Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery

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.

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. Surgical treatments can also negatively influence social exposure and alter
self-perception and sexual health. Reconstruction of the breast mound following mastectomy
has several benefits in psychosocial functioning, body image and satisfaction with breast
appearance, and sexual well-being. However, reconstruction at the same time as mastectomy has
been linked to higher postoperative pain. Compared to autologous breast reconstruction,
implant based techniques have been linked to higher requirements of postoperative
nonsteroidal anti-inflammatory drugs, opioids, and benzodiazepines as well as higher pain
scores in the immediate postoperative period and one year after surgery. Recent publications
report that intensity of pain in the operative area prior to surgery, body mass index (BMI),
presence of axillary operation, intensity of acute postoperative pain, and amount of opioid
required to achieve satisfactory analgesia in the acute postoperative period are also risk
factors for persistent pain following breast cancer surgery (PPBCS). Since severity of acute
postoperative pain is consistently observed as a risk factor for persistent pain, there has
been interest in determining whether better acute pain control reduces this risk.
Infiltration of the surgical site with bupivacaine decreases intraoperative and postoperative
narcotic use, and has been associated with decreased pain scores in the immediate
postoperative period. A novel approach to hemithoracic analgesia has been introduced which
proposed less risk of anatomic trespass by doing a local anesthetic injection into the
fascial planes of the chest wall. These procedures have demonstrated improved analgesia for
breast surgeries. Unfortunately, there is a lack of large, multicenter, prospective, and
randomized trials comparing these analgesic modalities and evaluating the response to these
acute postoperative analgesic interventions with regard to PPBCS and other metrics of daily
function, satisfaction with pain control, and self-perception of well-being and predictors of
recovery from the pain state. The goals of this research are to provide short-term surrogate
measures for prevention or treatment trials and to develop methods enabling practitioners to
forecast recovery in real-time and that are translatable to patients in understandable
references regarding risk over time.

Inclusion Criteria:

- Patients scheduled for unilateral mastectomy with immediate issue expander and implant
based reconstruction.

- Age ≥ 18 years

- Ability to understand, read, and write English, and the willingness to sign an
IRB-approved informed consent document.

- Patients who receive a tissue expander placement will be included in the study.

- American Society of Anesthesiologists physical status I-III patients.

Exclusion Criteria:

- Patients who receive an autologous tissue reconstruction.

- Patients who receive a bilateral reconstruction.

- Patients who receive a direct to permanent implant reconstruction

- Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy
(greater than 100 mg equivalents of oral morphine per day)

- Patients who are wards of the state

- Patients who cannot read or speak English

- History of allergic reactions attributed to compounds with known or suspected
cross-sensitivity to bupivacaine.

- Pregnant or breast feeding

- Inability to access to the internet on a daily basis
We found this trial at
1
site
1 Medical Center Boulevard
Winston-Salem, North Carolina 27157
Phone: 336-716-5955
?
mi
from
Winston-Salem, NC
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