Breast Cancer Clinical Trial
— RELIEFOfficial title:
Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy
Verified date | August 2022 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to see if pre-operative regional nerve blocks compared to a placebo nerve block can decrease chronic post mastectomy pain, immediate postoperative pain and postoperative narcotic consumption.
Status | Completed |
Enrollment | 21 |
Est. completion date | November 25, 2021 |
Est. primary completion date | November 25, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. Women at least 19 years old who are able to provide written and informed consent 2. Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention 3. Patients with ASA class of I-III will be included Exclusion Criteria: 1. Stage IV breast cancer, morbid obesity with BMI >45kg/m2 2. Renal insufficiency (Creatinine >1.5 mg/dL) 3. Current chronic analgesic use (daily use for > or equal to 4 weeks) 4. History of opioid abuse or dependence 5. Presence of chronic pain with a self-reported average pain score of 4 or greater on a pain scale of 0-10 prior to any surgical intervention 6. Incarceration 7. Pregnancy 8. Immediate autologous tissue reconstruction. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham Hospitals and Affiliated Clinics | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) | Severity of postoperative pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 8 hours. This series of questions will be administered in person during the inpatient stay and by telephone or in the clinic setting after discharge. | Baseline (day of surgery) to 8 hours | |
Primary | Postoperative Pain | Severity of postoperative pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 16 hours (+/- 4 hours). This series of questions will be administered in person during the inpatient stay and by telephone or in the clinic setting after discharge. | Baseline (day of surgery) to 16 hours (+/- 4 hours) | |
Primary | Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) | Severity of postoperative pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 2 days. This series of questions will be administered in person during the inpatient stay and by telephone or in the clinic setting after discharge. | Baseline (day of surgery) to 2 days | |
Primary | Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) | Severity of postoperative pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 14 days (+/- 3 days). This series of questions will be administered in person during the inpatient stay and by telephone or in the clinic setting after discharge. | Baseline (day of surgery) to 14 days (+/- 3 days) | |
Primary | Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) | Chronic pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 6 months. This series of questions will be in the clinic setting after discharge. | Baseline (day of surgery) to 6 months | |
Primary | Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) | Chronic pain will be evaluated by the Brief Pain Inventory- Short Form (BPI-SF). This form asks a series of 9 questions with ratings of pain from 0 (no pain) to 10 (pain as severe as you can imagine) and includes questions evaluating general activities of daily living. The study team will evaluate patient reported levels of pain at 12 months. This series of questions will be in the clinic setting after discharge. | Baseline (day of surgery) to 12 months | |
Secondary | Postoperative narcotic consumption | Post-operative narcotic consumption will be measured as the total number of oral morphine-equivalent units administered during hospitalization and subsequent narcotic use will be patient-reported narcotic consumption which will also be converted into oral morphine. | Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery) | |
Secondary | Postoperative nausea | Patient self-reported nausea within 48 hours after surgery. | Baseline (day of surgery) to 48 hours after surgery | |
Secondary | Postoperative length of stay | Total length of patients hospital stay after surgery. | Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery) |
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