Clinical trial NCT04019834: Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
Official title: Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Mastectomy
Anesthesia, Local
Narcotic Use
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-07-15
Enrollment: 21
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Surgical intervention of breast cancer is vital to breast cancer treatment or prevention and patient outcomes. However, surgical therapy can lead to chronic pain that may affect quality of life for breast cancer survivors including the potential for long-term disability. Chronic pain after breast cancer surgery is common, occurring in about 25-50% of patients. This chronic pain commonly affects women following a mastectomy and is referred to as Post Mastectomy Pain Syndrome (PMPS). Regional anesthesia utilizing single dose nerve blocks is frequently utilized in the preoperative period for many surgical procedures and decreases postoperative pain. Regional anesthesia also frequently results in decreased narcotic use in the post-operative period. The use of regional fascial plane blocks or Pectoralis (PECs) blocks has increased in the setting of mastectomy. The regional block utilizes ultrasound guidance to inject local anesthesia into the fascial planes of muscles thereby infiltrate the surrounding nerves. One example is the pectoral I block which deposits local anesthetic between the pectoralis major and minor muscles and pectoral II above the serratus anterior muscle with an intended blockade for intercostals III, IV, V, VI and long thoracic nerves. These techniques have shown a decrease in postoperative pain and postoperative narcotic consumption. The investigators seek to evaluate if preoperative regional nerve blocks decrease post mastectomy chronic pain, improving the quality of life of breast cancer survivors. Therefore, the aim of this study is to determine whether regional nerve blocks affect chronic post-mastectomy pain and whether the regional block is associated with perioperative pain and postoperative narcotic consumption.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: Baseline (day of surgery) to 8 hours
measure: Postoperative Pain
timeFrame: Baseline (day of surgery) to 16 hours (+/- 4 hours)
measure: Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: Baseline (day of surgery) to 2 days
measure: Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: Baseline (day of surgery) to 14 days (+/- 3 days)
measure: Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: Baseline (day of surgery) to 6 months
measure: Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)
timeFrame: Baseline (day of surgery) to 12 months
Secondary outcomes:
measure: Postoperative narcotic consumption
timeFrame: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
measure: Postoperative nausea
timeFrame: Baseline (day of surgery) to 48 hours after surgery
measure: Postoperative length of stay
timeFrame: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Hospitals and Affiliated Clinics
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Rachael B Lancaster, MD
role: PRINCIPAL_INVESTIGATOR
References: