Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy

NCT04019834 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB-300003680
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Mastectomy; Anesthesia, Local; Narcotic Use

Outcome Measures

Primary Outcomes (6)

• 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

• 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)

• 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

• 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)

• 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

• 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 Outcomes (3)

• Postoperative narcotic consumption

  Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)

• Postoperative nausea

  Baseline (day of surgery) to 48 hours after surgery

• Postoperative length of stay

  Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)

Study Arms (2)

regional nerve block with local anesthesia

EXPERIMENTAL

Treatment Arm (n=55) will receive titrated sedation with a combination of fentanyl and versed prior to the start of the block. An ultrasound will be used to identify the fascial planes and perform regional nerve blocks. A block needle will be passed into the fascial plane an injectate will be deposited . The injectate in the active arm will contain a local anesthestic and dexamethasone.

Drug: regional nerve block with local anesthesia of bupivacaine with steroid

regional nerve block with normal saline

PLACEBO COMPARATOR

Placebo Comparator Arm (n=55). Patients will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue.

Other: Placebo regional nerveblock with normal saline

Interventions

regional nerve block with local anesthesia of bupivacaine with steroid DRUG

Patient will receive titrated sedation with a combination of fentanyl and versed prior to the start of the block. An ultrasound will be used to identify the fascial planes for either pectoral, serratus, or erector spinae nerve blocks. A block needle will be passed into the fascial plane and injectate will be deposited. The injectate in the active arm will contain a combination of bupivacaine, epinephrine and dexamethasone.

Also known as: Bupivicaine

regional nerve block with local anesthesia

Placebo regional nerveblock with normal saline OTHER

Patients who are randomized to placebo will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue .

Also known as: Placebo

regional nerve block with normal saline

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention, at least 19 years old, who are able to provide written and informed consent.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at least 19 years old who are able to provide written and informed consent
• Women undergoing unilateral or bilateral, simple, skin-sparing, or nipple sparing mastectomy for breast cancer (Stage 0-III) or breast cancer prevention
• Patients with ASA class of I-III will be included

You may not qualify if:

• Stage IV breast cancer, morbid obesity with BMI \>45kg/m2
• Renal insufficiency (Creatinine \>1.5 mg/dL)
• Current chronic analgesic use (daily use for \> or equal to 4 weeks)
• History of opioid abuse or dependence
• 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
• Incarceration
• Pregnancy
• Immediate autologous tissue reconstruction.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham Hospitals and Affiliated Clinics

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Steroids; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rachael B Lancaster, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and all study and hospital personnel will be blinded to randomization assignments except the regional anesthesia team.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: July 15, 2019
• Study Start: July 6, 2020
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)