Skip to main content
OpenTrials
Completed

NCT Number: NCT04019834

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Anesthesia, Local Breast Diseases Breast Neoplasms Mastectomy Narcotic Use Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Alabama at Birmingham Hospitals and Affiliated Clinics

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Bupivicaine

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 .

Other names: Placebo

Primary outcomes

  1. Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

    Time frame: Baseline (day of surgery) to 8 hours

    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.

  2. Postoperative Pain

    Time frame: Baseline (day of surgery) to 16 hours (+/- 4 hours)

    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.

  3. Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

    Time frame: Baseline (day of surgery) to 2 days

    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.

  4. Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

    Time frame: Baseline (day of surgery) to 14 days (+/- 3 days)

    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.

  5. Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

    Time frame: Baseline (day of surgery) to 6 months

    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.

  6. Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF)

    Time frame: Baseline (day of surgery) to 12 months

    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.

Secondary outcomes

  1. Postoperative narcotic consumption

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

    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.

  2. Postoperative nausea

    Time frame: Baseline (day of surgery) to 48 hours after surgery

    Patient self-reported nausea within 48 hours after surgery.

  3. Postoperative length of stay

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

    Total length of patients hospital stay after surgery.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy

Acronym: RELIEF

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 15, 2019
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.