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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04019834
Recruitment Status : Not yet recruiting
First Posted : July 15, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Rachael Lancaster, MD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Mastectomy Anesthesia, Local Narcotic Use Drug: regional nerve block with local anesthesia of bupivacaine with steroid Other: Placebo regional nerveblock with normal saline Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Patients and all study and hospital personnel will be blinded to randomization assignments except the regional anesthesia team.
Primary Purpose: Prevention
Official Title: Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
Experimental: regional nerve block with local anesthesia
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 combination of bupivacaine, epinephrine and dexamethasone.
Drug: regional nerve block with local anesthesia of bupivacaine with steroid
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 Name: Bupivicaine

Placebo Comparator: regional nerve block with normal saline
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
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 Name: Placebo




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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.
Accepts Healthy Volunteers:   Yes
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 >40kg/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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04019834


Contacts
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Contact: Amandiy N Liwo, MD, MSPH 205-996-5186 amandiyliwo@uabmc.edu
Contact: Melanie Plourde, BS 205-996-5186 melanieplourde@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Rachael B Lancaster, MD University of Alabama at Birmingham

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Responsible Party: Rachael Lancaster, MD, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04019834    
Other Study ID Numbers: IRB-300003680
First Posted: July 15, 2019    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents