Breast CancerEarly Phase 1RELIEFNCT04019834
Preoperative Regional Nerve Block for Acute and Chronic Post-Operative Pain Following Mastectomy
A Early Phase 1 study testing regional nerve block with local anesthesia of bupivacaine with steroid in people with Breast Cancer and Mastectomy, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mastectomy, Anesthesia, Local
- What is being tested?
- regional nerve block with local anesthesia of bupivacaine with steroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2020to 25 Nov 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham Hospitals and Affiliated Clinics
Birmingham, Alabama, 35233
About this study
Official title: Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use 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.
Read the 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.
- Conditions
- Breast Cancer, Mastectomy, Anesthesia, Local, Narcotic Use
- Being tested
- regional nerve block with local anesthesia of bupivacaine with steroid, Placebo regional nerveblock with normal saline
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional nerve block with local anesthesia of bupivacaine with steroidDrug
Also called Bupivicaine
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.
Placebo regional nerveblock with normal salineOther
Also called Placebo
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo regional nerveblock with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (day of surgery) to 12 months
Secondary outcomes (3)
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.
Measured: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
Postoperative nausea
Patient self-reported nausea within 48 hours after surgery.
Measured: Baseline (day of surgery) to 48 hours after surgery
Postoperative length of stay
Total length of patients hospital stay after surgery.
Measured: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2019
- Study start6 Jul 2020
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachael Lancaster, MD, University of Alabama at Birmingham
- Investigators
- Rachael B Lancaster, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04019834
- Sponsor's protocol ID
- IRB-300003680
- Acronym
- RELIEF
- Status last verified
- Aug 2022
- First submitted
- 3 Apr 2019
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Regional Nerve Block to Decrease Acute and Chronic Post-Operative Pain and Narcotic Use Following Mastectomy
- ClinicalTrials.gov ID
- NCT04019834
- Acronym / sponsor ID
- RELIEF / IRB-300003680
- Conditions
- Breast Cancer, Mastectomy, Anesthesia, Local, Narcotic Use
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 15 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regional nerve block with local anesthesia | Experimental | Drug: regional nerve block with local anesthesia of bupivacaine with steroidTreatment 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. |
| regional nerve block with normal saline | Placebo comparator | Other: Placebo regional nerveblock with normal salinePlacebo Comparator Arm (n=55). Patients will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| regional nerve block with local anesthesia of bupivacaine with steroidAlso: BupivicainePatient 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. | Drug | regional nerve block with local anesthesia |
| Placebo regional nerveblock with normal salineAlso: PlaceboPatients 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 | regional nerve block with normal saline |
Primary outcome
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Postoperative narcotic consumption
Time frame: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
Postoperative nausea
Time frame: Baseline (day of surgery) to 48 hours after surgery
Postoperative length of stay
Time frame: Baseline (day of surgery) to discharge (approximately 2 to 30 days post surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachael B Lancaster, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing regional nerve block with local anesthesia of bupivacaine with steroid in people with Breast Cancer and Mastectomy, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain: Brief Pain Inventory- Short Form (BPI-SF) (time frame: Baseline (day of surgery) to 8 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.