Breast CancerPhase 2NCT03393117
Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Breast Recontruction
A Phase 2 study testing Liposomal Bupivacaine, Bupivacaine and Oral Narcotic in people with Breast Cancer, run by Case Comprehensive Cancer Center.
Trial summary
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Liposomal Bupivacaine, Bupivacaine and Oral Narcotic
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2018to 1 Jul 2020
- Phase
- Phase 2
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to have a unilateral, immediate breast reconstruction
Who cannot join
- Pregnant
- Concurrent or recent medical condition that could interfere with study participation including:
- Hepatitis
- Alcohol/substance abuse
- Uncontrolled psychiatric disorders
- Known allergy
Show all 10Show fewer
- Contraindication to amide-type local anesthetics, opioids, or propofol.
- Body weight of less than 50 kg
- Participated in another study involving an investigational medication within the prior 30 days
- Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
About this study
Official title: Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
The purpose of this study is to determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
Read the detailed description
This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy.
OBJECTIVES
- Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block.
- Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake.
- Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.
- Conditions
- Breast Cancer
- Being tested
- Liposomal Bupivacaine, Bupivacaine, Patient-Controlled Analgesia Pump, Oral Narcotic
- Keywords
- Reconstruction, Bupivacaine, Liposomal Bupivacaine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
Also called Exparel
20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.
BupivacaineDrug
Also called Sensorcaine-Methyl Paraben Free (MPF) Spinal, Sensorcaine-MPF, Sensorcaine, ReadySharp Bupivacaine
20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
Patient-Controlled Analgesia PumpDrug
Also called intravenous narcotic
The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
Oral NarcoticDrug
Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine + Bupivacaine | Experimental | This group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. Receives: Drug: Liposomal Bupivacaine; Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic |
| Bupivacaine | Active comparator | This group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. Receives: Drug: Bupivacaine; Drug: Patient-Controlled Analgesia Pump; Drug: Oral Narcotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
total post-operative narcotic utilization
post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
Measured: Up to 72 hours post-operative
Secondary outcomes (7)
at rest pain score on visual analog scale
0-100 score of self-reported pain
Measured: Up to 72 hours post-operative
coughing pain score on visual analog scale
0-100 score of self-reported pain
Measured: Up to 72 hours post-operative
number of incidents of nausea reported by patient
self-report of nausea
Measured: Up to 72 hours post-operative
number of incidents of vomiting reported by patient
number of times a patient vomits
Measured: Up to 72 hours post-operative
time to first ambulation
Measured: Up to 72 hours post-operative
time to first liquid intake
Measured: Up to 72 hours post-operative
time to first solid intake
Measured: Up to 72 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start30 Mar 2018
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Why it stopped: No accrual
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 Case Comprehensive Cancer CenterThe 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
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Risal Djohan, MD, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393117
- Sponsor's protocol ID
- CASE10117
- Status last verified
- Jul 2020
- First submitted
- 26 Dec 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Blinded Comparison of Bupivacaine Versus Liposomal Bupivacaine For Breast Pain Management After Unilateral, Immediate Breast Reconstruction
- ClinicalTrials.gov ID
- NCT03393117
- Acronym / sponsor ID
- CASE10117
- Conditions
- Breast Cancer
- Keywords
- Reconstruction, Bupivacaine, Liposomal Bupivacaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 8 Jan 2018 (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 determine the most effective way to control post-operative breast pain for patients undergoing a unilateral, immediate breast reconstruction.
Detailed description
This is a randomized controlled study to compare the effectiveness of a breast nerve block performed with bupivacaine as compared to liposomal bupivacaine in providing postsurgical analgesia in patients undergoing unilateral abdominally-based breast reconstruction at time of mastectomy.
OBJECTIVES
- Compare the amount of postoperative narcotic use in patients receiving a bupivacaine or liposomal bupivacaine pectoralis and serratus anterior nerve block. Compare these groups to a retrospective control cohort who received local anesthetic infusion but did not receive any nerve block.
- Examine the incidence of narcotic-related side effects in the experimental groups by documenting incidents of nausea and vomiting, time to first ambulation, liquid and solid oral intake.
- Survey patient satisfaction with pain management using a visual analog scale during their hospital stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine + Bupivacaine | Experimental | Drug: Liposomal Bupivacaine, Drug: Bupivacaine, Drug: Patient-Controlled Analgesia Pump, Drug: Oral NarcoticThis group will receive a long-acting pain medicine, Liposomal Bupivacaine, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. |
| Bupivacaine | Active comparator | Drug: Bupivacaine, Drug: Patient-Controlled Analgesia Pump, Drug: Oral NarcoticThis group will receive the same pain medication, Bupivacaine, but in the standard formulation, injected into the breast muscles during surgery. All patients will receive patient-controlled analgesia pump and oral narcotics as indicated post surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to have a unilateral, immediate breast reconstruction
Key exclusion criteria (10 listed)
- Pregnant
- Concurrent or recent medical condition that could interfere with study participation including:
- Body weight of less than 50 kg
- Participated in another study involving an investigational medication within the prior 30 days
- Taking analgesics (i.e., nonsteroidal anti-inflammatory drugs, acetaminophen, or opioids), antidepressants, or glucocorticoids within the 3 days before surgery.
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 |
|---|---|---|
| Liposomal BupivacaineAlso: Exparel20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks. | Drug | Liposomal Bupivacaine + Bupivacaine |
| BupivacaineAlso: Sensorcaine-Methyl Paraben Free (MPF) Spinal, Sensorcaine-MPF, Sensorcaine, ReadySharp Bupivacaine20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine. | Drug | Bupivacaine, Liposomal Bupivacaine + Bupivacaine |
| Patient-Controlled Analgesia PumpAlso: intravenous narcoticThe patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate. | Drug | Bupivacaine, Liposomal Bupivacaine + Bupivacaine |
| Oral NarcoticOral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1. | Drug | Bupivacaine, Liposomal Bupivacaine + Bupivacaine |
Primary outcome
total post-operative narcotic utilization
Time frame: Up to 72 hours post-operative
post-operative pain as measured by total post-operative narcotic utilization standardized to milligrams of morphine.
7 secondary outcomes
at rest pain score on visual analog scale
Time frame: Up to 72 hours post-operative
coughing pain score on visual analog scale
Time frame: Up to 72 hours post-operative
number of incidents of nausea reported by patient
Time frame: Up to 72 hours post-operative
number of incidents of vomiting reported by patient
Time frame: Up to 72 hours post-operative
time to first ambulation
Time frame: Up to 72 hours post-operative
time to first liquid intake
Time frame: Up to 72 hours post-operative
time to first solid intake
Time frame: Up to 72 hours post-operative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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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.
Risal Djohan, MD principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liposomal Bupivacaine, Bupivacaine and Oral Narcotic in people with Breast Cancer, run by Case Comprehensive Cancer Center.
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 1 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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?
total post-operative narcotic utilization (time frame: Up to 72 hours post-operative). 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 22 Jul 2020.