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Early termination due to manufacturer discontinued supplying the product for the study.
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This is a randomized controlled pilot study evaluating length of pain control with either liposomal bupivacaine or with bupivacaine plus decadron after PEC II injection in patients having bilateral mastectomies with immediate reconstruction.
This research hopes to determine the duration of patient-reported analgesia provided by ultrasound guided PEC II field block injections. The design of the study randomly assigns the side of injection of the study drugs into each patient. All patients are having bilateral mastectomy with immediate reconstruction. Visual analog pain scores (VAS) will be recorded serially for both sides of the patient's chest in hopes of determining a difference in duration and efficacy of the two drugs. In addition to VAS scores, a subjective, binary question will be our primary outcome: does one side of your chest have more surgical pain than the other? We hope that his question, despite being entirely subjective, overcomes interpatient variability of numerical pain score reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Left | Active Comparator | Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right |
|
| Liposomal Bupivacaine Right | Active Comparator | Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine right injection | Drug | Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Bilateral Pain Comparison | Subjective, binary question "Does one side of your chest have more surgical pain than the other?" | up to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia | Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale | up to 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Bilateral mastectomy
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| Name | Affiliation | Role |
|---|---|---|
| William Hand, MD | Prisma Health-Upstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Patewood Memorial Hospital | Greenville | South Carolina | 29615 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25376971 | Background | Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. | |
| 28234636 | Background | Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine Left | Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
| FG001 | Liposomal Bupivacaine Right | Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients undergoing bilateral mastectomy with immediate reconstruction at Greenville Memorial Hospital or Patewood Memorial Hospital.
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine Left | Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Bilateral Pain Comparison | Subjective, binary question "Does one side of your chest have more surgical pain than the other?" | Patients undergoing bilateral mastectomy with immediate reconstruction by breast surgeons at Greenville Health System. | Posted | Count of Participants | Participants | up to 48 hours |
|
48 hours
The definition of adverse event and/or serious adverse event, used to collect adverse event information does not differ from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | Liposomal Bupivacaine left injection. Liposomal Bupivacaine is injected on the left, Bupivacaine plus Dexamethasone on the right Liposomal bupivacaine left injection: Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
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Early termination leading to small numbers of subjects analyzed. Manufacturer discontinued supplying product for the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. William R. Hand | Prisma Health | 864.522.3707 | William.Hand@prismahealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 13, 2017 | Sep 26, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2019 | Sep 29, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Only anesthesiologist performing injection will be aware of which side is injected with each drug.
|
| Liposomal bupivacaine left injection | Drug | Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
|
|
| BG001 | Liposomal Bupivacaine Right | Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. |
|
|
| Secondary | Duration of Analgesia | Duration of analgesia perception by patient measured bilaterally using Visual Analog Scale | Patients undergoing bilateral mastectomy with immediate reconstruction by breast surgeons at Greenville Health System. | Posted | Mean | Full Range | hours | up to 48 hours |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Bupivacaine Plus Dexamethasone | Liposomal Bupivacaine right injection. Liposomal Bupivacaine injected on the right, Bupivacaine plus Dexamethasone on the left Liposomal bupivacaine right injection: Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |