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Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Critical to patient recovery, and can contribute to faster patient mobilization, shorter hospital stays and reduced health care costs. The administration of local anesthetics via wound infiltration is standard of care and an effective practice for post surgical pain management, However this method only provides relatively brief analgesia, usually lasting only 12 hours. Other FDA approved delivery systems using an indwelling fusion pump catheter (On-Q pump) are currently being used in our practice and may be used to extend the duration of action of locally administered analgesia by continuously infusing anesthetic into the wound. Alternatively, a depot form of bupivacaine has been FDA approved and currently used to deliver a single dose administered via wound infiltration for prolonged analgesia by allowing for the diffusion of the drug over an extended period of time. Both of these products are used as a standard practice during DIEP free flap reconstructions. However, no studies compare the efficacy of these two methods patients undergong unilateral DIEP flap reconstructions has been done in a prospective, randomized control manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depobupivacaine | Experimental | Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. |
|
| OnQ Pump | Active Comparator | Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. |
|
| bupivacaine | Active Comparator | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depobupivacaine | Drug | surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Narcotic Usage | Post-op pain measured by total post-op Morphine equivalents | total hospital stay, an average of 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risal Djohan, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
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The study was closed at interim analysis due to analyzed findings supporting use of exparel for pain control. We felt it would be unethical to continue to with overwhelming positive results.
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| ID | Title | Description |
|---|---|---|
| FG000 | Depobupivacaine | Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia. |
| FG001 | OnQ Pump | Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure. |
| FG002 | Bupivacaine | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Depobupivacaine | Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Narcotic Usage | Post-op pain measured by total post-op Morphine equivalents | Posted | Mean | Standard Deviation | mg/kg/day morphine | total hospital stay, an average of 3 days |
|
The adverse events are collected while the patients were in the hospital, which was an average of 3 days
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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 | Depobupivacaine | Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml. Depobupivacaine: surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Risal Djohan | Cleveland Clinic | 216 312-6146 | djohanr@ccf.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 | Dec 12, 2015 | Dec 13, 2020 | Prot_SAP_000.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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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| OnQ pump | Drug | group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure. |
|
| 0.25% Bupivacaine | Drug | group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. |
|
|
| OnQ Pump |
Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure. |
| BG002 | Bupivacaine | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Bupivacaine | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | OnQ Pump | Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour. OnQ pump: group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Bupivacaine | Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine. 0.25% Bupivacaine: group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle. | 0 | 8 | 0 | 8 | 0 | 8 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |