A Phase 4 interventional study of Depobupivacaine and OnQ pump in Pain, Postoperative, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by The Cleveland Clinic · Phase 4, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 21 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →The Cleveland Clinic is the lead sponsor of 818 studies on the registry; 118 are open to participants now.
Of its 89 completed or terminated interventional studies of FDA-regulated products, 72 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Group 1 will receive an injection of 166mg of Depobupivacaine diluted in 60 ml.
Drug: Depobupivacaine
Group 2 : The OnQ group will receive an infiltration via an OnQ soaker catheter of 0.25% bupivacaine at 4 ml/hour.
Drug: OnQ pump
Group 3: The 0.25% bupivacaine patients will receive 2mg/kg of 0.25% bupivacaine.
Drug: 0.25% Bupivacaine
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.
Also known as: Exparel
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.
group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Also known as: Marcaine
Total Narcotic Usage
Post-op pain measured by total post-op Morphine equivalents
Time frame: total hospital stay, an average of 3 days
| Milestone | Depobupivacaine | OnQ Pump | Bupivacaine |
|---|---|---|---|
| Started | 8 | 5 | 8 |
| Completed | 8 | 5 | 8 |
| Not completed | 0 | 0 | 0 |
Post-op pain measured by total post-op Morphine equivalents
| mg/kg/day morphine | Depobupivacaine | OnQ Pump | Bupivacaine |
|---|---|---|---|
| Total Narcotic Usage | 0.8 ± 0.5 | .13 ± .1 | 0.18 ± 0.1 |
Collected over The adverse events are collected while the patients were in the hospital, which was an average of 3 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Depobupivacaine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| OnQ Pump | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Bupivacaine | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(years) | Depobupivacaine | OnQ Pump | Bupivacaine | Total |
|---|---|---|---|---|
| Mean | 52.1 ± 7.1 | 51.33 ± 6.25 | 50 ± 5.7 | 51.12 ± 6.3 |
| Sex: Female, Male(Participants) | Depobupivacaine | OnQ Pump | Bupivacaine | Total |
|---|---|---|---|---|
| Female | 8 | 5 | 8 | 21 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Depobupivacaine | OnQ Pump | Bupivacaine | Total |
|---|---|---|---|---|
| Race white | 8 | 5 | 8 | 21 |
| Region of Enrollment(participants) | Depobupivacaine | OnQ Pump | Bupivacaine | Total |
|---|---|---|---|---|
| United States | 8 | 5 | 8 | 21 |
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Plan to share: No
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