Pain, Postoperative
Conditions
Keywords
local anesthetic continuous infusion pump, local injection of Exparel
Brief summary
Effective post surgical pain control in patients undergoing unilateral deep inferior epigastric perforator (DIEP) free flap reconstruction.
Detailed description
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.
Interventions
DRUGDepobupivacaine
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.
DRUGOnQ 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.
group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non pregnant women * age 18 years or older * scheduled to have unilateral DIEP flap breast reconstruction. * Must have ASA physical status classification of 1,2, or 3
Exclusion criteria
* concurrent or recent medical condition that could interfere with study participation * history of any of the following: * hepatitis * alcohol/substance abuse * uncontrolled psychiatric disorders * known allergy/ contraindication to any of the following: * amide-type local anesthetics * opioids * propofol * Body weight of less than 50 kg * have participated in another study involving an investigational medication with in the past 30 days * taking analgesics, antidepressants, or glucocorticoids within the 3 days before surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Narcotic Usage | total hospital stay, an average of 3 days | Post-op pain measured by total post-op Morphine equivalents |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 8 |
| 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. | 5 |
| 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. | 8 |
| Total | 21 |
Baseline characteristics
| Characteristic | Depobupivacaine | OnQ Pump | Bupivacaine | Total |
|---|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 7.1 | 51.33 years STANDARD_DEVIATION 6.25 | 50 years STANDARD_DEVIATION 5.7 | 51.12 years STANDARD_DEVIATION 6.3 |
| Race/Ethnicity, Customized Race white | 8 participants | 5 participants | 8 participants | 21 participants |
| Region of Enrollment United States | 8 participants | 5 participants | 8 participants | 21 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 5 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 5 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 5 | 0 / 8 |
Outcome results
Primary
Total Narcotic Usage
Post-op pain measured by total post-op Morphine equivalents
Time frame: total hospital stay, an average of 3 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Depobupivacaine | Total Narcotic Usage | 0.8 mg/kg/day morphine | Standard Deviation 0.5 |
| OnQ Pump | Total Narcotic Usage | .13 mg/kg/day morphine | Standard Deviation 0.1 |
| Bupivacaine | Total Narcotic Usage | 0.18 mg/kg/day morphine | Standard Deviation 0.1 |