Post-operative Pain Management
Conditions
Brief summary
This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.
Detailed description
The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.
Interventions
DRUGExparel
Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
DRUGBupivacaine
60cc Bupivacaine
Sponsors
Matthew Kroh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* bariatric surgery patients * laparoscopic roux-en-y gastric bypass * use of EEA stapler anastomosis
Exclusion criteria
* age \<18 years * previous history of roux-en-y gastric bypass * patients undergoing other bariatric procedures * pre-operative opioid analgesics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | 24 hours post-surgery | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Operative Pain | 48 hours post-surgery | Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exparel, Liposomal Bupivacaine Subjects in this arm will receive Exparel® liposomal bupivacaine injected concurrently with 0.25% bupivacaine at the incisional sites prior to closing
Exparel: Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine | 50 |
| Control Subjects in this arm will receive 0.25% bupivacaine alone
Bupivacaine: 60cc Bupivacaine | 52 |
| Total | 102 |
Baseline characteristics
| Characteristic | Control | Total | Exparel, Liposomal Bupivacaine |
|---|---|---|---|
| Age, Continuous | 41.2 Years | 44.6 Years | 48.4 Years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 52 participants | 102 participants | 50 participants |
| Sex: Female, Male Female | 42 Participants | 82 Participants | 40 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 52 |
| other Total, other adverse events | 14 / 50 | 27 / 52 |
| serious Total, serious adverse events | 10 / 50 | 15 / 52 |
Outcome results
Primary
Post-Operative Pain
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Time frame: 24 hours post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel, Liposomal Bupivacaine | Post-Operative Pain | 49.4 units on a Visual Analog Scale (VAS) | Standard Deviation 29 |
| Control | Post-Operative Pain | 56.6 units on a Visual Analog Scale (VAS) | Standard Deviation 26.4 |
Secondary
Post-Operative Pain
Patient-reported pain levels, on a 0-100 Visual Analog Scale (VAS) with 0 representing less pain and 100 representing more pain.
Time frame: 48 hours post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exparel, Liposomal Bupivacaine | Post-Operative Pain | 42.2 units on a Visual Analog Scale (VAS) | Standard Deviation 30 |
| Control | Post-Operative Pain | 51.5 units on a Visual Analog Scale (VAS) | Standard Deviation 31.4 |