Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/27/2018 |
| Start Date: | June 1, 2017 |
| End Date: | December 31, 2019 |
| Contact: | Linda Libertini |
| Email: | libertl@ccf.org |
| Phone: | 216-445-4148 |
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.
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.
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.
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.
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
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