Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler
Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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.