Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control
Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Objective The objective of this study is to test the hypothesis that instillation of
intra-abdominal chloroprocaine during cesarean deliveries is associated with decreased
postoperative pain and nausea compared to placebo, without increasing intraoperative and
postoperative complications.
Methods The investigators plan to randomize about 150 women undergoing primary and repeat
cesarean deliveries to intra-abdominal chloroprocaine versus placebo prior to abdominal
closure. Women will be excluded if they have ascertained or presumptive hypersensitivity to
the ester type and major anesthetics; if they have chronic pelvic pain or if they refuse to
participate in the study. The investigators' primary outcome measure will be postoperative
pain as measured by visual analogue scale (VAS) at 1 hour after skin closure. Secondary
outcomes will include objective pain as measured by VAS at 2, 6, 24 and 48 hours at rest and
during mobilization, adverse effects of chloroprocaine (gastrointestinal side effects,
pruritus), concomitant analgesic requirement, hospital readmissions and length of hospital
stay. Analysis will follow the intention-to-treat principle.
The investigators will also be studying the concentration/effect (PKPD) relationship of
chloroprocaine use for pain control in the postpartum period. The time courses of the plasma
concentrations of chloroprocaine will be analyzed with mixed effects
pharmacokinetic-pharmacodynamic (PKPD).