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Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

NCT03260972 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-09-29

No results posted yet for this study

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).

Conditions

  • Cesarean Section Complications
  • Pain

Interventions

DRUG

Chloroprocaine Hcl 2% Inj

20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.

DRUG

Normal saline

20 mls of normal saline will be instilled into the abdomen prior to fascia closure.

Sponsors & Collaborators

Principal Investigators

  • Ahizechukwu Eke, MD MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-04-30
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03260972 on ClinicalTrials.gov