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Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

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ClinicalTrials.gov Identifier: NCT03260972
Recruitment Status : Not yet recruiting
First Posted : August 24, 2017
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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).


Condition or disease Intervention/treatment Phase
Cesarean Section Complications Pain Drug: Chloroprocaine Hcl 2% Inj Drug: Normal saline Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients admitted for cesarean section and meeting inclusion criteria will be approached for consent. Consented patients will then be randomized into two groups.

Group 1: (intraabdominal chloroprocaine administration): These participants will have intraabdominal chloroprocaine administration at the time of cesarean section before fascial closure.

Group 2: (Intraabdominal instillation of placebo (sterile water): These participants will have placebo (normal saline) administered at the time of cesarean section before fascial closure. Cesarean section will proceed traditionally, including fascial and skin closure.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: The investigator and patients will be masked from the treatment options. The care providers will not be masked.
Primary Purpose: Treatment
Official Title: An Evaluation of Intraabdominal Chloroprocaine During Cesarean Delivery and Its Effect on Postoperative Pain and Nausea; a Randomized Controlled Trial & Pharmacokinetic-pharmacodynamics (PKPD) Analysis.
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: Chloroprocaine arm
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: 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.
Other Name: Nesacaine

Placebo Comparator: Normal saline arm
20 mls of normal saline 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.




Primary Outcome Measures :
  1. Visual analogue scale (VAS) at 1 hour after skin closure [ Time Frame: Immediately following cesarean section to 1 hour after skin closure ]
    Our primary outcome measure will be postoperative pain as measured by visual analogue scale (VAS) at 1 hours after skin closure (sitting in an upright position and movement of lower extremities) after cesarean section. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.


Secondary Outcome Measures :
  1. Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization [ Time Frame: 2, 6, 24 and 48 hours after cesarean section ]
    Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization. The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient selects a whole number (0-10 integers) that best reflects the intensity of their pain, with 0 being the best pain and 10 being the worst pain.

  2. Adverse effects of chloroprocaine (gastrointestinal side effects, pruritus) [ Time Frame: Day 0 to 2 weeks after delivery ]
    An adverse effect is an undesired harmful effect resulting from chloroprocaine use. Adverse effects of chloroprocaine include gastrointestinal (nausea, vomiting), dizziness, rash, itching, redness and anxiety.

  3. Concomitant analgesic requirement [ Time Frame: Day 0 to 4 weeks after delivery ]
    The patients will be evaluated for increased analgesic requirement after use of chloroprocaine or placebo. The total amount of analgesia used will be recorded.

  4. Hospital readmissions for pain [ Time Frame: Day 0 to 6 weeks after delivery ]
    A hospital readmission for pain is an episode when a patient who had been adequately pain controlled is discharged from a hospital is admitted again within a specified time interval for poor pain control.

  5. Length of hospital stay [ Time Frame: Day 0 to 1 week after delivery ]
    This is defined as the number of days the patient stays in the hospital after cesarean section.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women with a singleton or multiple pregnancies, vertex or breech presentation presenting to our labor and delivery unit for an elective cesarean section will be eligible for participation.

Exclusion Criteria:

  • Women will be excluded if any of the following criteria are encountered: Allergy against local anesthetics - ascertained or presumptive hypersensitivity to the ester type and major anesthetics; chronic pelvic pain and refusal to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260972


Contacts
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Contact: Ahizechukwu C Eke, MD MPH (410) 504-7454 aeke2@jhu.edu
Contact: Clark T Johnson, MD MPH 4109558496 ctj@jhu.edu

Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Clark T Johnson, MD MPH Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03260972     History of Changes
Other Study ID Numbers: IRB00129099
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No personal patient data will be shared with other researchers. The final de-identified manuscript will be published.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chloroprocaine
Procaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents