Intraabdominal Chloroprocaine During Cesarean Delivery for Pain Control

NCT03260972 | Withdrawn Phase 3 DMC

• 1 other identifier: IRB00129099
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Cesarean Section Complications; Pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) at 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.

  Immediately following cesarean section to 1 hour after skin closure

Secondary Outcomes (5)

• Visual analogue scale (VAS) at 2, 6, 24 and 48 hours at rest and during mobilization

  2, 6, 24 and 48 hours after cesarean section

• Adverse effects of chloroprocaine (gastrointestinal side effects, pruritus)

  Day 0 to 2 weeks after delivery

• Concomitant analgesic requirement

  Day 0 to 4 weeks after delivery

• Hospital readmissions for pain

  Day 0 to 6 weeks after delivery

• Length of hospital stay

  Day 0 to 1 week after delivery

Study Arms (2)

Chloroprocaine arm

ACTIVE COMPARATOR

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

Normal saline arm

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Chloroprocaine Hcl 2% Inj DRUG

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.

Also known as: Nesacaine

Chloroprocaine arm

Normal saline DRUG

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

Normal saline arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Pain

Interventions

chloroprocaine; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ahizechukwu Eke, MD MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator and patients will be masked from the treatment options. The care providers will not be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 22, 2017
• First Posted: August 24, 2017
• Study Start: June 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share