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Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03760718
Acronym
CLOR-PRO
Enrollment
15
Registered
2018-11-30
Start date
2019-09-30
Completion date
2021-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

chloroprocaine, cesarean delivery, lavage

Brief summary

The long term objective is to show that intraperitoneal chloroprocaine can be used an alternative option to avoid general anesthesia during cesarean delivery, to alleviate mother's discomfort from surgical pain, reduce complications, and improve the birth experience. The objectives in this study are to determine the amount of chloroprocaine that is absorbed into the blood in order to create a plasma concentration time profile and to determine the incidence of side effects to help guide selection of an appropriate concentration for future study.

Detailed description

Compared to general anesthesia, neuraxial anesthesia (spinals and epidurals) is associated with a lower risk for maternal aspiration and airway compromise, exposes the baby to less anesthetic, and allows for greater maternal involvement in the birth process. For these reasons, it has become the preferred method of anesthesia for cesarean delivery. Spinals that are placed to facilitate cesarean delivery have a duration of one to two hours. Currently, if that duration is exceeded patients must have general endotracheal anesthesia. In addition, suboptimal neuraxial anesthesia for cesarean delivery is not uncommon with an incidence of 2-9%, depending upon the urgency of surgery and the type of neuraxial block. Providing less than adequate anesthesia for cesarean delivery may increase the risk of legal liability. For this reason, some patients with suboptimal neuraxial anesthesia have intraoperative conversion to general endotracheal anesthesia. The first known description of the use of intraperitoneal local anesthetic to provide anesthesia for cesarean delivery was published in 1975. In this article Ranney et al. described how to use up to 100 mL of 1% procaine to provide anesthesia for cesarean delivery under local field block alone. Some of this was injected into the skin and fascia, and the remainder was diluted to 0.5% and spilled into the peritoneum. Multiple publications have shown that intraperitoneal local anesthetic can be used to treat intraoperative and postoperative pain, prevent postoperative nausea, and shorten hospital length of stay. A recently published 40-month case series showed that chloroprocaine lavage can be used as part of a multimodal approach to treating intraoperative pain. In this case series, the technique of chloroprocaine lavage helped investigators to avoid general endotracheal anesthesia in 32 women having a cesarean delivery. In this case series, no patients exhibited clinical signs of systemic local anesthetic toxicity. It is believed that chloroprocaine has a limited potential for toxicity because of its short plasma half-life, which is only 11-21 seconds. The purpose of this study is to determine the amount of chloroprocaine that is taken up into the blood stream after intraperitoneal administration to ensure that blood levels are low and do not raise a safety concern. Data obtained from this study will help to define a safe dose of chloroprocaine for intraperitoneal administration.

Interventions

DRUGPreservative free 1% Chloroprocaine

40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

DRUGPreservative free 2% Chloroprocaine

40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

DRUGPreservative free 3% Chloroprocaine

40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Subjects ≥ 18 to 50 years of age having scheduled cesarean sections on 12C (Labor and Delivery) within Oregon Health & Science University (OHSU). * Only subjects having spinal anesthesia will be eligible. * Only subjects that can have a Pfannenstiel incision will be enrolled.

Exclusion criteria

* Subjects with chronic narcotic usage * Subjects that are deemed to need a combined spinal epidural for any reason. * Subjects who are unable to successfully get a spinal block * Subjects with known atypical cholinesterase activity * American Society of Anesthesiologist physical status IV or higher * Subjects with contraindication to neuraxial anesthesia (coagulopathy, infection) * Subjects with stage 4 chronic kidney disease or worse (eGFR \< 30 ml/min) * Subjects with significant hepatic dysfunction (AST or ALT \> 2x the upper limit of normal) * Subjects with allergies to drugs required for this protocol. * Subjects with multifetal gestations * Subjects with a BMI \> 40 kg/m2

Design outcomes

Primary

MeasureTime frameDescription
Chloroprocaine Plasma Concentration at 30 Minutes30 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.
Chloroprocaine Plasma Concentration at 5 Minutes5 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.
Chloroprocaine Plasma Concentration at 10 Minutes10 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.
Chloroprocaine Plasma Concentration at 20 Minutes20 minutes after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.
Chloroprocaine Plasma Concentration at 1 Minute1 minute after intraperitoneal chloroprocaine administrationThe chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.

Other

MeasureTime frameDescription
Metallic Tastewithin 4 hours of study drug administrationdescription of metallic taste upon research coordinator query
NauseaWithin 4 hours of study drug administrationdescription of nausea upon research coordinator query
DizzinessWithin 4 hours of intraperitoneal chloroprocaine administrationdescription of dizziness upon research coordinator query

Countries

United States

Participant flow

Participants by arm

ArmCount
Preservative Free Chloroprocaine Group 1
40 ml of preservative-free 1% chloroprocaine Preservative free 1% Chloroprocaine: 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
5
Preservative Free Chloroprocaine Group 2
40 ml of preservative-free 2% chloroprocaine Preservative free 2% Chloroprocaine: 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
5
Preservative Free Chloroprocaine Group 3
40 ml of preservative-free 3% chloroprocaine Preservative free 3% Chloroprocaine: 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
5
Total15

Baseline characteristics

CharacteristicPreservative Free Chloroprocaine Group 1Preservative Free Chloroprocaine Group 2Preservative Free Chloroprocaine Group 3Total
Age, Continuous32.8 years
STANDARD_DEVIATION 6.4
34.8 years
STANDARD_DEVIATION 3.8
34 years
STANDARD_DEVIATION 5.3
33.9 years
STANDARD_DEVIATION 5
American Society of Anesthesiologists Physical Status
American Society of Anesthesiologists Physical Status 2
4 Participants4 Participants4 Participants12 Participants
American Society of Anesthesiologists Physical Status
American Society of Anesthesiologists Physical Status 3
1 Participants1 Participants1 Participants3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
5 Participants3 Participants5 Participants13 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants4 Participants4 Participants13 Participants
Region of Enrollment
United States
5 participants5 participants5 participants15 participants
Sex: Female, Male
Female
5 Participants5 Participants5 Participants15 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 50 / 5
other
Total, other adverse events
1 / 52 / 51 / 5
serious
Total, serious adverse events
0 / 50 / 50 / 5

Outcome results

Primary

Chloroprocaine Plasma Concentration at 10 Minutes

The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration.

Time frame: 10 minutes after intraperitoneal chloroprocaine administration

ArmMeasureValue (MEAN)
Preservative Free Chloroprocaine Group 1Chloroprocaine Plasma Concentration at 10 Minutes10.4 ng/ml
Preservative Free Chloroprocaine Group 2Chloroprocaine Plasma Concentration at 10 Minutes6.0 ng/ml
Preservative Free Chloroprocaine Group 3Chloroprocaine Plasma Concentration at 10 Minutes217.9 ng/ml
Primary

Chloroprocaine Plasma Concentration at 1 Minute

The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.

Time frame: 1 minute after intraperitoneal chloroprocaine administration

ArmMeasureValue (MEAN)
Preservative Free Chloroprocaine Group 1Chloroprocaine Plasma Concentration at 1 Minute14.3 ng/ml
Preservative Free Chloroprocaine Group 2Chloroprocaine Plasma Concentration at 1 Minute7.5 ng/ml
Preservative Free Chloroprocaine Group 3Chloroprocaine Plasma Concentration at 1 Minute3.5 ng/ml
Primary

Chloroprocaine Plasma Concentration at 20 Minutes

The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration.

Time frame: 20 minutes after intraperitoneal chloroprocaine administration

ArmMeasureValue (MEAN)
Preservative Free Chloroprocaine Group 1Chloroprocaine Plasma Concentration at 20 Minutes2.2 ng/ml
Preservative Free Chloroprocaine Group 2Chloroprocaine Plasma Concentration at 20 Minutes1.7 ng/ml
Preservative Free Chloroprocaine Group 3Chloroprocaine Plasma Concentration at 20 Minutes3.4 ng/ml
Primary

Chloroprocaine Plasma Concentration at 30 Minutes

The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.

Time frame: 30 minutes after intraperitoneal chloroprocaine administration

ArmMeasureValue (MEAN)
Preservative Free Chloroprocaine Group 1Chloroprocaine Plasma Concentration at 30 Minutes3.4 ng/ml
Preservative Free Chloroprocaine Group 2Chloroprocaine Plasma Concentration at 30 Minutes1.2 ng/ml
Preservative Free Chloroprocaine Group 3Chloroprocaine Plasma Concentration at 30 Minutes3.1 ng/ml
Primary

Chloroprocaine Plasma Concentration at 5 Minutes

The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration.

Time frame: 5 minutes after intraperitoneal chloroprocaine administration

ArmMeasureValue (MEAN)
Preservative Free Chloroprocaine Group 1Chloroprocaine Plasma Concentration at 5 Minutes14.5 ng/ml
Preservative Free Chloroprocaine Group 2Chloroprocaine Plasma Concentration at 5 Minutes14.1 ng/ml
Preservative Free Chloroprocaine Group 3Chloroprocaine Plasma Concentration at 5 Minutes323.1 ng/ml
Other Pre-specified

Dizziness

description of dizziness upon research coordinator query

Time frame: Within 4 hours of intraperitoneal chloroprocaine administration

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Preservative Free Chloroprocaine Group 1Dizziness1 Participants
Preservative Free Chloroprocaine Group 2Dizziness0 Participants
Preservative Free Chloroprocaine Group 3Dizziness0 Participants
Other Pre-specified

Metallic Taste

description of metallic taste upon research coordinator query

Time frame: within 4 hours of study drug administration

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Preservative Free Chloroprocaine Group 1Metallic Taste0 Participants
Preservative Free Chloroprocaine Group 2Metallic Taste1 Participants
Preservative Free Chloroprocaine Group 3Metallic Taste0 Participants
Other Pre-specified

Nausea

description of nausea upon research coordinator query

Time frame: Within 4 hours of study drug administration

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Preservative Free Chloroprocaine Group 1Nausea0 Participants
Preservative Free Chloroprocaine Group 2Nausea1 Participants
Preservative Free Chloroprocaine Group 3Nausea1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026