Cesarean Section
Conditions
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
40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Chloroprocaine Plasma Concentration at 30 Minutes | 30 minutes after intraperitoneal chloroprocaine administration | The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration. |
| Chloroprocaine Plasma Concentration at 5 Minutes | 5 minutes after intraperitoneal chloroprocaine administration | The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration. |
| Chloroprocaine Plasma Concentration at 10 Minutes | 10 minutes after intraperitoneal chloroprocaine administration | The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration. |
| Chloroprocaine Plasma Concentration at 20 Minutes | 20 minutes after intraperitoneal chloroprocaine administration | The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration. |
| Chloroprocaine Plasma Concentration at 1 Minute | 1 minute after intraperitoneal chloroprocaine administration | The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metallic Taste | within 4 hours of study drug administration | description of metallic taste upon research coordinator query |
| Nausea | Within 4 hours of study drug administration | description of nausea upon research coordinator query |
| Dizziness | Within 4 hours of intraperitoneal chloroprocaine administration | description of dizziness upon research coordinator query |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 15 |
Baseline characteristics
| Characteristic | Preservative Free Chloroprocaine Group 1 | Preservative Free Chloroprocaine Group 2 | Preservative Free Chloroprocaine Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 32.8 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 Participants | 4 Participants | 4 Participants | 12 Participants |
| American Society of Anesthesiologists Physical Status American Society of Anesthesiologists Physical Status 3 | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 3 Participants | 5 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 4 Participants | 13 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 15 participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 1 / 5 | 2 / 5 | 1 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 |
Outcome results
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Chloroprocaine Plasma Concentration at 10 Minutes | 10.4 ng/ml |
| Preservative Free Chloroprocaine Group 2 | Chloroprocaine Plasma Concentration at 10 Minutes | 6.0 ng/ml |
| Preservative Free Chloroprocaine Group 3 | Chloroprocaine Plasma Concentration at 10 Minutes | 217.9 ng/ml |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Chloroprocaine Plasma Concentration at 1 Minute | 14.3 ng/ml |
| Preservative Free Chloroprocaine Group 2 | Chloroprocaine Plasma Concentration at 1 Minute | 7.5 ng/ml |
| Preservative Free Chloroprocaine Group 3 | Chloroprocaine Plasma Concentration at 1 Minute | 3.5 ng/ml |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Chloroprocaine Plasma Concentration at 20 Minutes | 2.2 ng/ml |
| Preservative Free Chloroprocaine Group 2 | Chloroprocaine Plasma Concentration at 20 Minutes | 1.7 ng/ml |
| Preservative Free Chloroprocaine Group 3 | Chloroprocaine Plasma Concentration at 20 Minutes | 3.4 ng/ml |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Chloroprocaine Plasma Concentration at 30 Minutes | 3.4 ng/ml |
| Preservative Free Chloroprocaine Group 2 | Chloroprocaine Plasma Concentration at 30 Minutes | 1.2 ng/ml |
| Preservative Free Chloroprocaine Group 3 | Chloroprocaine Plasma Concentration at 30 Minutes | 3.1 ng/ml |
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Chloroprocaine Plasma Concentration at 5 Minutes | 14.5 ng/ml |
| Preservative Free Chloroprocaine Group 2 | Chloroprocaine Plasma Concentration at 5 Minutes | 14.1 ng/ml |
| Preservative Free Chloroprocaine Group 3 | Chloroprocaine Plasma Concentration at 5 Minutes | 323.1 ng/ml |
Dizziness
description of dizziness upon research coordinator query
Time frame: Within 4 hours of intraperitoneal chloroprocaine administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Dizziness | 1 Participants |
| Preservative Free Chloroprocaine Group 2 | Dizziness | 0 Participants |
| Preservative Free Chloroprocaine Group 3 | Dizziness | 0 Participants |
Metallic Taste
description of metallic taste upon research coordinator query
Time frame: within 4 hours of study drug administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Metallic Taste | 0 Participants |
| Preservative Free Chloroprocaine Group 2 | Metallic Taste | 1 Participants |
| Preservative Free Chloroprocaine Group 3 | Metallic Taste | 0 Participants |
Nausea
description of nausea upon research coordinator query
Time frame: Within 4 hours of study drug administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preservative Free Chloroprocaine Group 1 | Nausea | 0 Participants |
| Preservative Free Chloroprocaine Group 2 | Nausea | 1 Participants |
| Preservative Free Chloroprocaine Group 3 | Nausea | 1 Participants |