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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservative free Chloroprocaine Group 1 | Active Comparator | 40 ml of preservative-free 1% chloroprocaine |
|
| Preservative free Chloroprocaine Group 2 | Active Comparator | 40 ml of preservative-free 2% chloroprocaine |
|
| Preservative free Chloroprocaine Group 3 | Active Comparator | 40 ml of preservative-free 3% chloroprocaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservative free 1% Chloroprocaine | Drug | 40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Chloroprocaine Plasma Concentration at 1 Minute | The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration. | 1 minute after intraperitoneal chloroprocaine administration |
| Chloroprocaine Plasma Concentration at 5 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration. | 5 minutes after intraperitoneal chloroprocaine administration |
| Chloroprocaine Plasma Concentration at 10 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration. | 10 minutes after intraperitoneal chloroprocaine administration |
| Chloroprocaine Plasma Concentration at 20 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration. | 20 minutes after intraperitoneal chloroprocaine administration |
| Chloroprocaine Plasma Concentration at 30 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration. | 30 minutes after intraperitoneal chloroprocaine administration |
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| Measure | Description | Time Frame |
|---|---|---|
| Dizziness | description of dizziness upon research coordinator query | Within 4 hours of intraperitoneal chloroprocaine administration |
| Metallic Taste | description of metallic taste upon research coordinator query |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon M Togioka, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Labor and Delivery; Oregon Health and Science University Hospital | Portland | Oregon | 97239 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1118089 | Background | Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7. | |
| 35544759 | Derived | Togioka BM, Zarnegarnia Y, Bleyle LA, Koop D, Brookfield K, Yanez ND, Treggiari MM. Pharmacokinetics and Tolerability of Intraperitoneal Chloroprocaine After Fetal Extraction in Women Undergoing Cesarean Delivery. Anesth Analg. 2022 Oct 1;135(4):777-786. doi: 10.1213/ANE.0000000000006064. Epub 2022 May 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Preservative Free Chloroprocaine Group 1 | 40 ml of preservative-free 1% chloroprocaine administered into the peritoneal cavity after delivery of the baby |
| FG001 | Preservative Free Chloroprocaine Group 2 | 40 ml of preservative-free 2% chloroprocaine administered into the peritoneal cavity after delivery of the baby |
| FG002 | Preservative Free Chloroprocaine Group 3 | 40 ml of preservative-free 3% chloroprocaine administered into the peritoneal cavity after delivery of the baby |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Preservative Free Chloroprocaine Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chloroprocaine Plasma Concentration at 1 Minute | The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration. | Posted | Mean | 95% Confidence Interval | ng/ml | 1 minute after intraperitoneal chloroprocaine administration |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon Togioka, MD | Oregon Health & Science University | 503-494-4572 | togioka@ohsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2018 | Oct 5, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C004616 | chloroprocaine |
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|
| Preservative free 2% Chloroprocaine | Drug | 40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. |
|
|
| Preservative free 3% Chloroprocaine | Drug | 40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. |
|
|
| within 4 hours of study drug administration |
| Nausea | description of nausea upon research coordinator query | Within 4 hours of study drug administration |
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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists Physical Status | American Society of Anesthesiologist Physical Status 1 (healthiest/lowest risk patient): A normal healthy patient with no acute or chronic diseases. American Society of Anesthesiologist Physical Status 2 (middle risk patient): A patient with mild systemic disease that does not cause functional limitations. American Society of Anesthesiologist Physical Status 3 (least healthy/highest risk patient in the study): A patient with severe systemic disease that causes substantial functional limitations | Count of Participants | Participants |
|
| OG002 | 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. |
|
|
| Primary | Chloroprocaine Plasma Concentration at 5 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 5 minutes after intraperitoneal chloroprocaine administration. | Posted | Mean | 95% Confidence Interval | ng/ml | 5 minutes after intraperitoneal chloroprocaine administration |
|
|
|
| Primary | Chloroprocaine Plasma Concentration at 10 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 10 minutes after intraperitoneal chloroprocaine administration. | Posted | Mean | 95% Confidence Interval | ng/ml | 10 minutes after intraperitoneal chloroprocaine administration |
|
|
|
| Primary | Chloroprocaine Plasma Concentration at 20 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 20 minutes after intraperitoneal chloroprocaine administration. | Posted | Mean | 95% Confidence Interval | ng/ml | 20 minutes after intraperitoneal chloroprocaine administration |
|
|
|
| Primary | Chloroprocaine Plasma Concentration at 30 Minutes | The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration. | Posted | Mean | 95% Confidence Interval | ng/ml | 30 minutes after intraperitoneal chloroprocaine administration |
|
|
|
| Other Pre-specified | Dizziness | description of dizziness upon research coordinator query | Posted | Count of Participants | Participants | Within 4 hours of intraperitoneal chloroprocaine administration |
|
|
|
| Other Pre-specified | Metallic Taste | description of metallic taste upon research coordinator query | Posted | Count of Participants | Participants | within 4 hours of study drug administration |
|
|
|
| Other Pre-specified | Nausea | description of nausea upon research coordinator query | Posted | Count of Participants | Participants | Within 4 hours of study drug administration |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | 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. | 0 | 5 | 0 | 5 | 2 | 5 |
| EG002 | 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. | 0 | 5 | 0 | 5 | 1 | 5 |
| metallic taste | Nervous system disorders | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
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