Cesarean SectionEarly Phase 1CLOR-PRONCT03760718
Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
A Early Phase 1 study testing Preservative free 1% Chloroprocaine, Preservative free 2% Chloroprocaine and Preservative free 3% Chloroprocaine in people with Cesarean Section, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Preservative free 1% Chloroprocaine, Preservative free 2% Chloroprocaine and Preservative free 3% Chloroprocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 31 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Labor and Delivery; Oregon Health and Science University Hospital
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Cesarean Section
- Being tested
- Preservative free 1% Chloroprocaine, Preservative free 2% Chloroprocaine, Preservative free 3% Chloroprocaine
- Keywords
- chloroprocaine, cesarean delivery, lavage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservative free 1% ChloroprocaineDrug
Also called Nesacaine
40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
Preservative free 2% ChloroprocaineDrug
Also called Nesacaine
40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
Preservative free 3% ChloroprocaineDrug
Also called Nesacaine
40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
| Study group | Role | What they receive |
|---|---|---|
| Preservative free Chloroprocaine Group 1 | Active comparator | 40 ml of preservative-free 1% chloroprocaine Receives: Drug: Preservative free 1% Chloroprocaine |
| Preservative free Chloroprocaine Group 2 | Active comparator | 40 ml of preservative-free 2% chloroprocaine Receives: Drug: Preservative free 2% Chloroprocaine |
| Preservative free Chloroprocaine Group 3 | Active comparator | 40 ml of preservative-free 3% chloroprocaine Receives: Drug: Preservative free 3% Chloroprocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chloroprocaine Plasma Concentration at 1 Minute
The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 minutes after intraperitoneal chloroprocaine administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start30 Sep 2019
- Primary completion17 Sep 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon M Togioka, Oregon Health and Science University
- Investigators
- Brandon M Togioka, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760718
- Sponsor's protocol ID
- 19021
- Acronym
- CLOR-PRO
- Status last verified
- Apr 2024
- First submitted
- 9 Nov 2018
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.
PubMed 1118089Togioka 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.
PubMed 35544759
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chloroprocaine Lavage to Improve Outcomes Related to Operative Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03760718
- Acronym / sponsor ID
- CLOR-PRO / 19021
- Conditions
- Cesarean Section
- Keywords
- chloroprocaine, cesarean delivery, lavage
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 30 Nov 2018 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preservative free Chloroprocaine Group 1 | Active comparator | Drug: Preservative free 1% Chloroprocaine40 ml of preservative-free 1% chloroprocaine |
| Preservative free Chloroprocaine Group 2 | Active comparator | Drug: Preservative free 2% Chloroprocaine40 ml of preservative-free 2% chloroprocaine |
| Preservative free Chloroprocaine Group 3 | Active comparator | Drug: Preservative free 3% Chloroprocaine40 ml of preservative-free 3% chloroprocaine |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative free 1% ChloroprocaineAlso: Nesacaine40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. | Drug | Preservative free Chloroprocaine Group 1 |
| Preservative free 2% ChloroprocaineAlso: Nesacaine40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. | Drug | Preservative free Chloroprocaine Group 2 |
| Preservative free 3% ChloroprocaineAlso: Nesacaine40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby. | Drug | Preservative free Chloroprocaine Group 3 |
Primary outcome
Chloroprocaine Plasma Concentration at 1 Minute
Time frame: 1 minute after intraperitoneal chloroprocaine administration
The chloroprocaine plasma concentration obtained from a venous sample 1 minute after intraperitoneal chloroprocaine administration.
Chloroprocaine Plasma Concentration at 5 Minutes
Time frame: 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
Time frame: 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
Time frame: 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 30 Minutes
Time frame: 30 minutes after intraperitoneal chloroprocaine administration
The chloroprocaine plasma concentration obtained from a venous sample 30 minutes after intraperitoneal chloroprocaine administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 1118089Ranney B, Stanage WF. Advantages of local anesthesia for cesarean section. Obstet Gynecol. 1975 Feb;45(2):163-7.
- Derived from this study: PubMed 35544759Togioka 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.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Esketamine Combined With Transcutaneous Electrical Acupoint Stimulation on Postoperative Recovery Quality After Elective Cesarean Section
Cesarean Section (MeSH: D002585), Postoperative Pain After Cesarean Section
Not yet recruitingObservational study
Early Heart Rate Variability and Sleep and Quality of Recovery After Cesarean Delivery
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brandon M Togioka, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Preservative free 1% Chloroprocaine, Preservative free 2% Chloroprocaine and Preservative free 3% Chloroprocaine in people with Cesarean Section, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chloroprocaine Plasma Concentration at 1 Minute (time frame: 1 minute after intraperitoneal chloroprocaine administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03760718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.