Unplanned Caesarean SectionPhase 3NCT02919072
Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section
A Phase 3 study testing Chloroprocaine and Ropivacaine in people with Unplanned Caesarean Section, run by Sintetica SA at 1 site in Belgium.
Trial summary
The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Unplanned Caesarean Section
- What is being tested?
- Chloroprocaine and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to Jun 2021
- Phase
- Phase 3
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent: Signed written informed consent before inclusion in the study (obtained from women fulfilling the criteria, only when effective analgesia has been established)
- Sex, pregnancy status and age: Labouring women with singleton pregnancy, ≥ 18 years old
- Epidural catheter: Previously sited epidural catheter
- ASA physical status: I-II
- Analgesia: Effective analgesia established following combined spinal epidural analgesia (CSE)
- Term gestation: ≥ 36 weeks
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- Caesarean section: Unplanned Caesarean section category 2 or 3, according to Lucas Classification
- Body Mass Index (BMI): ≤ 40 kg/m2
- Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.
Who cannot join
- Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to epidural anaesthesia
- ASA physical status: III-V
- Further anaesthesia: Patients expected to require further anaesthesia
- Epidural catheter: Epidural catheter failure (epidural catheter replacement required or inability to provide effective analgesia)
- Pregnancy: Labouring women with multiple pregnancy
- Caesarean section: Elective Caesarean section
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- Allergy: ascertained or presumptive hypersensitivity to the active principle and /or formulations ingredients; ascertained or presumptive hypersensitivity to the amide and ester-type anaesthetics
- Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study; ascertained psychiatric diseases, eclampsia, antepartum haemorrhage, sepsis, blood coagulation disorders, insulin dependent diabetes mellitus, terminal kidney failure
- Medications: Medication known to interfere with the extent of regional blocks (see chloroprocaine and ropivacaine SmPCs) for 2 weeks before the start of the study
- Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study, calculated from the first day of the month following the last visit of the previous study
- Drug, alcohol: history of drug or alcohol abuse
- Plasma cholinesterase: Known plasma cholinesterase deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ
The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.
Read the detailed description
Labouring women who have an epidural catheter in situ and established analgesia, in need of an unplanned Caesarean section, will be randomly allocated to receive either Chloroprocaine HCl 3% (T-group) or Ropivacaine HCl 0.75% (R-group) epidurally. Prior to the epidural injection, the patient will be transferred to the operating theatre. The local anaesthetic solution will be freshly prepared and 20 mL will be administered by epidural injection, according to the standard hospital procedures, as detailed in the "Study Schedule" section below. Time T0 is defined as the start time of the first epidural injection of the investigational product. In case of pain or discomfort, a 6 mL epidural top-up of the same anaesthetic, i.e. Chloroprocaine HCl 3% in T-group and Ropivacaine HCl 0.75% in R-group, will be administered. The anaesthesiologist(s) administering the anaesthetic and collecting the data will be blinded with respect to the treatment given to each patient.
- Conditions
- Unplanned Caesarean Section
- Being tested
- Chloroprocaine, Ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroprocaineDrug
Also called Ampres
The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
RopivacaineDrug
Also called Naropin
The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Chloroprocaine | Experimental | Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Receives: Drug: Chloroprocaine |
| Ropivacaine | Active comparator | Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the Onset of Anaesthesia
The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.
Measured: Up to 1 hour after last epidural injection
Secondary outcomes (22)
Time From T0 to Loss Light Touch Sensation
Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral
Measured: Up to 1 hour after last epidural injection
Quality of the Block
Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality)
Measured: Quality of the block assessed between 10 and 20 minutes after the end of surgery
Maximum Metameric Level of the Sensory Block
Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation)
Measured: Up to 1 hrs after last epidural injection
Motor Block Assessment
Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery
Measured: Up to 12 hours after surgery
Proportion of Patients Who Need Top-up Anaesthesia
Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection)
Measured: Up to 2 hours after last epidural injection
Proportion of Patients Who Need Supplementation of Opioids
Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids
Measured: Up to 2 hours after last epidural injection
Proportion of Patients Who Need General Anaesthesia
Proportion of patients who need general anaesthesia
Measured: Up to 2 hours after last epidural injection
Discomfort and Pain During Surgery
Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist
Measured: Up to 2 hours after last epidural injection
First Breakthrough Pain
First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable)
Measured: Up to 12 hours after surgery
Maternal Treatment-emergent Adverse Events
Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting
Measured: Up to day 3±1 after surgery
Pulse Rate
Maternal pulse rate
Measured: Up to 12 hours after surgery
Oximetry
Maternal pulse oximetry (SpO2)
Measured: Up to 12 hours after surgery
Electrocardiogram
Maternal electrocardiogram
Measured: Up to 12 hours after surgery
Total Dose of Phenylephrine
Total dose (μg) of phenylephrine
Measured: Up to 2 hours after last epidural injection
Total Dose of Atropine
Total dose (mg) of atropine
Measured: Up to 2 hours after last epidural injection
Intravenous Fluids
Total volume (ml) of intravenous fluids
Measured: Up to 12 hours after surgery
Neonate Apgar
Neonate Apgar scores at 1 and 5 minutes
Measured: 1 and 5 minutes after birth
Foetal Hypoxic Stress
Indication of foetal hypoxic stress
Measured: Up to 12 hours after surgery
Pain at the Site of Surgery
Pain at the site of surgery at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=most severe pain imaginable)
Measured: Up to 12 hours after surgery
Pain at the Site of Epidural Injection
Pain at the site of epidural injection at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain)
Measured: Up to 12 hours after surgery
Concomitant Medications
Maternal concomitant medications
Measured: Up to day 3±1 after surgery
Neonatal Adverse Events
Neonatal adverse events
Measured: Up to day 3±1 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2021
- Study completionJun 2021
Why it stopped: The doctors involved in the study did not enroll any patients
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.
- Other trials for Unplanned Caesarean SectionStudies of the same condition, open and under way.
- 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sintetica SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Responsible party
- Sponsor
- Investigators
- Marc Van de Velde, MD, Principal investigator, Department of Anesthesiology, UZ Leuven, campus Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919072
- Sponsor's protocol ID
- CHL.3/01-2016
- Status last verified
- Nov 2023
- First submitted
- 29 Aug 2016
- Last updated
- 21 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Chloroprocaine 3% and Ropivacaine 0.75% for Unplanned Caesarean Section in Labouring Women Who Have an Epidural Catheter in Situ
- ClinicalTrials.gov ID
- NCT02919072
- Acronym / sponsor ID
- CHL.3/01-2016
- Conditions
- Unplanned Caesarean Section
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The doctors involved in the study did not enroll any patients
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sintetica SAIndustry (pharma, biotech, devices)
- Collaborators
- Cross Research S.A.
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2021 (actual)
- Study completion
- Jun 2021 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 21 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.
Detailed description
Labouring women who have an epidural catheter in situ and established analgesia, in need of an unplanned Caesarean section, will be randomly allocated to receive either Chloroprocaine HCl 3% (T-group) or Ropivacaine HCl 0.75% (R-group) epidurally. Prior to the epidural injection, the patient will be transferred to the operating theatre. The local anaesthetic solution will be freshly prepared and 20 mL will be administered by epidural injection, according to the standard hospital procedures, as detailed in the "Study Schedule" section below. Time T0 is defined as the start time of the first epidural injection of the investigational product. In case of pain or discomfort, a 6 mL epidural top-up of the same anaesthetic, i.e. Chloroprocaine HCl 3% in T-group and Ropivacaine HCl 0.75% in R-group, will be administered. The anaesthesiologist(s) administering the anaesthetic and collecting the data will be blinded with respect to the treatment given to each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroprocaine | Experimental | Drug: ChloroprocaineChloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. |
| Ropivacaine | Active comparator | Drug: RopivacaineRopivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Informed consent: Signed written informed consent before inclusion in the study (obtained from women fulfilling the criteria, only when effective analgesia has been established)
- Sex, pregnancy status and age: Labouring women with singleton pregnancy, ≥ 18 years old
- Epidural catheter: Previously sited epidural catheter
- ASA physical status: I-II
- Analgesia: Effective analgesia established following combined spinal epidural analgesia (CSE)
Key exclusion criteria (12 listed)
- Physical findings: Clinically significant abnormal physical findings which could interfere with the objectives of the study. Contraindications to epidural anaesthesia
- ASA physical status: III-V
- Further anaesthesia: Patients expected to require further anaesthesia
- Epidural catheter: Epidural catheter failure (epidural catheter replacement required or inability to provide effective analgesia)
- Pregnancy: Labouring women with multiple pregnancy
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 |
|---|---|---|
| ChloroprocaineAlso: AmpresThe 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. | Drug | Chloroprocaine |
| RopivacaineAlso: NaropinThe 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered. | Drug | Ropivacaine |
Primary outcome
Time to the Onset of Anaesthesia
Time frame: Up to 1 hour after last epidural injection
The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.
22 secondary outcomes
Time From T0 to Loss Light Touch Sensation
Time frame: Up to 1 hour after last epidural injection
Quality of the Block
Time frame: Quality of the block assessed between 10 and 20 minutes after the end of surgery
Maximum Metameric Level of the Sensory Block
Time frame: Up to 1 hrs after last epidural injection
Motor Block Assessment
Time frame: Up to 12 hours after surgery
Proportion of Patients Who Need Top-up Anaesthesia
Time frame: Up to 2 hours after last epidural injection
Proportion of Patients Who Need Supplementation of Opioids
Time frame: Up to 2 hours after last epidural injection
Proportion of Patients Who Need General Anaesthesia
Time frame: Up to 2 hours after last epidural injection
Discomfort and Pain During Surgery
Time frame: Up to 2 hours after last epidural injection
First Breakthrough Pain
Time frame: Up to 12 hours after surgery
Maternal Treatment-emergent Adverse Events
Time frame: Up to day 3±1 after surgery
Pulse Rate
Time frame: Up to 12 hours after surgery
Oximetry
Time frame: Up to 12 hours after surgery
Electrocardiogram
Time frame: Up to 12 hours after surgery
Total Dose of Phenylephrine
Time frame: Up to 2 hours after last epidural injection
Total Dose of Atropine
Time frame: Up to 2 hours after last epidural injection
Intravenous Fluids
Time frame: Up to 12 hours after surgery
Neonate Apgar
Time frame: 1 and 5 minutes after birth
Foetal Hypoxic Stress
Time frame: Up to 12 hours after surgery
Pain at the Site of Surgery
Time frame: Up to 12 hours after surgery
Pain at the Site of Epidural Injection
Time frame: Up to 12 hours after surgery
Concomitant Medications
Time frame: Up to day 3±1 after surgery
Neonatal Adverse Events
Time frame: Up to day 3±1 after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Unplanned Caesarean Section
RecruitingObservational study
Predictive Value of Early Peritraumatic Distress Screening for Childbirth-PTSD Following Unplanned Cesarean Delivery
Post Traumatic Stress Disorder, Post Partum Depression
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.
Marc Van de Velde, MD principal investigator
Department of Anesthesiology, UZ Leuven, campus Gasthuisberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chloroprocaine and Ropivacaine in people with Unplanned Caesarean Section, run by Sintetica SA at 1 site in Belgium.
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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 21 Nov 2023. 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 Belgium. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 21 Nov 2023). 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?
Time to the Onset of Anaesthesia (time frame: Up to 1 hour after last epidural injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2023.