Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

NCT02919072 | Terminated Phase 3 Results

• 1 other identifier: CHL.3/01-2016
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Unplanned Caesarean Section

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 1 hour after last epidural injection

Secondary Outcomes (22)

• Time From T0 to Loss Light Touch Sensation

  Up to 1 hour after last epidural injection

• Quality of the Block

  Quality of the block assessed between 10 and 20 minutes after the end of surgery

• Maximum Metameric Level of the Sensory Block

  Up to 1 hrs after last epidural injection

• Motor Block Assessment

  Up to 12 hours after surgery

• Proportion of Patients Who Need Top-up Anaesthesia

  Up to 2 hours after last epidural injection

Study Arms (2)

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.

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.

Drug: Ropivacaine

Interventions

Chloroprocaine DRUG

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.

Also known as: Ampres

Chloroprocaine

Ropivacaine DRUG

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.

Also known as: Naropin

Ropivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sintetica SA: lead
• Cross Research S.A.: collaborator

Study Sites (1)

UZ Leuven, campus Gasthuisberg

Leuven, 3000, Belgium

Location

MeSH Terms

Interventions

chloroprocaine; Ropivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Anna Guaita
• Organization: Sintetica SA

aguaita@sintetica.com

+41 (0)91640 42 50

Study Officials

• Marc Van de Velde, MD

  Department of Anesthesiology, UZ Leuven, campus Gasthuisberg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 29, 2016
• Study Start: October 1, 2016
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 21, 2023
• Results First Posted: November 21, 2023

Record last verified: 2023-11

Locations

BE (1)