Combined spinal-epidural anaesthesia during labour : has the epidural administration of clonidine and neostigmine a positive influence on the quality of analgesia ?

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005845-12-BE

Enrollment

100

Registered

2006-11-30

Start date

2007-01-08

Completion date

Unknown

Last updated

2021-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

combined spinal-epidural analgesia during labour

Interventions

Trade Name: Prostigmine Pharmaceutical Form: Injection* INN or Proposed INN: neostigmine methylsulfas CAS Number: 51-60-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ASA I or II - Nullipari, vertex presentation - > 37weeks postconception - Normal pregnancy - No suspicion of C-section Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - ASA III and IV - contra indication for regional anesthesia - obesity (BMI >40) - suspicion of congenital disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this trial is to evaluate if epidural administration of clonidine and neostigmine can reduce the incidence of break-through pain during labour. The total amount of the analgesics consumption will also be assessed and an evaluation of patient's satisfaction with their analgesic regimen will be performed.;Secondary Objective: - Evaluation of fetal well-being - Registration of neonatal outcome - Registration of labour time - Registration of adverse events;Primary end point(s): Has the epidural administration of clonidine and neostigmine a positive influence on the quality of analgesia during labour?	—

Measure

Time frame

Main Objective: The objective of this trial is to evaluate if epidural administration of clonidine and neostigmine can reduce the incidence of break-through pain during labour. The total amount of the analgesics consumption will also be assessed and an evaluation of patient's satisfaction with their analgesic regimen will be performed.;Secondary Objective: - Evaluation of fetal well-being - Registration of neonatal outcome - Registration of labour time - Registration of adverse events;Primary end point(s): Has the epidural administration of clonidine and neostigmine a positive influence on the quality of analgesia during labour?

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026