Labour
Conditions
Keywords
Labour, Epidural analgesia, Clonidine, Levobupivacaine, Opiates, Patient-controlled, Active spontaneous labour requiring epidural analgesia
Brief summary
In a prospective randomised study involving primiparous women in spontaneous uncomplicated labour with cervical dilatation \< 5 cm, epidural analgesia will be given with an initial volume of 20 mL anaesthetic solution, followed by a standardised algorithm of top-up manual injections to achieve analgesia, then by a patient-controlled regimen with 5-mL self-administered boli in addition to a continuous infusion of 5 mL.hr-1. The anaesthetic solution will be levobupivacaine presented in 100-mL bags from the market (0.0625%), in which 10 mL (50 g) of sufentanil will be added, as well as clonidine (150 µg) in one arm. The final concentration of clonidine in this arm will be 1.35 mg.mL-1. Parturients and midwifes assessing pain during labour will be blinded to the design.
Detailed description
We recently compared the analgesic effects of the two presentations of levobupivacaine available on the French market, (0.625 and 1.25 mg.mL-1 in pre-filled bags), both with sufentanil. It appeared that the high concentration was more powerful, however leading in some cases to give doses of levobupivacaine superior to the label's recommendations. This indicates to use the low concentration, with a risk of a poorer efficacy. Our aim is to show that efficacy can be restored with a systematic addition of clonidine, which has documented analgesic properties when administered perispinally.
Interventions
DRUGClonidine
Addition of a non-labeled drug (clonidine) in one of the two arm of the study, with randomisation. To compare the effects of a systematic addition of clonidine (150 µg added in the solution bag) in the local anesthetic solution), versus no addition, on the quality of analgesia for labour.
Sponsors
University Hospital, Clermont-Ferrand
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parturient is 18 years old * ASA physical status 1 or 2 * Primiparity * Singleton * Gestational age is 36 weeks * Spontaneous labour with cervical dilatation of 5 cm
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of required additional epidural boluses, either self-administered or medically given as a rescue | during labour |
Secondary
| Measure | Time frame |
|---|---|
| Pain at delivery | at delivery |
| Pain at post-delivery sutures | at post-delivery sutures |
| Spontaneous pain during labour (on VAS) | during labour |
| Duration of labour | during labour |
| Obstetrical events (caesarean section, instrumental delivery) | after delivery |
| Motor block | during labour |
Countries
France
Outcome results
None listed