Clinical trial NCT00983125: Systematic Clonidine for Epidural Analgesia in Labour
Official title: Effects of a Systematic Addition of Clonidine in the Local Anaesthetic and Opiate Solution for Epidural Patient Controlled Analgesia in Labour (Levobupivacaine 0.568 mg.mLl-1 + Sufentanil 0.45 µg.mL-1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Labour
Keywords: Labour
Epidural analgesia
Clonidine
Levobupivacaine
Opiates
Patient-controlled
Active spontaneous labour requiring epidural analgesia
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2009-09-23
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of required additional epidural boluses, either self-administered or medically given as a rescue
timeFrame: during labour
Secondary outcomes:
measure: Spontaneous pain during labour (on VAS)
timeFrame: during labour
measure: Pain at delivery
timeFrame: at delivery
measure: Pain at post-delivery sutures
timeFrame: at post-delivery sutures
measure: Motor block
timeFrame: during labour
measure: Duration of labour
timeFrame: during labour
measure: Obstetrical events (caesarean section, instrumental delivery)
timeFrame: after delivery
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Martine Bonnin, MB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazin M, Bonnin M, Storme B, Bolandard F, Vernis L, Lavergne B, Pereira B, Bazin JE, Duale C. Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labour. Anaesthesia. 2011 Sep;66(9):769-79. doi: 10.1111/j.1365-2044.2011.06785.x. Epub 2011 Jun 24.