Labour Clinical Trial
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)
Verified date | April 2013 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 124 |
Est. completion date | March 2010 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Bazin M, Bonnin M, Storme B, Bolandard F, Vernis L, Lavergne B, Pereira B, Bazin JE, Dualé C. Addition of clonidine to a continuous patient-controlled epidural infusion of low-concentration levobupivacaine plus sufentanil in primiparous women during labou — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of required additional epidural boluses, either self-administered or medically given as a rescue | during labour | Yes | |
Secondary | Spontaneous pain during labour (on VAS) | during labour | Yes | |
Secondary | Pain at delivery | at delivery | Yes | |
Secondary | Pain at post-delivery sutures | at post-delivery sutures | Yes | |
Secondary | Motor block | during labour | Yes | |
Secondary | Duration of labour | during labour | Yes | |
Secondary | Obstetrical events (caesarean section, instrumental delivery) | after delivery | Yes |
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