Systematic Clonidine for Epidural Analgesia in Labour

NCT00983125 | Completed Phase 4

• 1 other identifier: CHU-0058
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Labour

Keywords

Labour; Epidural analgesia; Clonidine; Levobupivacaine; Opiates; Patient-controlled; Active spontaneous labour requiring epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Number of required additional epidural boluses, either self-administered or medically given as a rescue

  during labour

Secondary Outcomes (6)

• Spontaneous pain during labour (on VAS)

  during labour

• Pain at delivery

  at delivery

• Pain at post-delivery sutures

  at post-delivery sutures

• Motor block

  during labour

• Duration of labour

  during labour

Study Arms (2)

clonidine

EXPERIMENTAL

Drug: Clonidine

no clonidine

OTHER

Drug: Clonidine

Interventions

Clonidine DRUG

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.

clonidine; no clonidine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 21707560 RESULT

Related Links

• Related Info

MeSH Terms

Interventions

Clonidine

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Martine Bonnin, MB

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2009
• First Posted: September 23, 2009
• Study Start: August 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

FR (1)