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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clonidine | Experimental |
| |
| no clonidine | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of required additional epidural boluses, either self-administered or medically given as a rescue | during labour |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous pain during labour (on VAS) | during labour | |
| Pain at delivery | at delivery | |
| Pain at post-delivery sutures |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martine Bonnin, MB | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21707560 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003000 | Clonidine |
| ID | Term |
|---|---|
| D048288 | Imidazolines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| at post-delivery sutures |
| Motor block | during labour |
| Duration of labour | during labour |
| Obstetrical events (caesarean section, instrumental delivery) | after delivery |
| D006571 |
| Heterocyclic Compounds |