Effects of a continuous low-dose clonidine epidural regimen on pain, satisfaction and adverse events during labour: a randomized, double-blind, placebo-controlled trial

Wallet, Florent; Clement, Henri Jacques; Bouret, Carine; Lopez, Felix; Broisin, Françoise; Pignal, Corine; Schoeffler, Mathieu; Derre, Edith; Charpiat, Bruno; Huissoud, Cyril; Aubrun, Frédéric; Viale, Jean Paul

European Journal of Anaesthesiology: May 2010 - Volume 27 - Issue 5 - p 441–447
doi: 10.1097/EJA.0b013e3283365944
Postoperative Pain

Background and objective: Epidural clonidine has been proposed as an adjunct for anaesthetic mixtures during labour. Administered as a bolus, clonidine may have side effects such as sedation and hypotension; its continuous infusion could be attractive in this respect. We, therefore, conducted a randomized, double-blind trial using patient-controlled epidural analgesia with a background infusion using a low dose of clonidine during labour.

Methods: A total of 128 healthy parturients in active labour received a patient-controlled epidural analgesia solution of 0.0625% levobupivacaine and sufentanil 0.25 μg ml−1 with or without clonidine 2 μg ml−1. Ninety-five parturients were analysed. The pain score over time was evaluated as well as drug volume utilization; supplementation bolus and side effects were recorded. The primary endpoint was maternal satisfaction [ClinicalTrials.gov Identifier (NCT00437996)].

Results: Three patients in the control group failed to achieve satisfactory epidural analgesia owing to a technical issue. Although the primary endpoint was not statistically significant, analgesia was more pronounced and obtained earlier in the clonidine group. The area under the curve for the visual analogue pain score was significantly lower in the clonidine group. In this group, hourly doses of levobupivacaine and sufentanil were reduced (13.9 ± 4.3 vs. 16.3 ml ± 4.0; P = 0.005) as well as rescue supplementation and pruritus incidence (18 vs. 46%; P = 0.004). Maternal blood pressure was significantly lower, over time, in the clonidine group but remained within the normal range. Sedation was similar in both groups (4.3 vs. 2.0%; not significant).

Conclusion: The addition of clonidine to epidural levobupivacaine and sufentanil for patient-controlled epidural analgesia in labour improved analgesia, reduced the supplementation rate and reduced pruritus without improvement in maternal satisfaction. Blood pressure was significantly lower in the clonidine group over time but without clinical consequence.

From the Department of Anaesthesiology, Université de Lyon, Hospices Civils de Lyon, Hôpital Croix Rousse, Service d'Anesthésie Réanimation (FW, HJC, FL, FB, CP, MS, ED, FA, JPV), Department of Pharmacy, Université de Lyon, Hospices Civils de Lyon, Hôpital de la Croix Rousse, Lyon (CB, BC), Obstetrical Department, Université de Lyon, Hospices Civils de Lyon, Hôpital Croix Rousse, Service d'Obstétrique (CH), Inserm, EA4173 ERI 22, Agressions vasculaires et réponses tissulaires, UCBLyon1, Université de Lyon, Lyon (JPV) and Department of Anaesthesiology, Université Pierre et Marie Curie, Assistance Publique Hôpitaux de Paris, Hôpital Pitié Salpétrière, Service d'Anesthésie Réanimation, Paris, France (FA)

Received 20 August, 2009

Revised 28 November, 2009

Accepted 6 December, 2009

Correspondence to Dr Henri Jacques Clement, Service d'Anesthésie Reanimation, Hospices Civils de Lyon, CHU de la Croix Rousse, Université de Lyon, Grande rue de la Croix Rousse, 69004 Lyon, France Tel: +33 4 72 07 25 10; fax: +33 4 72 07 19 85; e-mail: henri-jacques.clement@chu-lyon.fr

© 2010 European Society of Anaesthesiology