Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.

NCT01860521 NA COMPLETED Results posted

This study included women who underwent voluntary second trimester termination of pregnancy. Patients were randomized to programmed intermittent epidural anesthetic bolus or continuous epidural infusion for pain analgesia. In this randomized, double-blind study, the investigators assess the incidence of motor block (primary outcome), degree of satisfaction of the patients, total levobupivacaine and sufentanil consumption and adverse events (secondary outcomes) between the two study groups.

Details

Lead sponsor	IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Phase	NA
Status	COMPLETED
Enrolment	104
Start date	2011-09
Completion	2013-06

Conditions

• Medical; Abortion, Fetus

Interventions

• Programmed Intermittent Epidural Bolus
• Continuous Epidural Infusion
• Procedure of interruption of pregnancy
• Drug used for analgesia procedures
• Pump for programmed intermittent bolus.
• Pump for continuous epidural infusion.
• Drug used for termination of pregnancy procedure.

Primary outcomes

• Incidence of Motor Block — Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).
  The assessment of the degree of motor block was performed in the right and left lower extremities using the Breen modified Bromage score: 1 = complete block (unable to move feet or knees), 2 = almost complete block (able to move feet only), 3 = partial block (just able to move knees), 4 = detectable weakness of hip flexion while supine (between scores 3 and 5), 5 = no detectable weakness of hip flexion while supine (full flexion of knees), and 6 = able to stand and to perform partial knee bend. Patients with a Bromage score \< 6 were considered to have motor block.

Countries

Italy