Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia

Not Applicable

Completed

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

Lead Sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

contraindication to epidural analgesia and to narcotics
history of drug abuse or chronic use
maternal disease (such as severe asthma, cardiac, liver or kidney disease)
inability to comprehend or comply with the analgesia pain management procedures.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Degree of Satisfaction of the Patients With the Analgesia Procedure	At discharge from the hospital (up to 72 hours from starting of the procedure).	At discharge from the hospital, patients were requested to answer the following question "Taking into consideration the variations in pain symptoms, as well as the adverse events experienced, if any, how would you define the grade of satisfaction with your analgesic treatment?" The grade of satisfaction was assessed using a visual analog scale (VAS) where 0 corresponded to "completely unsatisfied" and 100 to "completely satisfied".
Total Levobupivacaine Consumption	At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
Total Sufentanil Consumption.	During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).

Locations (1): Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa
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Genoa, Ligury, Italy