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.
Full Title of Study: “Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: June 2013
- Procedure: Programmed Intermittent Epidural Bolus
- An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.
- Procedure: Continuous Epidural Infusion
- An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.
- Procedure: Procedure of interruption of pregnancy
- Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.
- Drug: Drug used for analgesia procedures
- Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).
- Device: Pump for programmed intermittent bolus.
- Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
- Device: Pump for continuous epidural infusion.
- Pump administering continuous epidural infusion for the maintenance of analgesia was used.
- Drug: Drug used for termination of pregnancy procedure.
- Gemeprost pessaries.
Arms, Groups and Cohorts
- Active Comparator: Programmed Intermittent Epidural Bolus
- Active Comparator: Continuous Epidural Infusion
Clinical Trial Outcome Measures
- Incidence of Motor Block
- Time Frame: 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.
- Degree of Satisfaction of the Patients With the Analgesia Procedure
- Time Frame: 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
- Time Frame: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
- Total Sufentanil Consumption.
- Time Frame: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).
Participating in This Clinical Trial
- age ≥ 18 years
- pregnancy at second trimester
- willingness of voluntary interrupt the pregnancy
- comprehension of Italian Language
- baseline pain score ≥ 30 on a 100-mm visual analog pain scale (VAPS)
- 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.
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Provider of Information About this Clinical Study
- Principal Investigator: Umberto Leone Roberti Maggiore, Principal Investigator, Research Fellow. – IRCCS Azienda Ospedaliera Universitaria San Martino – IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Overall Official(s)
- Simone Ferrero, PhD, Study Director, University of Genoa
- Umberto Leone Roberti Maggiore, MD, Principal Investigator, University of Genoa
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