Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
NCT ID: NCT01860521
Last Updated: 2013-10-28
Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2011-09-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Programmed Intermittent Epidural Bolus
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 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 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).
Pump for programmed intermittent bolus.
Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
Drug used for termination of pregnancy procedure.
Gemeprost pessaries.
Continuous Epidural Infusion
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 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 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).
Pump for continuous epidural infusion.
Pump administering continuous epidural infusion for the maintenance of analgesia was used.
Drug used for termination of pregnancy procedure.
Gemeprost pessaries.
Interventions
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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.
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 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 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).
Pump for programmed intermittent bolus.
Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
Pump for continuous epidural infusion.
Pump administering continuous epidural infusion for the maintenance of analgesia was used.
Drug used for termination of pregnancy procedure.
Gemeprost pessaries.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
OTHER
Responsible Party
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Umberto Leone Roberti Maggiore
Principal Investigator, Research Fellow.
Principal Investigators
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Simone Ferrero, PhD
Role: STUDY_DIRECTOR
Universita degli Studi di Genova
Umberto Leone Roberti Maggiore, MD
Role: PRINCIPAL_INVESTIGATOR
Universita degli Studi di Genova
Locations
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Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa
Genoa, Ligury, Italy
Countries
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Other Identifiers
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SCUL 4022
Identifier Type: -
Identifier Source: org_study_id