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

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ClinicalTrials.gov Identifier: NCT01860521

Recruitment Status : Completed

First Posted : May 22, 2013

Results First Posted : October 28, 2013

Last Update Posted : October 28, 2013

Sponsor:

Information provided by (Responsible Party):

Umberto Leone Roberti Maggiore, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Medical; Abortion, Fetus	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.	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	104 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.
Study Start Date :	September 2011
Actual Primary Completion Date :	June 2013
Actual Study Completion Date :	June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Non-Drug Pain Management Pregnancy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Programmed Intermittent Epidural Bolus	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: 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). Other Names: Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA. Sufentanil: Fentatienil®, Angelini, Rome, Italy. Device: Pump for programmed intermittent bolus. Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used. Other Name: Pump: Gemstar®; Hospira, Lake Forest, USA. Drug: Drug used for termination of pregnancy procedure. Gemeprost pessaries. Other Name: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.
Active Comparator: Continuous Epidural Infusion	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). Other Names: Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA. Sufentanil: Fentatienil®, Angelini, Rome, Italy. Device: Pump for continuous epidural infusion. Pump administering continuous epidural infusion for the maintenance of analgesia was used. Other Name: Pump: Gemstar®; Hospira, Lake Forest, USA. Drug: Drug used for termination of pregnancy procedure. Gemeprost pessaries. Other Name: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.

Arm

Intervention/treatment

Active Comparator: Programmed Intermittent Epidural Bolus

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: 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).

Other Names:

Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA.
Sufentanil: Fentatienil®, Angelini, Rome, Italy.

Device: Pump for programmed intermittent bolus.

Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.

Other Name: Pump: Gemstar®; Hospira, Lake Forest, USA.

Drug: Drug used for termination of pregnancy procedure.

Gemeprost pessaries.

Other Name: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.

Active Comparator: Continuous Epidural Infusion

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

Drug: Drug used for analgesia procedures

Other Names:

Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA.
Sufentanil: Fentatienil®, Angelini, Rome, Italy.

Device: Pump for continuous epidural infusion.

Pump administering continuous epidural infusion for the maintenance of analgesia was used.

Other Name: Pump: Gemstar®; Hospira, Lake Forest, USA.

Drug: Drug used for termination of pregnancy procedure.

Gemeprost pessaries.

Other Name: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.

Outcome Measures

Primary 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.

Secondary Outcome Measures :

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). ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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)

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860521

Locations

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Italy
Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa
Genoa, Ligury, Italy, 16132

Sponsors and Collaborators

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

Investigators

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Study Director:	Simone Ferrero, PhD	University of Genoa
Principal Investigator:	Umberto Leone Roberti Maggiore, MD	University of Genoa

More Information

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Responsible Party:	Umberto Leone Roberti Maggiore, Principal Investigator, Research Fellow., IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
ClinicalTrials.gov Identifier:	NCT01860521
Other Study ID Numbers:	SCUL 4022
First Posted:	May 22, 2013 Key Record Dates
Results First Posted:	October 28, 2013
Last Update Posted:	October 28, 2013
Last Verified:	August 2013

Keywords provided by Umberto Leone Roberti Maggiore, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy:


Termination of pregnancy Second trimester Programmed intermittent epidural bolus	Continuous epidural infusion Epidural analgesia Legally Induced Abortion

Additional relevant MeSH terms:

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Sufentanil Levobupivacaine Gemeprost Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents	Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents

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