Medical; Abortion, FetusNCT01860521

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

A study testing Programmed Intermittent Epidural Bolus, Continuous Epidural Infusion and Procedure of interruption of pregnancy in people with Medical; Abortion, Fetus, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Medical; Abortion, Fetus
What is being tested?: Programmed Intermittent Epidural Bolus, Continuous Epidural Infusion and Procedure of interruption of pregnancy
Type of treatment: Injection or infusion, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: 1 siteItaly
Study dates: Sep 2011to Jun 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

Other trials in Italy

About this study

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

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.

Conditions: Medical; Abortion, Fetus
Being tested: Programmed Intermittent Epidural Bolus, Continuous Epidural Infusion, Procedure of interruption of pregnancy, Drug used for analgesia procedures, Pump for programmed intermittent bolus.
Keywords: Termination of pregnancy, Second trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally Induced Abortion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Programmed Intermittent Epidural BolusProcedure or surgery
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 InfusionProcedure or surgery
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 pregnancyProcedure or surgery
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 proceduresDrug
Also called Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA., Sufentanil: Fentatienil®, Angelini, Rome, Italy.
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.Device
Also called Pump: Gemstar®; Hospira, Lake Forest, USA.
Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
Pump for continuous epidural infusion.Device
Also called Pump: Gemstar®; Hospira, Lake Forest, USA.
Pump administering continuous epidural infusion for the maintenance of analgesia was used.
Drug used for termination of pregnancy procedure.Drug
Also called Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.
Gemeprost pessaries.

Study groups in NCT01860521
Study group	Role	What they receive
Programmed Intermittent Epidural Bolus	Active comparator	Not described Receives: Procedure: Programmed Intermittent Epidural Bolus; Procedure: Procedure of interruption of pregnancy; Drug: Drug used for analgesia procedures; Device: Pump for programmed intermittent bolus.; Drug: Drug used for termination of pregnancy procedure.
Continuous Epidural Infusion	Active comparator	Not described Receives: Procedure: Continuous Epidural Infusion; Procedure: Procedure of interruption of pregnancy; Drug: Drug used for analgesia procedures; Device: Pump for continuous epidural infusion.; Drug: Drug used for termination of pregnancy procedure.

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Motor Block
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.
Measured: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).

Secondary outcomes (3)

Degree of Satisfaction of the Patients With the Analgesia 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".
Measured: At discharge from the hospital (up to 72 hours from starting of the procedure).
Total Levobupivacaine Consumption
Measured: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
Total Sufentanil Consumption.
Measured: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Jun 2013

First posted22 May 2013 (estimated)
Study startSep 2011
Primary completionJun 2013
Study completionJun 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Medical; Abortion, FetusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01860521
Sponsor's protocol ID: SCUL 4022
Status last verified: Aug 2013
First submitted: 13 May 2013
Last updated: 28 Oct 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Second Trimester Voluntary Termination of Pregnancy Analgesia: a Randomized Study.
ClinicalTrials.gov ID: NCT01860521
Acronym / sponsor ID: SCUL 4022
Conditions: Medical; Abortion, Fetus
Keywords: Termination of pregnancy, Second trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally Induced Abortion
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
Study start: Sep 2011
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 22 May 2013 (estimated)
Results: Posted 28 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Programmed Intermittent Epidural Bolus	Active comparator	Procedure: Programmed Intermittent Epidural Bolus, Procedure: Procedure of interruption of pregnancy, Drug: Drug used for analgesia procedures, Device: Pump for programmed intermittent bolus., Drug: Drug used for termination of pregnancy procedure.
Continuous Epidural Infusion	Active comparator	Procedure: Continuous Epidural Infusion, Procedure: Procedure of interruption of pregnancy, Drug: Drug used for analgesia procedures, Device: Pump for continuous epidural infusion., Drug: Drug used for termination of pregnancy procedure.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Programmed Intermittent Epidural BolusAn 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 or surgery	Programmed Intermittent Epidural Bolus
Continuous Epidural InfusionAn 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 or surgery	Continuous Epidural Infusion
Procedure of interruption of pregnancyPatients 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.	Procedure or surgery	Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus
Drug used for analgesia proceduresAlso: Levobupivacaine: Chirocaine®, Abbott, Chicago, IL, USA., Sufentanil: Fentatienil®, Angelini, Rome, Italy.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).	Drug	Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus
Pump for programmed intermittent bolus.Also: Pump: Gemstar®; Hospira, Lake Forest, USA.Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.	Device	Programmed Intermittent Epidural Bolus
Pump for continuous epidural infusion.Also: Pump: Gemstar®; Hospira, Lake Forest, USA.Pump administering continuous epidural infusion for the maintenance of analgesia was used.	Device	Continuous Epidural Infusion
Drug used for termination of pregnancy procedure.Also: Gemeprost pessaries: Cervidil®, Merck Serono SPA, Rome, Italy.Gemeprost pessaries.	Drug	Continuous Epidural Infusion, Programmed Intermittent Epidural Bolus

Primary outcome

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.

3 secondary outcomes

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).
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).

Results and safety

Results posted to the registry on 28 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Epidural Infusion	52	52
Programmed Intermittent Epidural Bolus	52	52

Primary outcome: Incidence of Motor Block

Time frame: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).. Number. Unit: participants

Measure	Continuous Epidural Infusion n = 52	Programmed Intermittent Epidural Bolus n = 52
Value	24	3

Continuous Epidural Infusion vs Programmed Intermittent Epidural Bolus: p < 0.001, Chi-squared

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1.9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Epidural Infusion	3 of 52 (5.8%)	33 of 52 (63.5%)	Not reported
Programmed Intermittent Epidural Bolus	3 of 52 (5.8%)	21 of 52 (40.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Simone Ferrero, PhD study director

Universita degli Studi di Genova

Umberto Leone Roberti Maggiore, MD principal investigator

Universita degli Studi di Genova

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Motor Block (time frame: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01860521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2013.