Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
1 other identifier
interventional
104
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2013
CompletedFirst Posted
Study publicly available on registry
May 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedResults Posted
Study results publicly available
October 28, 2013
CompletedOctober 28, 2013
August 1, 2013
1.8 years
May 13, 2013
June 10, 2013
August 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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 (up to 72 hours from starting of the procedure).
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).
Study Arms (2)
Programmed Intermittent Epidural Bolus
ACTIVE COMPARATORContinuous Epidural Infusion
ACTIVE COMPARATORInterventions
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.
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.
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.
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 administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
Pump administering continuous epidural infusion for the maintenance of analgesia was used.
Gemeprost pessaries.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa
Genoa, Ligury, 16132, Italy
Results Point of Contact
- Title
- Dr. Umberto Leone Roberti Maggiore
- Organization
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study Officials
- STUDY DIRECTOR
Simone Ferrero, PhD
Universita degli Studi di Genova
- PRINCIPAL INVESTIGATOR
Umberto Leone Roberti Maggiore, MD
Universita degli Studi di Genova
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Research Fellow.
Study Record Dates
First Submitted
May 13, 2013
First Posted
May 22, 2013
Study Start
September 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 28, 2013
Results First Posted
October 28, 2013
Record last verified: 2013-08