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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Programmed Intermittent Epidural Bolus | Active Comparator |
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| Continuous Epidural Infusion | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Programmed Intermittent Epidural Bolus | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Ferrero, PhD | Universita degli Studi di Genova | Study Director |
| Umberto Leone Roberti Maggiore, MD | Universita degli Studi di Genova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, San Martino Hospital and National Institute for Cancer Research, University of Genoa | Genoa | Ligury | 16132 | Italy |
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September 2011 - June 2013. University Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continuous Epidural Infusion | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Continuous Epidural Infusion | Procedure | 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. |
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| Procedure of interruption of pregnancy | Procedure | 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. |
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| Drug used for analgesia procedures | Drug | 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). |
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| Pump for programmed intermittent bolus. | Device | Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used. |
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| Pump for continuous epidural infusion. | Device | Pump administering continuous epidural infusion for the maintenance of analgesia was used. |
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| Drug used for termination of pregnancy procedure. | Drug | Gemeprost pessaries. |
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| 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). |
| FG001 | Programmed Intermittent Epidural Bolus | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Continuous Epidural Infusion | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. |
| BG001 | Programmed Intermittent Epidural Bolus | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure). |
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| Secondary | 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". | Posted | Mean | Standard Deviation | mm | At discharge from the hospital (up to 72 hours from starting of the procedure). |
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| Secondary | Total Levobupivacaine Consumption | Posted | Mean | Standard Deviation | mg | At the moment of fetal expulsion (up to 66 hours from starting of the procedure). |
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| Secondary | Total Sufentanil Consumption. | Posted | Mean | Standard Deviation | microg | During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Continuous Epidural Infusion | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. | 3 | 52 | 33 | 52 | ||
| EG001 | Programmed Intermittent Epidural Bolus | Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used. 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. | 3 | 52 | 21 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Uterine perforation | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Hypotension | General disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Pruritus | General disorders | Systematic Assessment |
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| Shivering | General disorders | Systematic Assessment |
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| Sedation | General disorders | Systematic Assessment |
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| Respiratory depression | General disorders | Systematic Assessment |
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| Failure of induction | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
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| Dr. Umberto Leone Roberti Maggiore | IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy | 00393289461340 | ulrm@libero.it |
| >=65 years |
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| Male |
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