Medical; Abortion, Fetus
Conditions
Keywords
Termination of pregnancy, Second trimester, Programmed intermittent epidural bolus, Continuous epidural infusion, Epidural analgesia, Legally Induced Abortion
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.
Interventions
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.
PROCEDUREContinuous 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.
PROCEDUREProcedure 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.
DRUGDrug 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).
DEVICEPump for programmed intermittent bolus.
Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
DEVICEPump for continuous epidural infusion.
Pump administering continuous epidural infusion for the maintenance of analgesia was used.
DRUGDrug used for termination of pregnancy procedure.
Gemeprost pessaries.
Sponsors
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Motor Block | 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
| Measure | Time frame | Description |
|---|---|---|
| Degree of Satisfaction of the Patients With the Analgesia Procedure | 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 | 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). | — |
Countries
Italy
Participant flow
Recruitment details
September 2011 - June 2013. University Hospital.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. | 52 |
| Total | 104 |
Baseline characteristics
| Characteristic | Programmed Intermittent Epidural Bolus | Continuous Epidural Infusion | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants | 52 Participants | 104 Participants |
| Age Continuous | 32.4 years STANDARD_DEVIATION 5.3 | 33.3 years STANDARD_DEVIATION 4.7 | 32.8 years STANDARD_DEVIATION 5 |
| Region of Enrollment Italy | 52 participants | 52 participants | 104 participants |
| Sex: Female, Male Female | 52 Participants | 52 Participants | 104 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 52 | 21 / 52 |
| serious Total, serious adverse events | 3 / 52 | 3 / 52 |
Outcome results
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.
Time frame: Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Epidural Infusion | Incidence of Motor Block | 24 participants |
| Programmed Intermittent Epidural Bolus | Incidence of Motor Block | 3 participants |
p-value: <0.001Chi-squared
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.
Time frame: At discharge from the hospital (up to 72 hours from starting of the procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Epidural Infusion | Degree of Satisfaction of the Patients With the Analgesia Procedure | 73.2 mm | Standard Deviation 19.6 |
| Programmed Intermittent Epidural Bolus | Degree of Satisfaction of the Patients With the Analgesia Procedure | 84.4 mm | Standard Deviation 15.2 |
p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary
Total Levobupivacaine Consumption
Time frame: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Epidural Infusion | Total Levobupivacaine Consumption | 86.2 mg | Standard Deviation 27 |
| Programmed Intermittent Epidural Bolus | Total Levobupivacaine Consumption | 75.5 mg | Standard Deviation 26.8 |
p-value: 0.047Wilcoxon (Mann-Whitney)
Secondary
Total Sufentanil Consumption.
Time frame: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Continuous Epidural Infusion | Total Sufentanil Consumption. | 69.0 microg | Standard Deviation 21.6 |
| Programmed Intermittent Epidural Bolus | Total Sufentanil Consumption. | 60.4 microg | Standard Deviation 21.5 |
p-value: 0.047Wilcoxon (Mann-Whitney)