Trial Outcomes & Findings for Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia (NCT NCT01860521)
NCT ID: NCT01860521
Last Updated: 2013-10-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Assessed every hour from starting the analgesia procedure (up to 66 hours from starting of the procedure).
Results posted on
2013-10-28
Participant Flow
September 2011 - June 2013. University Hospital.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Termination of Pregnancy Analgesia
Baseline characteristics by cohort
| Measure |
Continuous Epidural Infusion
n=52 Participants
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.
|
Programmed Intermittent Epidural Bolus
n=52 Participants
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.
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
33.3 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
52 participants
n=5 Participants
|
52 participants
n=7 Participants
|
104 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Continuous Epidural Infusion
n=52 Participants
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.
|
Programmed Intermittent Epidural Bolus
n=52 Participants
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.
|
|---|---|---|
|
Incidence of Motor Block
|
24 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 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".
Outcome measures
| Measure |
Continuous Epidural Infusion
n=52 Participants
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.
|
Programmed Intermittent Epidural Bolus
n=52 Participants
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.
|
|---|---|---|
|
Degree of Satisfaction of the Patients With the Analgesia Procedure
|
73.2 mm
Standard Deviation 19.6
|
84.4 mm
Standard Deviation 15.2
|
SECONDARY outcome
Timeframe: At the moment of fetal expulsion (up to 66 hours from starting of the procedure).Outcome measures
| Measure |
Continuous Epidural Infusion
n=52 Participants
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.
|
Programmed Intermittent Epidural Bolus
n=52 Participants
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.
|
|---|---|---|
|
Total Levobupivacaine Consumption
|
86.2 mg
Standard Deviation 27.0
|
75.5 mg
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: During the whole analgesia procedure (assessed between the starting of the procedure until 66 hours).Outcome measures
| Measure |
Continuous Epidural Infusion
n=52 Participants
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.
|
Programmed Intermittent Epidural Bolus
n=52 Participants
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.
|
|---|---|---|
|
Total Sufentanil Consumption.
|
69.0 microg
Standard Deviation 21.6
|
60.4 microg
Standard Deviation 21.5
|
Adverse Events
Continuous Epidural Infusion
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Programmed Intermittent Epidural Bolus
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Continuous Epidural Infusion
n=52 participants at risk
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.
|
Programmed Intermittent Epidural Bolus
n=52 participants at risk
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.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Hemorrhage
|
1.9%
1/52
|
5.8%
3/52
|
|
Pregnancy, puerperium and perinatal conditions
Uterine perforation
|
5.7%
2/35
|
0.00%
0/37
|
Other adverse events
| Measure |
Continuous Epidural Infusion
n=52 participants at risk
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.
|
Programmed Intermittent Epidural Bolus
n=52 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
34.6%
18/52
|
13.5%
7/52
|
|
General disorders
Hypotension
|
3.8%
2/52
|
7.7%
4/52
|
|
Gastrointestinal disorders
Vomiting
|
5.8%
3/52
|
1.9%
1/52
|
|
General disorders
Pruritus
|
26.9%
14/52
|
32.7%
17/52
|
|
General disorders
Shivering
|
21.2%
11/52
|
17.3%
9/52
|
|
General disorders
Sedation
|
5.8%
3/52
|
0.00%
0/52
|
|
General disorders
Respiratory depression
|
3.8%
2/52
|
0.00%
0/52
|
|
Pregnancy, puerperium and perinatal conditions
Failure of induction
|
1.9%
1/52
|
1.9%
1/52
|
Additional Information
Dr. Umberto Leone Roberti Maggiore
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Phone: 00393289461340
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place