Trial Outcomes & Findings for Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia (NCT NCT02973048)
NCT ID: NCT02973048
Last Updated: 2020-07-02
Results Overview
Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
until complete regression of motor block (up to 4 hours)
Results posted on
2020-07-02
Participant Flow
All participants were recruited at CHU Saint-Pierre and Sainte-Anne Saint-Rémy hospitals (Brussels). Of 88 patients assessed for eligibility, only 40 were randomized to treatment (17 not meeting inclusion criteria and 31 declined to participate)
Participant milestones
| Measure |
Hyperbaric Bupivacaine
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Hyperbaric Bupivacaine
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Overall Study
Epidural catheter insertion failure
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hyperbaric Bupivacaine
n=20 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=20 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.5 years
n=20 Participants
|
32 years
n=20 Participants
|
36 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Weight
|
74.8 kg
STANDARD_DEVIATION 12.85 • n=20 Participants
|
76.2 kg
STANDARD_DEVIATION 13.4 • n=20 Participants
|
75.5 kg
STANDARD_DEVIATION 12.98 • n=40 Participants
|
|
Height
|
164 cm
n=20 Participants
|
164 cm
n=20 Participants
|
164 cm
n=40 Participants
|
|
BMI
|
26.37 kg/m^2
n=20 Participants
|
26.19 kg/m^2
n=20 Participants
|
26.26 kg/m^2
n=40 Participants
|
|
American Society of Anesthesiologists physical status (ASA) II
|
20 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
40 Participants
n=40 Participants
|
|
Gestational Age (GA)
|
39 weeks
n=20 Participants
|
39 weeks
n=20 Participants
|
39 weeks
n=40 Participants
|
|
Gestity
|
2 Pregnancies
n=20 Participants
|
2 Pregnancies
n=20 Participants
|
2 Pregnancies
n=40 Participants
|
|
Parity
|
1 Deliveries
n=20 Participants
|
1 Deliveries
n=20 Participants
|
1 Deliveries
n=40 Participants
|
|
Previous c-Section
|
13 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
19 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: until complete regression of motor block (up to 4 hours)Time to regression of motor block is the time between maximal blockade (score 1, as evaluated by the Modified Bromage scale), and no blockade (score 6). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia, then every 15 minutes until the end of surgery, and thereafter, every 30 minutes until complete regression of motor block
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time to Regression of Motor Block
|
180 minutes
Interval 142.5 to 239.5
|
130 minutes
Interval 120.0 to 166.0
|
SECONDARY outcome
Timeframe: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)Time between spinal injection and reached bilateral T4 sensory level.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time to Successful Anesthesia (Successful Sensory Block)
|
9.63 minutes
Standard Deviation 3.48
|
11.18 minutes
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: until complete release of sensory block (T12-S1) (average 4 hours)Level of Sensory block is assessed as loss of sensation to cold, and represents the dermatomal level under which anesthesia is effective. It is measured every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, thereafter, once 30 minutes until total regression of sensory block (T12-S1). A dermatome is the area of skin that is supplied by a single spinal nerve - Dermatome levels : C5-C8 for Cervical levels and T1-T4 for Thoracic levels. To perform cesarean section loss of cold sensation at a dermatome of at least T4 has to be obtained. The results are expressed as the number of patients reaching each dermatomal level from T4 and above (see below) as maximal sensory level, this is a usual outcome used to evaluate the quality of anesthesia.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome C8
|
2 Participants
|
1 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome T1
|
0 Participants
|
0 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome T2
|
4 Participants
|
2 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome T3
|
7 Participants
|
6 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome T4
|
3 Participants
|
6 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome C5
|
0 Participants
|
1 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome C6
|
3 Participants
|
1 Participants
|
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Sensory level dermatome C7
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: until complete release of sensory block (T12-S1) (average 4 hours)Evaluation at every 2 minutes after spinal anesthesia during 15 minutes, then every 5 minutes until the end of surgery, and thereafter, every 30 minutes until total regression of sensory block (T12-S1).
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time to Resolution of Sensory Block
|
212.95 minutes
Standard Deviation 51.48
|
169.59 minutes
Standard Deviation 32.71
|
SECONDARY outcome
Timeframe: From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)Time of installation of the motor block (time between spinal injection and maximum motor block of 1, as evaluated by the Modified Bromage scale). Degree of motor blockade is assessed before and 10, 15, 20 minutes after spinal anesthesia
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time to Motor Block Onset
|
16 minutes
Interval 10.0 to 16.0
|
10 minutes
Interval 10.0 to 16.0
|
SECONDARY outcome
Timeframe: up to 2 hours after surgeryArterial blood pressure will be measured at every 1 minute during the first 15 minutes, then at every 2.5 minutes until the end of surgery, and at every 20 minutes in the Post Anesthesia Care Unit (PACU). A low blood pressure (hypotension) is defined as a systolic blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia)
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Number of Patients With Hypotension and Use of Vasopressors
Hypotension
|
17 Participants
|
9 Participants
|
|
Number of Patients With Hypotension and Use of Vasopressors
Vasopressors use
|
16 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: up to 4 hours after surgeryAll parturients will be questioned and examined for urinary retention (yes or no)
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Number of Participants With Urinary Retention
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: up to 24h after surgeryTime for the patients to be able to walk in their room then in the hallway without any assistance for the first time.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time to First Walk
|
318 Minutes
Interval 194.0 to 420.0
|
198 Minutes
Interval 175.5 to 250.75
|
SECONDARY outcome
Timeframe: up to 24 hours after surgeryAll patients will be asked to rate their satisfaction about anesthetic technique during surgery and in the arrival in the Post Anesthesia Care Unit (PACU). Satisfaction evaluated by Visual analog scale (0 cm= very unsatisfied and 10cm = very satisfied)
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
|
9 score on a scale
Interval 8.0 to 9.0
|
9 score on a scale
Interval 8.0 to 9.25
|
SECONDARY outcome
Timeframe: up to 72 hours after surgeryMaternal rehabilitation is evaluated at postoperative Day1, postoperative Day 2 and postoperative Day 3. Evaluation by Visual analog scale (0 cm= very poor and 10cm = excellent)
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
|
9 score on a scale
Interval 7.0 to 10.0
|
9 score on a scale
Interval 8.0 to 9.25
|
SECONDARY outcome
Timeframe: up to 72 hours after surgeryEvaluation from 15 minutes after spinal injection to the end of surgery, then every 4 hours for 24 hours, then once a day for 3 days (score 0=no symptom; 1=symptom with no necessary treatment; 2=symptom present and treated)
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Peroperative · score 0 (no symptom)
|
18 Participants
|
13 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Peroperative · score 1 (symptom with no necessary treatment)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Peroperative · score 2 (symptom present and treated)
|
0 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 0 · score 0 (no symptom)
|
14 Participants
|
12 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 0 · score 1 (symptom with no necessary treatment)
|
4 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 0 · score 2 (symptom present and treated)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 1 · score 0 (no symptom)
|
16 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 1 · score 1 (symptom with no necessary treatment)
|
3 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 1 · score 2 (symptom present and treated)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 2 · score 0 (no symptom)
|
18 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 2 · score 1 (symptom with no necessary treatment)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 2 · score 2 (symptom present and treated)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 3 · score 0 (no symptom)
|
18 Participants
|
17 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 3 · score 1 (symptom with no necessary treatment)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Day 3 · score 2 (symptom present and treated)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 15 Days after surgeryEvaluation of apparition of TNS at postoperative Day 1, postoperative Day 2, postoperative Day 3 and postoperative Day 15. TNS are defined as pain and/or dysesthesia occurred after complete release of sensory block at the gluteal level, at the thighs and at the legs.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Number of Participants With Transient Neurologic Symptoms (TNS)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 24 hours after surgeryPopulation: VAS are presented only at 1 Hour, 2 Hours , 3 Hours and 4 Hours post-surgery
Pain levels will be determined at incision, baby delivery, peritoneal and skin closure, every 5 minutes during surgery, and thereafter every 4 hours for 24 hours. Visual analog pain score (scale = 0 no pain; 10 = worst pain imaginable). Patient will receive additional analgesic treatment above VAS\>3.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Pain as Assessed by Visual Analogue Scale
VAS at 1 Hour · VAS=0 (no pain)
|
13 Participants
|
7 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 1 Hour · VAS 1-2 (No additional analgesic treatment)
|
6 Participants
|
9 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 1 Hour · VAS >3 (additional analgesic treatment)
|
0 Participants
|
1 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 2 Hours · VAS=0 (no pain)
|
11 Participants
|
3 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 2 Hours · VAS 1-2 (No additional analgesic treatment)
|
6 Participants
|
13 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 2 Hours · VAS >3 (additional analgesic treatment)
|
2 Participants
|
1 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 3 Hours · VAS=0 (no pain)
|
9 Participants
|
9 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 3 Hours · VAS 1-2 (No additional analgesic treatment)
|
7 Participants
|
6 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 3 Hours · VAS >3 (additional analgesic treatment)
|
3 Participants
|
2 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 4 Hours · VAS=0 (no pain)
|
10 Participants
|
12 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 4 Hours · VAS 1-2 (No additional analgesic treatment)
|
7 Participants
|
5 Participants
|
|
Pain as Assessed by Visual Analogue Scale
VAS at 4 Hours · VAS >3 (additional analgesic treatment)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: up to 10 minutes after baby extractionNewborn Apgar score assessed at 1, 5, 10 minutes after baby extraction. The Apgar score is determined by evaluating the newborn baby on five simple criteria on a scale from 0 to 2, then summing up the five values thus obtained. The overall resulting score ranges from 0 to 10 ( 0-3 : severely depressed, 4-6 : Moderately depressed and 7-10 : Excellent condition). The five criteria are summarized using words chosen to form an abbreviation (Appearance, Pulse, Grimace, Activity, Respiration).
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Newborn Apgar Score
Apgar at 1 minute
|
9 score on a scale
Interval 9.0 to 9.0
|
9 score on a scale
Interval 9.0 to 9.0
|
|
Newborn Apgar Score
Apgar at 3 minutes
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 10.0 to 10.0
|
|
Newborn Apgar Score
Apgar at 5 minutes
|
10 score on a scale
Interval 10.0 to 10.0
|
10 score on a scale
Interval 10.0 to 10.0
|
SECONDARY outcome
Timeframe: average 1 hourNewborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control in obstetrics, and expressed as a percentage of total hemoglobinemia. Methemoglobinemia (MetHb) is a blood disorder in which an abnormal amount of methemoglobin (hemoglobin in the form metalloprotein) is produced. This specific type of of Hemoglobin carries oxygen through your blood but doesn't release it to the cells.
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Newborn Methemoglobinemia (MetHb)
|
1.8 percentage of MetHb
Interval 1.7 to 1.9
|
1.7 percentage of MetHb
Interval 1.6 to 1.9
|
SECONDARY outcome
Timeframe: average 1 hourNewborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Newborn Umbilical pH
|
7.33 pH
Interval 7.29 to 7.34
|
7.32 pH
Interval 7.29 to 7.33
|
SECONDARY outcome
Timeframe: average 1 hourTime between incision and end of surgery
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time of Surgery
|
45 minutes
Interval 40.5 to 56.5
|
50 minutes
Interval 44.0 to 54.0
|
SECONDARY outcome
Timeframe: average 1 hourTime between spinal injection and baby delivery
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time From Spinal Injection to Baby Delivery
|
24 minutes
Interval 22.0 to 27.0
|
25 minutes
Interval 24.0 to 27.0
|
SECONDARY outcome
Timeframe: average 1 hourTime between baby delivery, and the end of surgery
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Time From Baby Delivery to End of Surgery
|
36.68 minutes
Standard Deviation 10.19
|
38.24 minutes
Standard Deviation 6.55
|
SECONDARY outcome
Timeframe: average 1 hourTotal blood loss (milliliters) during surgery
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Total Blood Loss
|
415 milliliters
Interval 312.5 to 746.25
|
485 milliliters
Interval 305.0 to 562.5
|
SECONDARY outcome
Timeframe: average 1 hourSatisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Obstetrician Satisfaction
|
4 score on a scale
Interval 4.0 to 4.0
|
4 score on a scale
Interval 4.0 to 4.0
|
SECONDARY outcome
Timeframe: 72 hours after surgerySatisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
Outcome measures
| Measure |
Hyperbaric Bupivacaine
n=19 Participants
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 Participants
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Midwife Satisfaction
|
3 score on a scale
Interval 1.5 to 4.0
|
4 score on a scale
Interval 3.0 to 4.0
|
Adverse Events
Hyperbaric Bupivacaine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Hyperbaric Prilocaine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Hyperbaric Bupivacaine
n=19 participants at risk
Hyperbaric bupivacaine 0.5% will be administered at the dose of 10 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric bupivacaine: The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
Hyperbaric Prilocaine
n=17 participants at risk
Hyperbaric prilocaine 2% will be administered at the dose of 50 mg intrathecally associated with 100 µg of morphine and 2.5 µg of sufentanyl.
Hyperbaric prilocaine: The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
|
|---|---|---|
|
Nervous system disorders
Transient neurologic symptoms
|
5.3%
1/19 • Adverse event were collected from spinal injection until 15 Days following the day of surgery.
|
5.9%
1/17 • Adverse event were collected from spinal injection until 15 Days following the day of surgery.
|
|
Gastrointestinal disorders
Nausea
|
42.1%
8/19 • Adverse event were collected from spinal injection until 15 Days following the day of surgery.
|
41.2%
7/17 • Adverse event were collected from spinal injection until 15 Days following the day of surgery.
|
Additional Information
Panayota Kapessidou
Centre Hospitalier Universitaire Saint Pierre
Phone: +32.2.535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place