Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia

• Sponsor: Centre Hospitalier Universitaire Saint Pierre (Other)
• Overall Status: Completed
• CT.gov ID: NCT02973048
• Collaborator: (none)
• Enrollment: 40
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7.9
• Patients Per Site: 20
• Patients Per Site Per Month: 2.5

Study Details

Study Description

Brief Summary

Over the past 15 years, cesarean delivery is most commonly performed under spinal anesthesia using hyperbaric bupivacaine which provides an adequate sensory and motor block. Despite effective surgical anesthesia, bupivacaine is associated with long duration motor block and dose-dependent maternal hypotension potentially harmful for the fetus. Prilocaine with its new 2% hyperbaric formulation (HP), developed recently, showed rapid onset of action and faster regression of motor block compared to other local anesthetics without noteworthy side-effects when used intrathecally. The aim of this randomized, multicenter, powered clinical trial is to investigate whether HP may be an efficient alternative to hyperbaric bupivacaine for scheduled caesarean delivery under spinal anesthesia, with more rapid rehabilitation and less adverse effects. Our hypothesis is that hyperbaric prilocaine offers shorter motor block and more rapid rehabilitation than bupivacaine.

Condition or Disease	Intervention/Treatment	Phase
Pregnant Women; Pain; Hypotension	Drug: Hyperbaric bupivacaine; Drug: Hyperbaric prilocaine	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
• Actual Study Start Date: Mar 12, 2018
• Actual Primary Completion Date: Nov 8, 2018
• Actual Study Completion Date: Nov 8, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: 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.; Other Names: Marcaine
Active Comparator: 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.	Drug: 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.; Other Names: Tachipri

Outcome Measures

Primary Outcome Measures

1. Time to Regression of Motor Block [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

Secondary Outcome Measures

1. Time to Successful Anesthesia (Successful Sensory Block) [From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)]

   Time between spinal injection and reached bilateral T4 sensory level.

2. Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia [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.

3. Time to Resolution of Sensory Block [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).

4. Time to Motor Block Onset [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

5. Number of Patients With Hypotension and Use of Vasopressors [up to 2 hours after surgery]

   Arterial 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)

6. Number of Participants With Urinary Retention [up to 4 hours after surgery]

   All parturients will be questioned and examined for urinary retention (yes or no)

7. Time to First Walk [up to 24h after surgery]

   Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.

8. Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) [up to 24 hours after surgery]

   All 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)

9. Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) [up to 72 hours after surgery]

   Maternal 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)

10. Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) [up to 72 hours after surgery]

    Evaluation 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)

11. Number of Participants With Transient Neurologic Symptoms (TNS) [up to 15 Days after surgery]

    Evaluation 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.

12. Pain as Assessed by Visual Analogue Scale [up to 24 hours after 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.

13. Newborn Apgar Score [up to 10 minutes after baby extraction]

    Newborn 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).

14. Newborn Methemoglobinemia (MetHb) [average 1 hour]

    Newborn 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.

15. Newborn Umbilical pH [average 1 hour]

    Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value

16. Time of Surgery [average 1 hour]

    Time between incision and end of surgery

17. Time From Spinal Injection to Baby Delivery [average 1 hour]

    Time between spinal injection and baby delivery

18. Time From Baby Delivery to End of Surgery [average 1 hour]

    Time between baby delivery, and the end of surgery

19. Total Blood Loss [average 1 hour]

    Total blood loss (milliliters) during surgery

20. Obstetrician Satisfaction [average 1 hour]

    Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery

21. Midwife Satisfaction [72 hours after surgery]

    Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria :

• American Society of Anesthesiologists physical status (ASA) < III

• Age 18-40 year

• Body Weight <110 kg

• Height between 160 and 175 cm

• Gestational age>37 SA

• Elective cesarean delivery

• Singleton pregnancy

• Non complicated pregnancy

• Signed informed consent obtained prior to any study specific assessments and procedures

Exclusion Criteria:

• Twin pregnancy

• History of 2 cesarean section or more

• Diabetes and gestational diabetes

• Placenta praevia

• Congenital foetal abnormality

• Intrauterine growth retardation

• Patient in labour

• Membrane rupture

• Known allergy to local anaesthetics

• Standard contraindications to neuraxial block.

• Disagreement of the patient

• Neurological impairment

• Gestational low blood pressure

• Pre eclampsia and eclampsia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)	Brussels	Brussels Capital	Belgium	1000
2	Clinique Ste-Anne/St-Remi	Anderlecht		Belgium	1070

Sponsors and Collaborators

• Centre Hospitalier Universitaire Saint Pierre

Investigators

• Study Director: Panayota KAPESSIDOU, MD, PhD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
• Principal Investigator: Philippe GOFFARD, MD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 2, 2017

More Information

Publications

• Gautier P, De Kock M, Huberty L, Demir T, Izydorczic M, Vanderick B. Comparison of the effects of intrathecal ropivacaine, levobupivacaine, and bupivacaine for Caesarean section. Br J Anaesth. 2003 Nov;91(5):684-9.
• Guntz E, Kapessidou Y. Spinal prilocaine for same-day surgery: the importance of equipotent doses. Can J Anaesth. 2016 Aug;63(8):985-6. doi: 10.1007/s12630-016-0645-7. Epub 2016 Apr 4.
• Guntz E, Latrech B, Tsiberidis C, Gouwy J, Kapessidou Y. ED50 and ED90 of intrathecal hyperbaric 2% prilocaine in ambulatory knee arthroscopy. Can J Anaesth. 2014 Sep;61(9):801-7. doi: 10.1007/s12630-014-0189-7. Epub 2014 Jun 7.

• Responsible Party: Centre Hospitalier Universitaire Saint Pierre
• ClinicalTrials.gov Identifier: NCT02973048
• Other Study ID Numbers: B076201627677
• First Posted: Nov 25, 2016
• Last Update Posted: Jul 2, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire Saint Pierre: Cesarean delivery; Spinal anesthesia; Local anesthetics
• Additional relevant MeSH terms: Hypotension; Bupivacaine; Prilocaine

Study Results

Participant Flow

Recruitment Details	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)

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Period Title: Overall Study
STARTED	20	20
COMPLETED	19	17
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	20	20	40
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	36.5	32	36
Sex: Female, Male (Count of Participants)
Female	20 100%	20 100%	40 100%
Male	0 0%	0 0%	0 0%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	74.8 (12.85)	76.2 (13.4)	75.5 (12.98)
Height (cm) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [cm]	164	164	164
BMI (kg/m^2) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [kg/m^2]	26.37	26.19	26.26
American Society of Anesthesiologists physical status (ASA) II (Count of Participants)
Count of Participants [Participants]	20 100%	20 100%	40 100%
Gestational Age (GA) (weeks) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [weeks]	39	39	39
Gestity (Pregnancies) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Pregnancies]	2	2	2
Parity (Deliveries) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [Deliveries]	1	1	1
Previous c-Section (Number) [Number]
Number [Participants]	13 65%	6 30%	19 47.5%

Outcome Measures

1. Primary Outcome

Title	Time to Regression of Motor Block
Description	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
Time Frame	until complete regression of motor block (up to 4 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [minutes]	180	130

2. Secondary Outcome

Title	Time to Successful Anesthesia (Successful Sensory Block)
Description	Time between spinal injection and reached bilateral T4 sensory level.
Time Frame	From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Mean (Standard Deviation) [minutes]	9.63 (3.48)	11.18 (2.7)

3. Secondary Outcome

Title	Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Description	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.
Time Frame	until complete release of sensory block (T12-S1) (average 4 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Sensory level dermatome C5	0 0%	1 5%
Sensory level dermatome C6	3 15%	1 5%
Sensory level dermatome C7	0 0%	0 0%
Sensory level dermatome C8	2 10%	1 5%
Sensory level dermatome T1	0 0%	0 0%
Sensory level dermatome T2	4 20%	2 10%
Sensory level dermatome T3	7 35%	6 30%
Sensory level dermatome T4	3 15%	6 30%

4. Secondary Outcome

Title	Time to Resolution of Sensory Block
Description	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).
Time Frame	until complete release of sensory block (T12-S1) (average 4 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Mean (Standard Deviation) [minutes]	212.95 (51.48)	169.59 (32.71)

5. Secondary Outcome

Title	Time to Motor Block Onset
Description	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
Time Frame	From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [minutes]	16	10

6. Secondary Outcome

Title	Number of Patients With Hypotension and Use of Vasopressors
Description	Arterial 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)
Time Frame	up to 2 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Hypotension	17 85%	9 45%
Vasopressors use	16 80%	10 50%

7. Secondary Outcome

Title	Number of Participants With Urinary Retention
Description	All parturients will be questioned and examined for urinary retention (yes or no)
Time Frame	up to 4 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Count of Participants [Participants]	2 10%	2 10%

8. Secondary Outcome

Title	Time to First Walk
Description	Time for the patients to be able to walk in their room then in the hallway without any assistance for the first time.
Time Frame	up to 24h after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [Minutes]	318	198

9. Secondary Outcome

Title	Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
Description	All 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)
Time Frame	up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [score on a scale]	9	9

10. Secondary Outcome

Title	Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
Description	Maternal 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)
Time Frame	up to 72 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [score on a scale]	9	9

11. Secondary Outcome

Title	Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Description	Evaluation 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)
Time Frame	up to 72 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
score 0 (no symptom)	18 90%	13 65%
score 1 (symptom with no necessary treatment)	1 5%	1 5%
score 2 (symptom present and treated)	0 0%	3 15%
score 0 (no symptom)	14 70%	12 60%
score 1 (symptom with no necessary treatment)	4 20%	5 25%
score 2 (symptom present and treated)	1 5%	0 0%
score 0 (no symptom)	16 80%	17 85%
score 1 (symptom with no necessary treatment)	3 15%	0 0%
score 2 (symptom present and treated)	0 0%	0 0%
score 0 (no symptom)	18 90%	17 85%
score 1 (symptom with no necessary treatment)	1 5%	0 0%
score 2 (symptom present and treated)	0 0%	0 0%
score 0 (no symptom)	18 90%	17 85%
score 1 (symptom with no necessary treatment)	1 5%	0 0%
score 2 (symptom present and treated)	0 0%	0 0%

12. Secondary Outcome

Title	Number of Participants With Transient Neurologic Symptoms (TNS)
Description	Evaluation 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.
Time Frame	up to 15 Days after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Count of Participants [Participants]	0 0%	0 0%

13. Secondary Outcome

Title	Pain as Assessed by Visual Analogue Scale
Description	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.
Time Frame	up to 24 hours after surgery

Outcome Measure Data

Analysis Population Description

VAS are presented only at 1 Hour, 2 Hours , 3 Hours and 4 Hours post-surgery

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
VAS=0 (no pain)	13 65%	7 35%
VAS 1-2 (No additional analgesic treatment)	6 30%	9 45%
VAS >3 (additional analgesic treatment)	0 0%	1 5%
VAS=0 (no pain)	11 55%	3 15%
VAS 1-2 (No additional analgesic treatment)	6 30%	13 65%
VAS >3 (additional analgesic treatment)	2 10%	1 5%
VAS=0 (no pain)	9 45%	9 45%
VAS 1-2 (No additional analgesic treatment)	7 35%	6 30%
VAS >3 (additional analgesic treatment)	3 15%	2 10%
VAS=0 (no pain)	10 50%	12 60%
VAS 1-2 (No additional analgesic treatment)	7 35%	5 25%
VAS >3 (additional analgesic treatment)	2 10%	0 0%

14. Secondary Outcome

Title	Newborn Apgar Score
Description	Newborn 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).
Time Frame	up to 10 minutes after baby extraction

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Apgar at 1 minute	9	9
Apgar at 3 minutes	10	10
Apgar at 5 minutes	10	10

15. Secondary Outcome

Title	Newborn Methemoglobinemia (MetHb)
Description	Newborn 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.
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [percentage of MetHb]	1.8	1.7

16. Secondary Outcome

Title	Newborn Umbilical pH
Description	Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [pH]	7.33	7.32

17. Secondary Outcome

Title	Time of Surgery
Description	Time between incision and end of surgery
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [minutes]	45	50

18. Secondary Outcome

Title	Time From Spinal Injection to Baby Delivery
Description	Time between spinal injection and baby delivery
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [minutes]	24	25

19. Secondary Outcome

Title	Time From Baby Delivery to End of Surgery
Description	Time between baby delivery, and the end of surgery
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Mean (Standard Deviation) [minutes]	36.68 (10.19)	38.24 (6.55)

20. Secondary Outcome

Title	Total Blood Loss
Description	Total blood loss (milliliters) during surgery
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [milliliters]	415	485

21. Secondary Outcome

Title	Obstetrician Satisfaction
Description	Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
Time Frame	average 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [score on a scale]	4	4

22. Secondary Outcome

Title	Midwife Satisfaction
Description	Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
Time Frame	72 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Hyperbaric Bupivacaine	Hyperbaric Prilocaine
Arm/Group Description	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 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.
Measure Participants	19	17
Median (Inter-Quartile Range) [score on a scale]	3	4

Adverse Events

Time Frame	Adverse event were collected from spinal injection until 15 Days following the day of surgery.
Arm/Group Title	Hyperbaric Bupivacaine		Hyperbaric Prilocaine
Arm/Group Description	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 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.
All Cause Mortality
	Hyperbaric Bupivacaine		Hyperbaric Prilocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/17 (0%)
Serious Adverse Events
	Hyperbaric Bupivacaine		Hyperbaric Prilocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Hyperbaric Bupivacaine		Hyperbaric Prilocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/19 (42.1%)		8/17 (47.1%)
Gastrointestinal disorders
Nausea	8/19 (42.1%)		7/17 (41.2%)
Nervous system disorders
Transient neurologic symptoms	1/19 (5.3%)		1/17 (5.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.