Hypotension, Pain, Pregnant Women
Conditions
Keywords
Cesarean delivery, Spinal anesthesia, Local anesthetics
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.
Interventions
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.
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.
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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 |
| 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) |
| 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) |
| 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. |
| 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) |
| 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) |
| 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) |
| 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. |
| 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). |
| 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. |
| 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 |
| Time of Surgery | average 1 hour | Time between incision and end of surgery |
| Time From Spinal Injection to Baby Delivery | average 1 hour | Time between spinal injection and baby delivery |
| Time From Baby Delivery to End of Surgery | average 1 hour | Time between baby delivery, and the end of surgery |
| Total Blood Loss | average 1 hour | Total blood loss (milliliters) during surgery |
| Obstetrician Satisfaction | average 1 hour | Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery |
| Midwife Satisfaction | 72 hours after surgery | Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3 |
| 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. |
Countries
Belgium
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)
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Epidural catheter insertion failure | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Hyperbaric Bupivacaine | Hyperbaric Prilocaine | Total |
|---|---|---|---|
| Age, Continuous | 36.5 years | 32 years | 36 years |
| American Society of Anesthesiologists physical status (ASA) II | 20 Participants | 20 Participants | 40 Participants |
| BMI | 26.37 kg/m^2 | 26.19 kg/m^2 | 26.26 kg/m^2 |
| Gestational Age (GA) | 39 weeks | 39 weeks | 39 weeks |
| Gestity | 2 Pregnancies | 2 Pregnancies | 2 Pregnancies |
| Height | 164 cm | 164 cm | 164 cm |
| Parity | 1 Deliveries | 1 Deliveries | 1 Deliveries |
| Previous c-Section | 13 Participants | 6 Participants | 19 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 40 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 74.8 kg STANDARD_DEVIATION 12.85 | 76.2 kg STANDARD_DEVIATION 13.4 | 75.5 kg STANDARD_DEVIATION 12.98 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 17 |
| other Total, other adverse events | 8 / 19 | 8 / 17 |
| serious Total, serious adverse events | 0 / 19 | 0 / 17 |
Outcome results
Primary
Time to Regression of Motor Block
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Time to Regression of Motor Block | 180 minutes |
| Hyperbaric Prilocaine | Time to Regression of Motor Block | 130 minutes |
Secondary
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) | 9 score on a scale |
| Hyperbaric Prilocaine | Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) | 9 score on a scale |
Secondary
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) | 9 score on a scale |
| Hyperbaric Prilocaine | Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) | 9 score on a scale |
Secondary
Midwife Satisfaction
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
Time frame: 72 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Midwife Satisfaction | 3 score on a scale |
| Hyperbaric Prilocaine | Midwife Satisfaction | 4 score on a scale |
Secondary
Newborn Apgar Score
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Hyperbaric Bupivacaine | Newborn Apgar Score | Apgar at 5 minutes | 10 score on a scale |
| Hyperbaric Bupivacaine | Newborn Apgar Score | Apgar at 1 minute | 9 score on a scale |
| Hyperbaric Bupivacaine | Newborn Apgar Score | Apgar at 3 minutes | 10 score on a scale |
| Hyperbaric Prilocaine | Newborn Apgar Score | Apgar at 5 minutes | 10 score on a scale |
| Hyperbaric Prilocaine | Newborn Apgar Score | Apgar at 1 minute | 9 score on a scale |
| Hyperbaric Prilocaine | Newborn Apgar Score | Apgar at 3 minutes | 10 score on a scale |
Secondary
Newborn Methemoglobinemia (MetHb)
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Newborn Methemoglobinemia (MetHb) | 1.8 percentage of MetHb |
| Hyperbaric Prilocaine | Newborn Methemoglobinemia (MetHb) | 1.7 percentage of MetHb |
Secondary
Newborn Umbilical pH
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Newborn Umbilical pH | 7.33 pH |
| Hyperbaric Prilocaine | Newborn Umbilical pH | 7.32 pH |
Secondary
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
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)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C5 | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C6 | 3 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C7 | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C8 | 2 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T1 | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T2 | 4 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T3 | 7 Participants |
| Hyperbaric Bupivacaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T4 | 3 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T4 | 6 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C5 | 1 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T1 | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C6 | 1 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T3 | 6 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C7 | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome T2 | 2 Participants |
| Hyperbaric Prilocaine | Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia | Sensory level dermatome C8 | 1 Participants |
Secondary
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 0 (no symptom) | 14 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 0 (no symptom) | 18 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 0 (no symptom) | 18 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 1 (symptom with no necessary treatment) | 4 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 1 (symptom with no necessary treatment) | 1 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 2 (symptom present and treated) | 1 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 0 (no symptom) | 18 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 1 (symptom with no necessary treatment) | 1 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 1 (symptom with no necessary treatment) | 1 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 1 (symptom with no necessary treatment) | 3 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Bupivacaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 0 (no symptom) | 16 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 0 (no symptom) | 17 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 0 (no symptom) | 13 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 1 (symptom with no necessary treatment) | 1 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Peroperative | score 2 (symptom present and treated) | 3 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 0 (no symptom) | 12 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 1 (symptom with no necessary treatment) | 5 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 0 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 1 (symptom with no necessary treatment) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 1 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 0 (no symptom) | 17 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 1 (symptom with no necessary treatment) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 2 | score 2 (symptom present and treated) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 0 (no symptom) | 17 Participants |
| Hyperbaric Prilocaine | Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) | Day 3 | score 1 (symptom with no necessary treatment) | 0 Participants |
Secondary
Number of Participants With Transient Neurologic Symptoms (TNS)
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hyperbaric Bupivacaine | Number of Participants With Transient Neurologic Symptoms (TNS) | 0 Participants |
| Hyperbaric Prilocaine | Number of Participants With Transient Neurologic Symptoms (TNS) | 0 Participants |
Secondary
Number of Participants With Urinary Retention
All parturients will be questioned and examined for urinary retention (yes or no)
Time frame: up to 4 hours after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hyperbaric Bupivacaine | Number of Participants With Urinary Retention | 2 Participants |
| Hyperbaric Prilocaine | Number of Participants With Urinary Retention | 2 Participants |
Secondary
Number of Patients With Hypotension and Use of Vasopressors
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Hyperbaric Bupivacaine | Number of Patients With Hypotension and Use of Vasopressors | Hypotension | 17 Participants |
| Hyperbaric Bupivacaine | Number of Patients With Hypotension and Use of Vasopressors | Vasopressors use | 16 Participants |
| Hyperbaric Prilocaine | Number of Patients With Hypotension and Use of Vasopressors | Hypotension | 9 Participants |
| Hyperbaric Prilocaine | Number of Patients With Hypotension and Use of Vasopressors | Vasopressors use | 10 Participants |
Secondary
Obstetrician Satisfaction
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
Time frame: average 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Obstetrician Satisfaction | 4 score on a scale |
| Hyperbaric Prilocaine | Obstetrician Satisfaction | 4 score on a scale |
Secondary
Pain as Assessed by Visual Analogue Scale
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
Population: VAS are presented only at 1 Hour, 2 Hours , 3 Hours and 4 Hours post-surgery
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS >3 (additional analgesic treatment) | 0 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS=0 (no pain) | 13 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS 1-2 (No additional analgesic treatment) | 6 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS=0 (no pain) | 11 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS 1-2 (No additional analgesic treatment) | 6 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS >3 (additional analgesic treatment) | 2 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS=0 (no pain) | 9 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS 1-2 (No additional analgesic treatment) | 7 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS >3 (additional analgesic treatment) | 3 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS=0 (no pain) | 10 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS 1-2 (No additional analgesic treatment) | 7 Participants |
| Hyperbaric Bupivacaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS >3 (additional analgesic treatment) | 2 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS 1-2 (No additional analgesic treatment) | 5 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS >3 (additional analgesic treatment) | 1 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS=0 (no pain) | 9 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS=0 (no pain) | 7 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS=0 (no pain) | 12 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 1 Hour | VAS 1-2 (No additional analgesic treatment) | 9 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS 1-2 (No additional analgesic treatment) | 6 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS=0 (no pain) | 3 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 4 Hours | VAS >3 (additional analgesic treatment) | 0 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS 1-2 (No additional analgesic treatment) | 13 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 3 Hours | VAS >3 (additional analgesic treatment) | 2 Participants |
| Hyperbaric Prilocaine | Pain as Assessed by Visual Analogue Scale | VAS at 2 Hours | VAS >3 (additional analgesic treatment) | 1 Participants |
Secondary
Time From Baby Delivery to End of Surgery
Time between baby delivery, and the end of surgery
Time frame: average 1 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperbaric Bupivacaine | Time From Baby Delivery to End of Surgery | 36.68 minutes | Standard Deviation 10.19 |
| Hyperbaric Prilocaine | Time From Baby Delivery to End of Surgery | 38.24 minutes | Standard Deviation 6.55 |
Secondary
Time From Spinal Injection to Baby Delivery
Time between spinal injection and baby delivery
Time frame: average 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Time From Spinal Injection to Baby Delivery | 24 minutes |
| Hyperbaric Prilocaine | Time From Spinal Injection to Baby Delivery | 25 minutes |
Secondary
Time of Surgery
Time between incision and end of surgery
Time frame: average 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Time of Surgery | 45 minutes |
| Hyperbaric Prilocaine | Time of Surgery | 50 minutes |
Secondary
Time to First Walk
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Time to First Walk | 318 Minutes |
| Hyperbaric Prilocaine | Time to First Walk | 198 Minutes |
Secondary
Time to Motor Block Onset
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Time to Motor Block Onset | 16 minutes |
| Hyperbaric Prilocaine | Time to Motor Block Onset | 10 minutes |
Secondary
Time to Resolution of Sensory Block
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperbaric Bupivacaine | Time to Resolution of Sensory Block | 212.95 minutes | Standard Deviation 51.48 |
| Hyperbaric Prilocaine | Time to Resolution of Sensory Block | 169.59 minutes | Standard Deviation 32.71 |
Secondary
Time to Successful Anesthesia (Successful Sensory Block)
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hyperbaric Bupivacaine | Time to Successful Anesthesia (Successful Sensory Block) | 9.63 minutes | Standard Deviation 3.48 |
| Hyperbaric Prilocaine | Time to Successful Anesthesia (Successful Sensory Block) | 11.18 minutes | Standard Deviation 2.7 |
Secondary
Total Blood Loss
Total blood loss (milliliters) during surgery
Time frame: average 1 hour
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Hyperbaric Bupivacaine | Total Blood Loss | 415 milliliters |
| Hyperbaric Prilocaine | Total Blood Loss | 485 milliliters |