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Hyperbaric bupivacaine 0.5% associated with opioids is the local anesthetic the most commonly used for spinal injection in cesarean section. Nevertheless, its use often results in a long duration of motor nerve block and a haemodynamical instability. Recently developped, the Prilocaine, with its new 2% hyperbaric formulation, seems to offer a good alternative for hyperbaric bupivicaine. A first study has determined the ED95 of hyperbaric prilocaine 2% for intrathecal anesthesia in scheduled cesarean delivery. As opioid adjuvants potentiate the effect of the local anesthetics while decreasing their dose-related side effects, the aim of this study is to determine the ED95 of hyperbaric prilocaine 2% with sufentanyl for scheduled cesarean delivery under spinal anesthesia,by using the Continual Reassessment Method (CRM)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 : HB prilocaine 2%, 45mg | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 2 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 3 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB Prilocaine 2% (varying dose) | Drug | Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl |
| Measure | Description | Time Frame |
|---|---|---|
| Success of Anesthesia | The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision | during surgery (average 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitive Block Duration | Level of Sensory block assessed as loss of sensation to cold, 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). | Until complete release of sensory block (T12-S1) (average 4 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Panayota Kapessidou, MD,PhD | University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB) | Study Director |
| Philippe Goffard, MD | University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB) | Brussels Capital Region | 1000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20529983 | Background | Camponovo C, Fanelli A, Ghisi D, Cristina D, Fanelli G. A prospective, double-blinded, randomized, clinical trial comparing the efficacy of 40 mg and 60 mg hyperbaric 2% prilocaine versus 60 mg plain 2% prilocaine for intrathecal anesthesia in ambulatory surgery. Anesth Analg. 2010 Aug;111(2):568-72. doi: 10.1213/ANE.0b013e3181e30bb8. Epub 2010 Jun 7. | |
| 23393153 |
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Possible doses of HB prilocaine range from 30 to 55mg, but actual administrated doses will be defined by CRM
All participants were recruited at CHU Saint-Pierre.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 45mg HB prilocaine initial dose; 4 patients |
| FG001 | Cohort 2 | 40mg HB prilocaine following CRM results; 4 patients |
| FG002 | Cohort 3 | 40mg HB prilocaine following CRM results; 4 patients |
| FG003 | Cohort 4 | 35mg HB prilocaine following CRM results; 4 patients |
| FG004 | Cohort 5 | 50mg HB prilocaine following CRM results, 4 patients |
| FG005 | Cohort 6 | 45mg HB prilocaine following CRM results, 4 patients |
| FG006 | Cohort 7 | 45mg HB prilocaine following CRM results, 4 patients |
| FG007 | Cohort 8 | 45mg HB prilocaine following CRM results, 4 patients |
| FG008 | Cohort 9 | 40mg HB prilocaine following CRM results, 4 patients |
| FG009 | Cohort 10 | 45mg HB prilocaine following CRM results, 4 patients |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Statistical analysis (Mean +/- SD) was realized for the total number of patients for each dose proposed by CRM.
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| ID | Title | Description |
|---|---|---|
| BG000 | 35mg HB Prilocaine | |
| BG001 | 40mg HB Prilocaine | |
| BG002 | 45mg HB Prilocaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success of Anesthesia | The nerve blockade will be considered as success when a bilateral T4 level will reach in 15 minutes after intrathecal injection without additional epidural injection needed within 45 minutes peri-operative ; no pain at the skin incision, no pain during 45 minutes after the skin incision | Posted | Count of Participants | Participants | during surgery (average 1 hour) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 35mg HB Prilocaine | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Panayota Kapessidou | Centre Hospitalier Universitaire Saint Pierre | +32.2.535 | 3750 | pkapessi@ulb.ac.be |
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| ID | Term |
|---|---|
| D017409 | Sufentanil |
| D009020 | Morphine |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Cohort 4 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 5 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 6 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 7 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 8 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 9 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
| Cohort 10 : HB prilocaine 2%, (30-55mg) | Experimental | Dose-finding study with 4 subjects per dose and a maximum of 40 parturients.To identify the dose to give for reaching the ED95 (effective dose for 95% subjects), Hyperbaric prilocaine 2%, associated with sufentanyl, will be administrated at the dose initial of 45 mg in the cohort 1 (4 subjects), then the dose will be adjusted in the next cohorts using the Continual Reassessment Method (CRM). Possible dose levels are 30, 35, 40, 45, 50, 55mg. |
|
|
| HB Prilocaine 2% | Drug | The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl |
|
|
| Sufentanil | Drug | 2.5µg sufentanyl |
|
| Morphine | Drug | 100 µg Morphine |
|
| Sensitive Block at End of Surgery |
Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level) |
| Until complete release of sensory block (T12-S1) (average 4 hours) |
| Motor Block Duration | Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1. | Until complete release of motor block (Bromage scale = 1; average 4 hours) |
| Bromage Motor Block Level at End of Surgery | Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery. | Until complete release of motor block (average 4 hours) |
| 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). | up to 10 minutes after baby extraction |
| Newborn Methemoglobinemia (MetHb) | Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia. | average 1 hour |
| Number of Participants Needing Vasopressors | Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure. A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia). | during surgery (average 1 hour) |
| Number of Participants With Transient Neurologic Symptoms (TNS) | 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. At Day 0, Day 1, Day 3 and Day 5 | up to 5 Days |
| Number of Participants With Nausea or Vomiting | from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) | up to 24 hours after surgery |
| Number of Participants With Pruritus | from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) | Up to 24 hours after surgery |
| Number of Participants With Urinary Retention | All parturients will be questioned for urinary retention (yes or no) | Up to 24 hours after surgery |
| Number of Participants With Dizziness | All parturients will be questioned for dizziness (yes or no) | Up to 24 hours after surgery |
| Number of Satisfied Participants | Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit) | up to 1 hour after surgery |
| Gupta PK, Chevret S, Zohar S, Hopkins PM. What is the ED95 of prilocaine for femoral nerve block using ultrasound? Br J Anaesth. 2013 May;110(5):831-6. doi: 10.1093/bja/aes503. Epub 2013 Feb 7. |
| 33243149 | Derived | Goffard P, Vercruysse Y, Leloup R, Fils JF, Chevret S, Kapessidou Y. Determination of the ED95 of intrathecal hyperbaric prilocaine with sufentanil for scheduled cesarean delivery: a dose-finding study based on the continual reassessment method. BMC Anesthesiol. 2020 Nov 26;20(1):293. doi: 10.1186/s12871-020-01199-0. |
| BG003 | 50mg HB Prilocaine |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Length | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Gravity | Mean | Standard Deviation | number of pregnancies |
|
| Parity | Mean | Standard Deviation | number of deliveries |
|
| Previous Caesarean Section (CS) | Count of Participants | Participants |
|
| Term | Mean | Standard Deviation | weeks |
|
40mg
| OG003 | Cohort 4 | 35mg |
| OG004 | Cohort 5 | 50mg |
| OG005 | Cohort 6 | 45mg |
| OG006 | Cohort 7 | 45mg |
| OG007 | Cohort 8 | 45mg |
| OG008 | Cohort 9 | 40mg |
| OG009 | Cohort 10 | 45mg |
|
|
| Secondary | Sensitive Block Duration | Level of Sensory block assessed as loss of sensation to cold, 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). | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Mean | Standard Deviation | hours | Until complete release of sensory block (T12-S1) (average 4 hours) |
|
|
|
| Secondary | Sensitive Block at End of Surgery | Level of Sensory block assessed as loss of sensation to cold, 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). For this study, dermatome levels are depicted on a scale ranging from 1 to 18. (1 to 12 = T1-T12 thoracic levels; 13 to 17 = L1-L5 lumbar levels; 18 = S1 sacral level) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Median | Standard Deviation | Dermatome level | Until complete release of sensory block (T12-S1) (average 4 hours) |
|
|
|
| Secondary | Motor Block Duration | Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 minutes after spinal anaesthesia (T0) and until the end of surgery. Duration was defined from the time of the spinal injection until Bromage scale = 1. | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Mean | Standard Deviation | hours | Until complete release of motor block (Bromage scale = 1; average 4 hours) |
|
|
|
| Secondary | Bromage Motor Block Level at End of Surgery | Bromage scale (1 = no motor block; 2 = hip blocked; 3 = hip and knee blocked; and 4 = hip, knee, and ankle blocked) was used to evaluate the motor block every 15 min after spinal anaesthesia (T0) and until the end of surgery. | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Mean | Standard Deviation | score on a scale | Until complete release of motor block (average 4 hours) |
|
|
|
| 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). | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Mean | Standard Deviation | score on a scale | up to 10 minutes after baby extraction |
|
|
|
| Secondary | Newborn Methemoglobinemia (MetHb) | Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia. | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Mean | Standard Deviation | percentage of MetHb | average 1 hour |
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|
|
| Secondary | Number of Participants Needing Vasopressors | Arterial blood pressure will be measured at every 2.5 minute during surgery, then at every 20 minutes in the PACU (Post Anesthesia Care Unit). Vasopressors were given for patients with low blood pressure. A low blood pressure is defined as a blood pressure lower than 20% or more than the basal blood pressure (Systolic blood pressure before spinal anesthesia). | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | during surgery (average 1 hour) |
|
|
|
| Secondary | Number of Participants With Transient Neurologic Symptoms (TNS) | 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. At Day 0, Day 1, Day 3 and Day 5 | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | up to 5 Days |
|
|
|
| Secondary | Number of Participants With Nausea or Vomiting | from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | up to 24 hours after surgery |
|
|
|
| Secondary | Number of Participants With Pruritus | from 15 minutes after spinal anesthesia and every 4 hours for 24 hours (score 0=no symptoms; 1=symptoms with no treatment necessary; 2=symptoms present and treated) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
|
|
|
| Secondary | Number of Participants With Urinary Retention | All parturients will be questioned for urinary retention (yes or no) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
|
|
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| Secondary | Number of Participants With Dizziness | All parturients will be questioned for dizziness (yes or no) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | Up to 24 hours after surgery |
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| Secondary | Number of Satisfied Participants | Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit) | Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95 | Posted | Count of Participants | Participants | up to 1 hour after surgery |
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|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 40mg HB Prilocaine | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | 45mg HB Prilocaine | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | 50mg HB Prilocaine | 0 | 4 | 0 | 4 | 0 | 4 |
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| D009022 |
| Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| Apgar at 10 minutes |
|