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Estimation of the ED95 of Intrathecal Hyperbaric Prilocaine 2% With Sufentanyl for Scheduled Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03036384
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : April 20, 2020
Last Update Posted : May 6, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Saint Pierre

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pregnant Women
Interventions Drug: HB Prilocaine 2% (varying dose)
Drug: HB Prilocaine 2%
Drug: Sufentanil
Drug: Morphine
Enrollment 40
Recruitment Details All participants were recruited at CHU Saint-Pierre.
Pre-assignment Details Possible doses of HB prilocaine range from 30 to 55mg, but actual administrated doses will be defined by CRM
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10
Hide Arm/Group Description 45mg HB prilocaine initial dose; 4 patients 40mg HB prilocaine following CRM results; 4 patients 40mg HB prilocaine following CRM results; 4 patients 35mg HB prilocaine following CRM results; 4 patients 50mg HB prilocaine following CRM results, 4 patients 45mg HB prilocaine following CRM results, 4 patients 45mg HB prilocaine following CRM results, 4 patients 45mg HB prilocaine following CRM results, 4 patients 40mg HB prilocaine following CRM results, 4 patients 45mg HB prilocaine following CRM results, 4 patients
Period Title: Overall Study
Started 4 4 4 4 4 4 4 4 4 4
Completed 4 4 4 4 4 4 4 4 4 4
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title 35mg HB Prilocaine 40mg HB Prilocaine 45mg HB Prilocaine 50mg HB Prilocaine Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 4 12 20 4 40
Hide Baseline Analysis Population Description
Statistical analysis (Mean +/- SD) was realized for the total number of patients for each dose proposed by CRM.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
29  (8.76) 35.08  (5.11) 32.85  (4.93) 29.85  (5.94) 32.75  (5.69)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
Female
4
 100.0%
12
 100.0%
20
 100.0%
4
 100.0%
40
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Length  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
159.5  (4.93) 164.42  (4.45) 162.8  (6.26) 157  (6.16) 162.38  (5.89)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
73  (16.02) 82.17  (11.93) 79.78  (11.6) 84.68  (2.88) 80.31  (11.62)
Gravity  
Mean (Standard Deviation)
Unit of measure:  Number of pregnancies
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
3  (1.41) 2.17  (1.03) 3.1  (1.98) 2  (0.96) 2.70  (1.47)
Parity  
Mean (Standard Deviation)
Unit of measure:  Number of deliveries
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
1.25  (0.5) 0.67  (0.49) 1.3  (1.98) 0.75  (0.96) 1.05  (1.47)
Previous Caesarean Section (CS)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
no previous caeserean
2
  50.0%
7
  58.3%
10
  50.0%
3
  75.0%
22
  55.0%
1 previous caeserean
2
  50.0%
5
  41.7%
10
  50.0%
1
  25.0%
18
  45.0%
Term  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 4 participants 12 participants 20 participants 4 participants 40 participants
38.5  (0.58) 38.42  (1.08) 38.40  (0.94) 38.75  (1.26) 38.45  (0.96)
1.Primary Outcome
Title Success of Anesthesia
Hide Description 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
Time Frame during surgery (average 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Cohort 7 Cohort 8 Cohort 9 Cohort 10
Hide Arm/Group Description:
45mg
40mg
40mg
35mg
50mg
45mg
45mg
45mg
40mg
45mg
Overall Number of Participants Analyzed 4 4 4 4 4 4 4 4 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
Success
4
 100.0%
4
 100.0%
4
 100.0%
1
  25.0%
4
 100.0%
4
 100.0%
4
 100.0%
4
 100.0%
3
  75.0%
3
  75.0%
Failure
0
   0.0%
0
   0.0%
0
   0.0%
3
  75.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
1
  25.0%
2.Secondary Outcome
Title Sensitive Block Duration
Hide Description 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).
Time Frame Until complete release of sensory block (T12-S1) (average 4 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Mean (Standard Deviation)
Unit of Measure: hours
2.31  (0.48) 3.25  (0.50)
3.Secondary Outcome
Title Sensitive Block at End of Surgery
Hide Description 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)
Time Frame Until complete release of sensory block (T12-S1) (average 4 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Median (Standard Deviation)
Unit of Measure: Dermatome level
3.88  (1.59) 3.00  (0.82)
4.Secondary Outcome
Title Motor Block Duration
Hide Description 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.
Time Frame Until complete release of motor block (Bromage scale = 1; average 4 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Mean (Standard Deviation)
Unit of Measure: hours
2.75  (0.45) 3.50  (0.58)
5.Secondary Outcome
Title Bromage Motor Block Level at End of Surgery
Hide Description 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.
Time Frame Until complete release of motor block (average 4 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
3.56  (0.51) 4.00  (0.00)
6.Secondary Outcome
Title Newborn Apgar Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Mean (Standard Deviation)
Unit of Measure: score on a scale
Apgar at 1 minute 8.47  (1.84) 9.00  (0.82)
Apgar at 5 minutes 9.63  (0.96) 9.75  (0.50)
Apgar at 10 minutes 9.84  (0.50) 10  (0)
7.Secondary Outcome
Title Newborn Methemoglobinemia (MetHb)
Hide Description Newborn Methemoglobinemia (MetHb) will be assessed at delivery by cordal blood sample, as a routine control, and expressed as a percentage of total hemoglobinemia.
Time Frame average 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 1
Mean (Standard Deviation)
Unit of Measure: percentage of MetHb
1.59  (0.53) 1.60
8.Secondary Outcome
Title Number of Participants Needing Vasopressors
Hide Description

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).

Time Frame during surgery (average 1 hour)
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
15
  78.9%
2
  50.0%
9.Secondary Outcome
Title Number of Participants With Transient Neurologic Symptoms (TNS)
Hide Description 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
Time Frame up to 5 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Nausea or Vomiting
Hide Description 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)
Time Frame up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
3
  15.8%
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Pruritus
Hide Description 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)
Time Frame Up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Urinary Retention
Hide Description All parturients will be questioned for urinary retention (yes or no)
Time Frame Up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Participants With Dizziness
Hide Description All parturients will be questioned for dizziness (yes or no)
Time Frame Up to 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
5
  26.3%
2
  50.0%
14.Secondary Outcome
Title Number of Satisfied Participants
Hide Description Maternal satisfaction (yes or no) will be assessed 1 hour after surgery in the PACU (Post Anesthesia Care Unit)
Time Frame up to 1 hour after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes are presented only for doses of 45 and 50mg HB prilocaine, which are the nearest of the final ED95
Arm/Group Title 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 19 4
Measure Type: Count of Participants
Unit of Measure: Participants
16
  84.2%
4
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 35mg HB Prilocaine 40mg HB Prilocaine 45mg HB Prilocaine 50mg HB Prilocaine
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
35mg HB Prilocaine 40mg HB Prilocaine 45mg HB Prilocaine 50mg HB Prilocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/12 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Hide Serious Adverse Events
35mg HB Prilocaine 40mg HB Prilocaine 45mg HB Prilocaine 50mg HB Prilocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/12 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
35mg HB Prilocaine 40mg HB Prilocaine 45mg HB Prilocaine 50mg HB Prilocaine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/12 (0.00%)   0/20 (0.00%)   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Panayota Kapessidou
Organization: Centre Hospitalier Universitaire Saint Pierre
Phone: +32.2.535 ext 3750
EMail: pkapessi@ulb.ac.be
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire Saint Pierre
ClinicalTrials.gov Identifier: NCT03036384    
Other Study ID Numbers: NB076201627436
First Submitted: January 12, 2017
First Posted: January 30, 2017
Results First Submitted: March 20, 2020
Results First Posted: April 20, 2020
Last Update Posted: May 6, 2020