- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973048
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia: a Randomised Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Anderlecht, Belgium, 1070
- Clinique Ste-Anne/St-Remi
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgium, 1000
- University Hospital Saint-Pierre, Université Libre de Bruxelles (ULB)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
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:
|
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.
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Regression of Motor Block
Time Frame: 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
|
until complete regression of motor block (up to 4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Successful Anesthesia (Successful Sensory Block)
Time Frame: From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
|
Time between spinal injection and reached bilateral T4 sensory level.
|
From spinal injection of the local anesthetic to bilateral T4 level (average 20 minutes)
|
Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia
Time Frame: 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. |
until complete release of sensory block (T12-S1) (average 4 hours)
|
Time to Resolution of Sensory Block
Time Frame: 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).
|
until complete release of sensory block (T12-S1) (average 4 hours)
|
Time to Motor Block Onset
Time Frame: 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
|
From spinal injection of the local anesthetic to bilateral T4 level and during surgery (average 1 hour)
|
Number of Patients With Hypotension and Use of Vasopressors
Time Frame: 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)
|
up to 2 hours after surgery
|
Number of Participants With Urinary Retention
Time Frame: up to 4 hours after surgery
|
All parturients will be questioned and examined for urinary retention (yes or no)
|
up to 4 hours after surgery
|
Time to First Walk
Time Frame: 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.
|
up to 24h after surgery
|
Maternal Satisfaction Assessed by Visual Analogic Scale (VASS)
Time Frame: 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)
|
up to 24 hours after surgery
|
Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR)
Time Frame: 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)
|
up to 72 hours after surgery
|
Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache)
Time Frame: 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)
|
up to 72 hours after surgery
|
Number of Participants With Transient Neurologic Symptoms (TNS)
Time Frame: 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.
|
up to 15 Days after surgery
|
Pain as Assessed by Visual Analogue Scale
Time Frame: 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.
|
up to 24 hours after surgery
|
Newborn Apgar Score
Time Frame: 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). |
up to 10 minutes after baby extraction
|
Newborn Methemoglobinemia (MetHb)
Time Frame: 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. |
average 1 hour
|
Newborn Umbilical pH
Time Frame: average 1 hour
|
Newborn umbilical pH will be assessed at delivery by cordal blood sample, as a routine control, and expressed as standard value
|
average 1 hour
|
Time of Surgery
Time Frame: average 1 hour
|
Time between incision and end of surgery
|
average 1 hour
|
Time From Spinal Injection to Baby Delivery
Time Frame: average 1 hour
|
Time between spinal injection and baby delivery
|
average 1 hour
|
Time From Baby Delivery to End of Surgery
Time Frame: average 1 hour
|
Time between baby delivery, and the end of surgery
|
average 1 hour
|
Total Blood Loss
Time Frame: average 1 hour
|
Total blood loss (milliliters) during surgery
|
average 1 hour
|
Obstetrician Satisfaction
Time Frame: average 1 hour
|
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at the end of surgery
|
average 1 hour
|
Midwife Satisfaction
Time Frame: 72 hours after surgery
|
Satisfaction ranged between 1 (totally unsatisfied) to 4 (totally satisfied) assessed at postoperative Day 3
|
72 hours after surgery
|
Collaborators and Investigators
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)
Publications and helpful links
General 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. doi: 10.1093/bja/aeg251.
- 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.
- 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. No abstract available.
- Goffard P, Leloup R, Vercruysse Y, Fils JF, Gautier PE, Kapessidou Y. Comparison of equipotent doses of intrathecal hyperbaric prilocaine 2% and hyperbaric bupivacaine 0.5% for elective caesarean section: A prospective, randomised, controlled, two-centre clinical trial. Eur J Anaesthesiol. 2022 Mar 1;39(3):227-235. doi: 10.1097/EJA.0000000000001548.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B076201627677
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
Clinical Trials on Hyperbaric bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
University of AlexandriaCompleted
-
Hamdard UniversityCompletedHaemodynamic InstabilityPakistan
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
Ankara City Hospital BilkentNot yet recruiting
-
Guy's and St Thomas' NHS Foundation TrustObstetric Anaesthetists' AssociationRecruitingCervical Incompetence in Pregnancy as Antepartum ConditionUnited Kingdom
-
Mahidol UniversityCompletedAnalgesia | Spinal Anesthesia | Transurethral Resection of Prostate
-
Indonesia UniversityCompletedPostoperative Complications | Cesarean Section | Spinal Anesthesia | Hypotension Drug-InducedIndonesia
-
Helwan UniversityCompletedSpinal Anesthesia | Lower Abdominal Surgery | Hyperbaric Bupivacaine | Isobaric BupivacaineEgypt
-
Dr. Soliman Fakeeh HospitalCompleted