Phase 3
N=40
Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine 2% for Cesarean Section Under Spinal Anesthesia
Pregnant Women · Pain · Hypotension
Bottom Line
View on ClinicalTrials.gov: NCT02973048 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Time to Regression of Motor Block — 180; 130 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hyperbaric bupivacaine (Drug); Hyperbaric prilocaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Regression of Motor Block |
180; 130 | — |
| SECONDARY Time to Successful Anesthesia (Successful Sensory Block) |
9.63; 11.18 | — |
| SECONDARY Number of Participants Per Maximal Level of Sensory Block Attained After Spinal Anesthesia |
0; 1; 3; 1; 0; 0 | — |
| SECONDARY Time to Resolution of Sensory Block |
212.95; 169.59 | — |
| SECONDARY Time to Motor Block Onset |
16; 10 | — |
| SECONDARY Number of Patients With Hypotension and Use of Vasopressors |
17; 9; 16; 10 | — |
| SECONDARY Number of Participants With Urinary Retention |
2; 2 | — |
| SECONDARY Time to First Walk |
318; 198 | — |
| SECONDARY Maternal Satisfaction Assessed by Visual Analogic Scale (VASS) |
9; 9 | — |
| SECONDARY Maternal Rehabilitation Assessed by Visual Analogic Scale (VASR) |
9; 9 | — |
| SECONDARY Number of Participants With Adverse Events (Nausea, Vomiting, Pruritis, Headache) |
18; 13; 1; 1; 0; 3 | — |
| SECONDARY Number of Participants With Transient Neurologic Symptoms (TNS) |
0; 0 | — |
| SECONDARY Pain as Assessed by Visual Analogue Scale |
13; 7; 6; 9; 0; 1 | — |
| SECONDARY Newborn Apgar Score |
9; 9; 10; 10; 10; 10 | — |
| SECONDARY Newborn Methemoglobinemia (MetHb) |
1.8; 1.7 | — |
| SECONDARY Newborn Umbilical pH |
7.33; 7.32 | — |
| SECONDARY Time of Surgery |
45; 50 | — |
| SECONDARY Time From Spinal Injection to Baby Delivery |
24; 25 | — |
| SECONDARY Time From Baby Delivery to End of Surgery |
36.68; 38.24 | — |
| SECONDARY Total Blood Loss |
415; 485 | — |
| SECONDARY Obstetrician Satisfaction |
4; 4 | — |
| SECONDARY Midwife Satisfaction |
3; 4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists physical status (ASA) 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
Data sourced from ClinicalTrials.gov (NCT02973048). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.