NCT03219086

Brief Summary

Prilocaine theoretically could provide faster onset because of its lower pKa (7,7) compared to bupivacaine (8,1). The primary objective of this prospective double blind randomized trial is to determine block onset of spinal hyperbaric prilocaine compared to bupivacaine, both with a small dose of sufentanyl as an additive.The primary hypothesis is that a significant larger amount of patients will gain surgical readiness within 8 minutes after spinal injection of prilocaine with sufentanyl compared to bupivacaine with sufentanyl. Surgical readiness is defined as a sensory block level of T5 tested by loss of cold sensation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

4.8 years

First QC Date

July 13, 2017

Last Update Submit

August 4, 2022

Conditions

Combined Spinal Epidural AnesthesiaPrilocaineBupivacainePain

Keywords

combined spinal epidural anesthesiacaesarian sectionprilocainebupivacaine

Outcome Measures

Primary Outcomes (1)

  • onset time surgical readiness

    amount of minutes from spinal injection (T0) to loss of cold sensation on the fifth thoracic dermatome

    from start spinal anaesthesia to start of surgery (up to 30 minutes)

Secondary Outcomes (5)

  • regression interval of the motor block

    up to 3 hours

  • occurrence of hypotension

    from spinal injection(T0) to motor block regression ( up to 3 hours)

  • sensory block level

    Up to 3 hours

  • discharge time maternity ward

    Up to 3 hours

  • First Breast feed

    up to 6 hours

Study Arms (2)

Group M

ACTIVE COMPARATOR

combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%

Procedure: combined spinal epidural anaesthesiaDrug: Bupivacaine

Group P

ACTIVE COMPARATOR

A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)

Procedure: combined spinal epidural anaesthesiaDrug: Prilocaine

Interventions

combined spinal epidural anaesthesiaPROCEDURE

To give surgical anesthesia for performance of the caesarian section a combined spinal epidural anesthesia will be performed with different spinal solutions according to the appointed study group

Also known as: CSE, Spinal anesthesia, prilocaine
Group MGroup P
PrilocaineDRUG

A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)

Also known as: Tachipri
Group P
BupivacaineDRUG

combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%

Also known as: Marcaine
Group M

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A term Pregnant women (37-42 weeks)scheduled for caesarian section

You may not qualify if:

  • Patient refusal
  • Twin or multiple pregnancy
  • Preeclampsia
  • Contraindication neuraxial technique
  • Indication general anaesthesia
  • BMI before pregnancy \>35
  • Maternal height \<155 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

AZ Middelheim

Berchem, Antwerpen, 2020, Belgium

Location

AZ KLina

Brasschaat, Antwerp, Belgium

Location

University Hospital Antwerp

Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, SpinalPrilocaineBupivacaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The spinal solution will be prepared by an independent anaesthetist, anaesthetist trainee or research nurse on a sterile table after opening the sealed envelope with the appointed study group. The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: prospective double blind randomised
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 17, 2017

Study Start

August 1, 2017

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

August 5, 2022

Record last verified: 2022-08

Locations

BE(3)