Spinal Prilocaine for Caesarian Sections

NCT ID: NCT03219086

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2022-05-01

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.

Detailed Description

This study is designed as a randomised prospective double blind multi centre study.

Following approval by the Hospital Ethics committee of the University Hospital Antwerp and all participating hospitals, all-in term (37-42 weeks of gestation) pregnant women planned for a caesarean section will be asked to participate in this trial.

Patients will be randomised to receive either spinal prilocaine with sufentanyl or spinal bupivacaine with sufentanyl.The patient, the anaesthetist performing the CSE and the observer are not aware of the local anaesthetic solution administered.

Preoperative a combined spinal epidural puncture will be performed in the sitting position at the level of L2-L3 or L3-L4 . Vital parameters will be registered at regular intervals. Block characteristics ( onset, duration and intensity of the sensory block and motor block) will be measured at regular intervals.

Patients with insufficient analgesia will receive a top up dose of 5 ml lidocaine 2 % via the epidural catheter.

Time of birth, neonatal outcome (Apgar score 1 min, 5 min and 10 minutes after birth) and admission to the nicu as well as umbilicus venous and arterial blood gasses are recorded.

Patients will be discharged from the PACU when motor block reached a Bromage score 1 Time intervals of discharge to the ward will be registered.At the maternity ward the time of first contact of the baby and the mother and first breast feed (if applicable) will be registered.

One week postoperative patients will be called and asked if they experienced any postoperative symptoms like headache, micturition problems or symptoms resembling Transient Neurological Symptoms

Conditions

Combined Spinal Epidural Anesthesia; Prilocaine; Bupivacaine; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Group M

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%

Group Type: ACTIVE_COMPARATOR

combined spinal epidural anaesthesia

Intervention Type: PROCEDURE

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

Bupivacaine

Intervention Type: DRUG

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%

Group P

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)

Group Type: ACTIVE_COMPARATOR

combined spinal epidural anaesthesia

Intervention Type: PROCEDURE

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

Prilocaine

Intervention Type: DRUG

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)

Interventions

combined spinal epidural anaesthesia

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

Intervention Type: PROCEDURE

Prilocaine

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)

Intervention Type: DRUG

Bupivacaine

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%

Intervention Type: DRUG

Other Intervention Names

CSE; Spinal anesthesia; prilocaine; Tachipri; Marcaine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AZ Klina

OTHER

Sponsor Role: collaborator

AZ Middelheim

UNKNOWN

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Dr M. B. Breebaart

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AZ Middelheim

Berchem, Antwerpen, Belgium

AZ KLina

Brasschaat, Antwerp, Belgium

University Hospital Antwerp

Antwerp, , Belgium

Countries

Belgium

Other Identifiers

ec nr 17/07/77

Identifier Type: -

Identifier Source: org_study_id