Spinal Prilocaine for Caesarian Sections

A Prospective Randomized Double Blind Comparison of 7,5 mg Hyperbaric Bupivacaine With 2,5mcg Sufentanyl or 50 mg Hyperbaric Prilocaine With 2,5 mcg Sufentanyl for Caesarean Sections

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.

Study Overview

• Status: Completed
• Conditions: Pain; Bupivacaine; Prilocaine; Combined Spinal Epidural Anesthesia
• Intervention / Treatment: Procedure: combined spinal epidural anaesthesia; Drug: Bupivacaine; Drug: Prilocaine

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

• Study Type: Interventional
• Enrollment (Actual): 182
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • University Hospital Antwerp
  • Antwerp
    • Brasschaat, Antwerp, Belgium
      • AZ Klina
  • Antwerpen
    • Berchem, Antwerpen, Belgium, 2020
      • AZ Middelheim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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%	Procedure: 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; Other Names: Spinal anesthesia; prilocaine; CSE; 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%; Other Names: Marcaine
ACTIVE_COMPARATOR: 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)	Procedure: 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; Other Names: Spinal anesthesia; prilocaine; CSE; Drug: 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); Other Names: Tachipri

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
regression interval of the motor block	Time from spinal injection to a Bromage score of 1 (knee flexion possible)	up to 3 hours
occurrence of hypotension	percentage of study group with hypotension defined as a systolic BP of less than 100 mm Hg or a 20% drop from the baseline level	from spinal injection(T0) to motor block regression ( up to 3 hours)
sensory block level	highest dermatome measured during the study	Up to 3 hours
discharge time maternity ward	the time interval from spinal injection (T0) to discharge to the maternity ward	Up to 3 hours
First Breast feed	the time interval from injection (T0) to first breast feeding	up to 6 hours

Collaborators and Investigators

• Sponsor: University Hospital, Antwerp
• Collaborators: AZ Klina; AZ Middelheim

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2017
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ACTUAL): May 1, 2022

Study Registration Dates

• First Submitted: July 13, 2017
• First Submitted That Met QC Criteria: July 13, 2017
• First Posted (ACTUAL): July 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 4, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: bupivacaine; prilocaine; caesarian section; combined spinal epidural anesthesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics, Local; Anesthetics; Prilocaine; Bupivacaine
• Other Study ID Numbers: ec nr 17/07/77

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No