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Completed

NCT Number: NCT03219086

Spinal Prilocaine for Caesarian 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

AZ KLina, Brasschaat, Antwerp, Belgium

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

combined spinal epidural anaesthesia

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

Other names: CSE, Spinal anesthesia, prilocaine

Prilocaine

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)

Other names: Tachipri

Bupivacaine

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%

Other names: Marcaine

Primary outcomes

  1. onset time surgical readiness

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

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

Secondary outcomes

  1. regression interval of the motor block

    Time frame: up to 3 hours

    Time from spinal injection to a Bromage score of 1 (knee flexion possible)

  2. occurrence of hypotension

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

    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

  3. sensory block level

    Time frame: Up to 3 hours

    highest dermatome measured during the study

  4. discharge time maternity ward

    Time frame: Up to 3 hours

    the time interval from spinal injection (T0) to discharge to the maternity ward

  5. First Breast feed

    Time frame: up to 6 hours

    the time interval from injection (T0) to first breast feeding

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Collaborators

  • AZ Klina
  • AZ Middelheim

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jul 17, 2017
Registry last updated
Aug 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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