Combined Spinal Epidural Anesthesia, Prilocaine, Bupivacaine, Pain
Conditions
Keywords
combined spinal epidural anesthesia, caesarian section, prilocaine, bupivacaine
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
Interventions
PROCEDUREcombined 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
DRUGPrilocaine
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)
DRUGBupivacaine
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%
Sponsors
AZ Klina
AZ Middelheim
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
prospective double blind randomised
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| onset time surgical readiness | 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
| Measure | Time frame | Description |
|---|---|---|
| regression interval of the motor block | up to 3 hours | Time from spinal injection to a Bromage score of 1 (knee flexion possible) |
| occurrence of hypotension | 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 |
| sensory block level | Up to 3 hours | highest dermatome measured during the study |
| discharge time maternity ward | Up to 3 hours | the time interval from spinal injection (T0) to discharge to the maternity ward |
| First Breast feed | up to 6 hours | the time interval from injection (T0) to first breast feeding |
Countries
Belgium
Outcome results
None listed