An interventional study of combined spinal epidural anaesthesia and Prilocaine in Combined Spinal Epidural Anesthesia, Prilocaine and Bupivacaine, sponsored by University Hospital, Antwerp. Completed at 3 sites in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Other
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.
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
University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: Bupivacaine
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 · Drug: Prilocaine
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
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
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
onset time surgical readiness
amount of minutes from spinal injection (T0) to loss of cold sensation on the fifth thoracic dermatome
Time frame: from start spinal anaesthesia to start of surgery (up to 30 minutes)
regression interval of the motor block
Time from spinal injection to a Bromage score of 1 (knee flexion possible)
Time frame: 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
Time frame: from spinal injection(T0) to motor block regression ( up to 3 hours)
sensory block level
highest dermatome measured during the study
Time frame: Up to 3 hours
discharge time maternity ward
the time interval from spinal injection (T0) to discharge to the maternity ward
Time frame: Up to 3 hours
First Breast feed
the time interval from injection (T0) to first breast feeding
Time frame: up to 6 hours
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp