Clinical trial NCT03231436: Fixed Dose Spinal Bupivacaine for Cesarean Delivery
Official title: Fixed Dose Versus Height - Adjusted Dose of Intrathecal Hyperbaric Bupivacaine With Opioid for Cesarean Delivery: a Prospective Double-blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Cesarean Section
Keywords: intrathecal bupivacaine
hyperbaric bupivacaine
failed spinal
Lead sponsor: Centre of Postgraduate Medical Education
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2017-07-27
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study is designed to compare the effectiveness of spinal anesthesia performed with fixed dose of hyperbaric bupivacaine regardless of patient's height and weight and anesthesia with the dose of bupivacaine that is adjusted to their height. Our clinical experience shows that spinal anesthesia using specific, relatively high dose of hyperbaric bupivacaine combined with opioid is very effective, regardless of parturient's weight and height, provides very good surgical conditions and assures patient's comfort while the rate of anesthesia - related complications is similar or less. Therefore, using height-adjusted protocols, although preferred in some centres, might not be necessary in order to provide good anaesthesia for cesarean delivery. Fixed dose regimen may have some additional advantages in obstetric anesthesia settings, as many of cesareans are performed out of hours, giving less room for mistakes in less experienced hands.

Two groups of parturients undergoing cesarean section are to be compared: anesthetized with fixed-dose regimen (intervention group) and anesthetized with height-adjusted dose regimen (control group). Patients are going to be randomized to one of the above groups, two anesthetists will be involved in anesthetic procedure: anesthetist that looks after the patient throughout the procedure will be blinded to the dose of anesthetic given intrathecally. Therefore his judgment of anesthetic effectiveness is not going to be biased and all patients will receive the same perioperative care in terms of fluid therapy, management of possible anesthesia - related complications and postoperative pain control.

Rate of effective spinal anesthetics, defined as adequate block level and no need for additional intraoperative analgesia has been established as primary outcome measure. Secondary outcome measures are rate of complications and amount of opioids used postoperatively. These are going to be statistically compared.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy above 37Hbd scheduled for elective cesarean section
* ASA 1 or 2

Exclusion Criteria:

* absolute contraindications to spinal anesthesia
* delivery in progress
* non-singleton pregnancy
* BMI\>35
* ultrasound - based estimation of fetal weight below 10 percentile
* pregnancy-induced hypertension
* more than 2 cesarean sections in patient's medical history
* significantly increased risk of obstetric hemorrhage (placenta previa)

Primary outcomes:
measure: Adequacy of spinal anesthesia
timeFrame: 60min
Secondary outcomes:
measure: Number of complications
timeFrame: 60min
measure: Postoperative opioid consumption
timeFrame: 24hours
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Study officials:
affiliation: Centre of Postgraduate Medical Education
name: Malgorzata Malec-Milewska, MD
role: STUDY_CHAIR
References: