Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed dose of 12.5mg bupivacaine | Experimental | Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height. |
|
| Height-adjusted dose of bupivacaine | Active Comparator | Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fixed dose of 12.5mg bupivacaine | Drug | Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adequacy of spinal anesthesia | Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia | 60min |
| Measure | Description | Time Frame |
|---|---|---|
| Number of complications | Hypotension, bradycardia, nausea, vomiting, | 60min |
| Postoperative opioid consumption | Time to the first dose of morphine and total amount of morphine used postoperatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Malgorzata Malec-Milewska, MD | Centre of Postgraduate Medical Education | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care | Warsaw | 01-813 | Poland |
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Height-adjusted dose of bupivacaine | Drug | Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section |
|
| 24hours |
| D000588 |
| Amines |