NCT03231436

Fixed Dose Spinal Bupivacaine for Cesarean Delivery

Fixed Dose Versus Height - Adjusted Dose of Intrathecal Hyperbaric Bupivacaine With Opioid for Cesarean Delivery: a Prospective Double-blinded Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Bartosz Horosz, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Anesthesia
• Cesarean Section

Interventions

Type	Name	Description
DRUG	Fixed dose of 12.5mg bupivacaine	Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
DRUG	Height-adjusted dose of bupivacaine	Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section

Timeline

• Start date: 2017-07-24
• Primary completion: 2019-06-01
• Completion: 2019-06-03
• First posted: 2017-07-27
• Last updated: 2019-06-11

Locations

1 site across 1 country: Poland