Fixed Dose Spinal Bupivacaine for Cesarean Delivery

Cesarean Section Clinical Trial

— SpinFix-Bupi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03231436
• Other study ID #: 65/PB/BHorosz/2017
• Status: Completed
• Phase: N/A
• Start date: July 24, 2017
• Est. completion date: June 3, 2019

Study information

• Verified date: June 2019
• Source: Centre of Postgraduate Medical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: June 3, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cesarean Section
• Spinal Anesthesia

Intervention

Drug:
• Fixed dose of 12.5mg bupivacaine
Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
• Height-adjusted dose of bupivacaine
Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section

Locations

Country	Name	City	State
Poland	Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Bartosz Horosz, MD	Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adequacy of spinal anesthesia	Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia	60min
Secondary	Number of complications	Hypotension, bradycardia, nausea, vomiting,	60min
Secondary	Postoperative opioid consumption	Time to the first dose of morphine and total amount of morphine used postoperatively	24hours