Fixed Dose Spinal Bupivacaine for Cesarean Delivery (SpinFix-Bupi)

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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Spinal Anesthesia
• Intervention / Treatment: Drug: Fixed dose of 12.5mg bupivacaine; Drug: Height-adjusted dose of bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-813
    • Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fixed dose of 12.5mg bupivacaine; Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height.	Drug: Fixed dose of 12.5mg bupivacaine; Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
ACTIVE_COMPARATOR: Height-adjusted dose of bupivacaine; Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl	Drug: Height-adjusted dose of bupivacaine; Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequacy of spinal anesthesia	Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia	60min

Secondary Outcome Measures

Outcome Measure	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	24hours

Collaborators and Investigators

• Sponsor: Bartosz Horosz, MD
• Collaborators: Centre of Postgraduate Medical Education
• Investigators: Study Chair: Malgorzata Malec-Milewska, MD, Centre of Postgraduate Medical Education

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 24, 2017
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 3, 2019

Study Registration Dates

• First Submitted: July 24, 2017
• First Submitted That Met QC Criteria: July 26, 2017
• First Posted (ACTUAL): July 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2019
• Last Update Submitted That Met QC Criteria: June 8, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: hyperbaric bupivacaine; intrathecal bupivacaine; failed spinal
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 65/PB/BHorosz/2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No