Fixed Dose Spinal Bupivacaine for Cesarean Delivery

NCT03231436 | Completed

• 1 other identifier: 65/PB/BHorosz/2017
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Anesthesia; Cesarean Section

Keywords

intrathecal bupivacaine; hyperbaric bupivacaine; failed spinal

Outcome Measures

Primary Outcomes (1)

• Adequacy of spinal anesthesia

  Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia

  60min

Secondary Outcomes (2)

• Number of complications

  60min

• Postoperative opioid consumption

  24hours

Study Arms (2)

Fixed dose of 12.5mg bupivacaine

EXPERIMENTAL

Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height.

Drug: Fixed dose of 12.5mg bupivacaine

Height-adjusted dose of bupivacaine

ACTIVE COMPARATOR

Participants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl

Drug: Height-adjusted dose of bupivacaine

Interventions

Fixed dose of 12.5mg bupivacaine DRUG

Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section

Fixed dose of 12.5mg bupivacaine

Height-adjusted dose of bupivacaine DRUG

Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section

Height-adjusted dose of bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bartosz Horosz, MD: lead
• Centre of Postgraduate Medical Education: collaborator

Study Sites (1)

Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care

Warsaw, 01-813, Poland

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Malgorzata Malec-Milewska, MD

  Centre of Postgraduate Medical Education

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2017
• First Posted: July 27, 2017
• Study Start: July 24, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 3, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

PL (1)