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Completed

NCT Number: NCT03231436

Fixed Dose Spinal Bupivacaine for Cesarean Delivery

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Warsaw, 01-813, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fixed dose of 12.5mg bupivacaine

Drug

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

Height-adjusted dose of bupivacaine

Drug

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

Primary outcomes

  1. Adequacy of spinal anesthesia

    Time frame: 60min

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

Secondary outcomes

  1. Number of complications

    Time frame: 60min

    Hypotension, bradycardia, nausea, vomiting,

  2. Postoperative opioid consumption

    Time frame: 24hours

    Time to the first dose of morphine and total amount of morphine used postoperatively

Sponsors and collaborators

Lead sponsor

Bartosz Horosz, MD

Other

Collaborators

  • Centre of Postgraduate Medical Education

Registry information

Official study title

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

Acronym: SpinFix-Bupi

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 27, 2017
Registry last updated
Jun 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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