Spinal AnesthesiaSpinFix-BupiNCT03231436
Fixed Dose Spinal Bupivacaine for Cesarean Delivery
A study testing Fixed dose of 12.5mg bupivacaine and Height-adjusted dose of bupivacaine in people with Spinal Anesthesia and Cesarean Section, run by Bartosz Horosz, MD at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Spinal Anesthesia, Cesarean Section
- What is being tested?
- Fixed dose of 12.5mg bupivacaine and Height-adjusted dose of bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 sitePoland
- Study dates
- 24 Jul 2017to 3 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- singleton pregnancy above 37Hbd scheduled for elective cesarean section
- ASA 1 or 2
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Poland1 site
Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care
Warsaw, 01-813
About this study
Official title: 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.
- Conditions
- Spinal Anesthesia, Cesarean Section
- Being tested
- Fixed dose of 12.5mg bupivacaine, Height-adjusted dose of bupivacaine
- Keywords
- intrathecal bupivacaine, hyperbaric bupivacaine, failed spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed dose of 12.5mg bupivacaineDrug
Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
Height-adjusted dose of bupivacaineDrug
Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose of 12.5mg bupivacaine | Experimental | Participants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height. Receives: 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 Receives: Drug: Height-adjusted dose of bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of spinal anesthesia
Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia
Measured: 60min
Secondary outcomes (2)
Number of complications
Hypotension, bradycardia, nausea, vomiting,
Measured: 60min
Postoperative opioid consumption
Time to the first dose of morphine and total amount of morphine used postoperatively
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start24 Jul 2017
- Primary completion1 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartosz Horosz, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Sponsor-investigator, Bartosz Horosz, MD, Centre of Postgraduate Medical Education
- Investigators
- Malgorzata Malec-Milewska, MD, Study chair, Centre of Postgraduate Medical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03231436
- Sponsor's protocol ID
- 65/PB/BHorosz/2017
- Acronym
- SpinFix-Bupi
- Status last verified
- Jun 2019
- First submitted
- 24 Jul 2017
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fixed Dose Versus Height - Adjusted Dose of Intrathecal Hyperbaric Bupivacaine With Opioid for Cesarean Delivery: a Prospective Double-blinded Randomized Trial
- ClinicalTrials.gov ID
- NCT03231436
- Acronym / sponsor ID
- SpinFix-Bupi / 65/PB/BHorosz/2017
- Conditions
- Spinal Anesthesia, Cesarean Section
- Keywords
- intrathecal bupivacaine, hyperbaric bupivacaine, failed spinal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bartosz Horosz, MDUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed dose of 12.5mg bupivacaine | Experimental | Drug: Fixed dose of 12.5mg bupivacaineParticipants that receive the same dose of intrathecal bupivacaine and 25mcg of fentanyl, regardless of their height. |
| Height-adjusted dose of bupivacaine | Active comparator | Drug: Height-adjusted dose of bupivacaineParticipants that receive the dose of intrathecal bupivacaine adjusted to their height and 25mcg of fentanyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- singleton pregnancy above 37Hbd scheduled for elective cesarean section
- ASA 1 or 2
Key exclusion criteria (8 listed)
- absolute contraindications to spinal anesthesia
- delivery in progress
- non-singleton pregnancy
- BMI>35
- ultrasound - based estimation of fetal weight below 10 percentile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fixed dose of 12.5mg bupivacaineSpinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section | Drug | Fixed dose of 12.5mg bupivacaine |
| Height-adjusted dose of bupivacaineSpinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section | Drug | Height-adjusted dose of bupivacaine |
Primary outcome
Adequacy of spinal anesthesia
Time frame: 60min
Level of surgical anesthesia at least T5 and no need for additional intraoperative analgesia
2 secondary outcomes
Number of complications
Time frame: 60min
Postoperative opioid consumption
Time frame: 24hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malgorzata Malec-Milewska, MD study chair
Centre of Postgraduate Medical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed dose of 12.5mg bupivacaine and Height-adjusted dose of bupivacaine in people with Spinal Anesthesia and Cesarean Section, run by Bartosz Horosz, MD at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of spinal anesthesia (time frame: 60min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.