Health CarePhase 4NCT02025374
Hyperbaric Bupivacaine and Hyperbaric Levobupivacaine in C/S
A Phase 4 study testing Hyperbaric levobupivacaine and Hyperbaric bupivacaine % 0.5 in people with Health Care and Drugs, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Health Care, Drugs
- What is being tested?
- Hyperbaric levobupivacaine and Hyperbaric bupivacaine % 0.5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Aug 2016
- Phase
- Phase 4
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- elective cesarean section no other coexisting medical situation
Who cannot join
- known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Balıkesir University Faculty of Medicine
Balıkesir, 10145
About this study
Official title: The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section
Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.
Read the detailed description
Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia are going to be included. Patients with contraindications to regional anesthesia, known allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded from the study.
Patients will not be premedicated. After routine monitorization , IV access and fluid replacement patients will be separated to two groups on a randomised manner. Under sterile conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L 4-5 via epidural-spinal combined including a 27 G spinal needle.
Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.
Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.
The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the patients.
Preparation: 2 ml of %0,75 levobupivacaine + 0,8 mL %30 dextrose + 0,2 mL of saline will be mixed. So it will contain 5 mg levobupivacaine and %8 dextrose per ml.
Hypotension will be defined as a decrease in blood pressure more than % 30 percent of the basal measured systolic arterial pressure. Hypotension will be treated with 250 ml fast saline infusion and if no response with 5 mg of ephedrine IV. A heart rate under 50 beats/min will be defined as bradycardia and will be treated with 0.5 mg atropine i.v.. If the anesthesia is not sufficient 10 ml of % 0.25 levobupivacaine wil be administered through the epidural catheter. The level of sensory and motor block will be evaluated and recorded every 3 minutes at the beginning and after 15 minutes it will be checked every 5 minutes until the end of surgery. Maximum level of sensory block, time to reach T4 dermatome and time to regression of 2 segments will be recorded. Nausea-vomiting, pruritus and shivering will also be recorded. Baby delivery time, which will be defined as the time from spinal medication to clamping of the umbilical cord will also be recorded. Total time of surgery will also be recorded. The time for the first analgesic requirement will be noticed as well. Patient and surgeon satisfaction will also be evaluated.
- Conditions
- Health Care, Drugs
- Being tested
- Hyperbaric levobupivacaine, Hyperbaric bupivacaine % 0.5
- Keywords
- spinal anesthesia, cesarean section, hyperbaric levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric levobupivacaineDrug
Also called Chirocaine %0.75
Hyperbaric bupivacaine % 0.5Drug
Also called Marcaine heavy % 0.5
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric levobupivacaine | Experimental | Group 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally Receives: Drug: Hyperbaric levobupivacaine |
| Hyperbaric bupivacaine | Active comparator | Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally Receives: Drug: Hyperbaric bupivacaine % 0.5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the changes in mean arterial blood pressure between two groups.
Measured: 6 month
Secondary outcomes (1)
Time to reach T4 dermatome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2013
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health CareStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sagir, MD, Balikesir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025374
- Sponsor's protocol ID
- osagir1
- Status last verified
- May 2019
- First submitted
- 12 Dec 2013
- Last updated
- 16 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Hyperbaric Bupivacaine Plus Fentanyl and Hyperbaric Levobupivacaine Plus Fentanyl Administered Intrathecally in Patients Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT02025374
- Acronym / sponsor ID
- osagir1
- Conditions
- Health Care, Drugs
- Keywords
- spinal anesthesia, cesarean section, hyperbaric levobupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Jan 2014 (estimated)
- 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.
Aim of the Study To compare the effects of hyperbaric bupivacaine plus fentanyl with hyperbaric levobupivacaine plus fentanyl on spinal block quality, haemodynamics and need for analgesics in patients undergoing elective cesarean section. Our hypothesis is that hyperbaric levobupivacaine will provide equal block quality, but better haemodynamic conditions compared to hyperbaric bupivacaine.
Detailed description
Material - Method 60 patients, American Society of Anesthesiology (ASA) group I-II, between the ages of 18-45 who were scheduled for elective cesarian section under regional anesthesia are going to be included. Patients with contraindications to regional anesthesia, known allergy, suffering from pregnancy induced hypertension or placenta previa will be excluded from the study.
Patients will not be premedicated. After routine monitorization , IV access and fluid replacement patients will be separated to two groups on a randomised manner. Under sterile conditions spinal anesthesia will be performed in the sitting position at the level L3-4 or L 4-5 via epidural-spinal combined including a 27 G spinal needle.
Group 1 will receive 8 mg hyperbaric bupivacaine plus 20 mcg fentanyl /2ml intrathecally.
Group 2 will receive 8 mg hyperbaric levobupivacaine plus 20 mcg fentanyl/2ml intrathecally.
The Hyperbaric form of Levobupivacaine is not available on market , so it will be prepared with the addition of % 30 dextrose by another anesthesiologist who will be blinded to the patients.
Preparation: 2 ml of %0,75 levobupivacaine + 0,8 mL %30 dextrose + 0,2 mL of saline will be mixed. So it will contain 5 mg levobupivacaine and %8 dextrose per ml.
Hypotension will be defined as a decrease in blood pressure more than % 30 percent of the basal measured systolic arterial pressure. Hypotension will be treated with 250 ml fast saline infusion and if no response with 5 mg of ephedrine IV. A heart rate under 50 beats/min will be defined as bradycardia and will be treated with 0.5 mg atropine i.v.. If the anesthesia is not sufficient 10 ml of % 0.25 levobupivacaine wil be administered through the epidural catheter. The level of sensory and motor block will be evaluated and recorded every 3 minutes at the beginning and after 15 minutes it will be checked every 5 minutes until the end of surgery. Maximum level of sensory block, time to reach T4 dermatome and time to regression of 2 segments will be recorded. Nausea-vomiting, pruritus and shivering will also be recorded. Baby delivery time, which will be defined as the time from spinal medication to clamping of the umbilical cord will also be recorded. Total time of surgery will also be recorded. The time for the first analgesic requirement will be noticed as well. Patient and surgeon satisfaction will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric levobupivacaine | Experimental | Drug: Hyperbaric levobupivacaineGroup 2 Hyperbaric levobupivacaine % 0.5 plus fentanyl; 2 ml total intrathecally |
| Hyperbaric bupivacaine | Active comparator | Drug: Hyperbaric bupivacaine % 0.5Group 1 Hyperbaric bupivacaine % 0.5 plus fentanyl 2 ml intrathecally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- elective cesarean section no other coexisting medical situation
Key exclusion criteria (1 listed)
- known contraindication to regional anesthesia coexisting pregnancy induced problem placental mislocation known allergy
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 |
|---|---|---|
| Hyperbaric levobupivacaineAlso: Chirocaine %0.75 | Drug | Hyperbaric levobupivacaine |
| Hyperbaric bupivacaine % 0.5Also: Marcaine heavy % 0.5 | Drug | Hyperbaric bupivacaine |
Primary outcome
evaluation of the changes in mean arterial blood pressure between two groups.
Time frame: 6 month
1 secondary outcome
Time to reach T4 dermatome
Time frame: 6 months
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 16 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyperbaric levobupivacaine and Hyperbaric bupivacaine % 0.5 in people with Health Care and Drugs, run by Balikesir University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 16 May 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
evaluation of the changes in mean arterial blood pressure between two groups. (time frame: 6 month). 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 16 May 2019.