AnesthesiaPhase 4NCT03956303
Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
A Phase 4 study testing Chirocaine %0.5, Chirocaine Heavy 40 and Chirocaine Heavy 60 in people with Anesthesia, run by Balikesir University.
Trial summary
The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Chirocaine %0.5, Chirocaine Heavy 40 and Chirocaine Heavy 60
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II
- Pregnancy at Term
- Scheduled for elective caesarean delivery
Who cannot join
- contraindication for spinal anesthesia
- drug allergy
- pregnancy related disorders (hypertension, placenta previa, fetal problems)
About this study
Official title: Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.
The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.
Read the detailed description
Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens.
Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.
Baby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.
Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.
The surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.
The patient will evaluate spinal block analgesia quality as good, medium or poor.
Pain scores are going to be evaluated by VAS at the beginning, uterine incision and during abdominal closure. Time for first analgesic requirement and postoperative pain is also going to be evaluated by VAS.
- Conditions
- Anesthesia
- Being tested
- Chirocaine %0.5, Chirocaine Heavy 40, Chirocaine Heavy 60, Chirocaine Heavy 80
- Keywords
- Anesthesia, Spinal, Cesarean Section, Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chirocaine %0.5Drug
Also called Plain levobupivacaine, Group 1
Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
Chirocaine Heavy 40Drug
Also called levobupivacaine heavy 40, Group 2
Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
Chirocaine Heavy 60Drug
Also called levobupivacaine heavy 60, Group 3
Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
Chirocaine Heavy 80Drug
Also called levobupivacaine heavy 80, Group 4
Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Plain Levobupivacaine (Chirocaine (% 0.5) | Active comparator | Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain Receives: Drug: Chirocaine %0.5 |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 40 | Active comparator | Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40 Receives: Drug: Chirocaine Heavy 40 |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 60 | Active comparator | Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60 Receives: Drug: Chirocaine Heavy 60 |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 80 | Active comparator | Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80 Receives: Drug: Chirocaine Heavy 80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test
time to reach T10 sensory block by pinprick test
Measured: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected.
Spinal Block Quality by questioning
the intensity of spinal block will be evaluated via questioning the surgeon and the patient. the surgeon will grade the abdominal relaxivity as good, medium or poor The patient will evaluate spinal block analgesia quality as good, medium or poor.
Measured: At the end of surgery
Change the sensory block level at intraoperative period by pinprick test
the level of maximum sensory block by pinprick test
Measured: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The highest measured level by pinprick test be recorded
time to reach maximum level of sensory block at intraoperative period by pinprick test
time to reach maximum level of sensory block by pinprick test
Measured: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. the time to reach the highest measured by pinprick test will be recorded.
Change over time at the level of sensory block at intraoperative period by pinprick test
time to two segment regression of maximum sensory block by pinprick test
Measured: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The time to two segment regression of maximum sensory block by pinprick test will be recorded.
Change in motor block level from PACU to discharge
motor block recovery time by bromage scale
Measured: every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale
Change to regression of sensory block by pinprick test
time to S2 regression of sensory block by pinprick test
Measured: In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours
Secondary outcomes (3)
Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure
measurement of systolic , diastolic and mean arterial blood pressure
Measured: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. every 30 minutes up to 2 hours
Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone
postoperative complications ( head ache, back pain, numbness of lower extremity )by phone
Measured: on postoperative day 3 by phone.
evaluation of umbilical vein blood gas analysis
umbilical vein blood sample will be obtained immediately after delivery of the fetus and will a blood gas analysis will be performed
Measured: immediately after fetus delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study startJun 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sagir, MD, Balikesir University
- Investigators
- Ozlem Sagir, Assist. Prof, Study director, Balikesir University School of Medicine Department of Anesthesia and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03956303
- Sponsor's protocol ID
- osagir2
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery.
- ClinicalTrials.gov ID
- NCT03956303
- Acronym / sponsor ID
- osagir2
- Conditions
- Anesthesia
- Keywords
- Anesthesia, Spinal, Cesarean Section, Levobupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 20 May 2019 (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 investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.
Detailed description
Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal anesthesia was performed with one of the following regimens.
Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction motor block was evaluated via bromage scale and sensory block via pinprick test every 3 minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block level, time to reach maximum block level, time needed to achieve T10 sensory level were recorded.
Baby delivery time, and operation duration were also recorded. Time to two segment regression of maximum sensory block, motor block recovery time and time to S2 regression of sensory block will be recorded.
Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same evaluation periods and postoperative period.
The surgeon will also evaluate the abdominal relaxation surgical block quality as good, medium and poor.
The patient will evaluate spinal block analgesia quality as good, medium or poor.
Pain scores are going to be evaluated by VAS at the beginning, uterine incision and during abdominal closure. Time for first analgesic requirement and postoperative pain is also going to be evaluated by VAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Plain Levobupivacaine (Chirocaine (% 0.5) | Active comparator | Drug: Chirocaine %0.5Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 40 | Active comparator | Drug: Chirocaine Heavy 40Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40 |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 60 | Active comparator | Drug: Chirocaine Heavy 60Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60 |
| Levobupivacaine (Chirocaine % 0,75) + dextrose 80 | Active comparator | Drug: Chirocaine Heavy 80Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-II
- Pregnancy at Term
- Scheduled for elective caesarean delivery
Key exclusion criteria (3 listed)
- contraindication for spinal anesthesia
- drug allergy
- pregnancy related disorders (hypertension, placenta previa, fetal problems)
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 |
|---|---|---|
| Chirocaine %0.5Also: Plain levobupivacaine, Group 1Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl | Drug | Plain Levobupivacaine (Chirocaine (% 0.5) |
| Chirocaine Heavy 40Also: levobupivacaine heavy 40, Group 2Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl | Drug | Levobupivacaine (Chirocaine % 0,75) + dextrose 40 |
| Chirocaine Heavy 60Also: levobupivacaine heavy 60, Group 3Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl | Drug | Levobupivacaine (Chirocaine % 0,75) + dextrose 60 |
| Chirocaine Heavy 80Also: levobupivacaine heavy 80, Group 4Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl | Drug | Levobupivacaine (Chirocaine % 0,75) + dextrose 80 |
Primary outcome
Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test
Time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected.
time to reach T10 sensory block by pinprick test
Spinal Block Quality by questioning
Time frame: At the end of surgery
the intensity of spinal block will be evaluated via questioning the surgeon and the patient. the surgeon will grade the abdominal relaxivity as good, medium or poor The patient will evaluate spinal block analgesia quality as good, medium or poor.
Change the sensory block level at intraoperative period by pinprick test
Time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The highest measured level by pinprick test be recorded
the level of maximum sensory block by pinprick test
time to reach maximum level of sensory block at intraoperative period by pinprick test
Time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. the time to reach the highest measured by pinprick test will be recorded.
time to reach maximum level of sensory block by pinprick test
Change over time at the level of sensory block at intraoperative period by pinprick test
Time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. The time to two segment regression of maximum sensory block by pinprick test will be recorded.
time to two segment regression of maximum sensory block by pinprick test
Change in motor block level from PACU to discharge
Time frame: every 15 minutes until end of surgery and 30 minutes postoperatively up to 2 hours by Bromage Scale
motor block recovery time by bromage scale
Change to regression of sensory block by pinprick test
Time frame: In the postoperative period, changes in sensory block level will be recorded at 30 min intervals up to 2 hours
time to S2 regression of sensory block by pinprick test
3 secondary outcomes
Haemodynamic evaluation by mmHg for systolic , diastolic and mean arterial blood pressure
Time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia. every 30 minutes up to 2 hours
Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone
Time frame: on postoperative day 3 by phone.
evaluation of umbilical vein blood gas analysis
Time frame: immediately after fetus delivery
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 20 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.
Ozlem Sagir, Assist. Prof study director
Balikesir University School of Medicine Department of Anesthesia and Reanimation
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chirocaine %0.5, Chirocaine Heavy 40 and Chirocaine Heavy 60 in people with Anesthesia, run by Balikesir University.
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 3 inclusion and 3 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 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change of time to reach T10 sensory spinal block level at intraoperative period by pinprick test (time frame: Every 3 minutes for 15 minutes and every 5 minutes afterwards up to 60 minutes after induction of spinal anesthesia.In these evaluation periods, the sensory block will be recorded when the T10 is detected.). The study lists 7 primary outcomes in all. 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 20 May 2019.