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出境医 / 临床实验 / Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
Study Description
Brief Summary:
The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with different density on spinal anesthesia for caesarean delivery.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anesthesia | Drug: Chirocaine %0.5 Drug: Chirocaine Heavy 40 Drug: Chirocaine Heavy 60 Drug: Chirocaine Heavy 80 | Phase 4 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery. |
| Study Start Date : | June 2014 |
| Actual Primary Completion Date : | June 2016 |
| Actual Study Completion Date : | August 2016 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Plain Levobupivacaine (Chirocaine (% 0.5)
Levobupivacaine 8 mg (Chirocaine (% 0.5)) + 20 mcg fentanyl Chirocaine Plain
|
Drug: Chirocaine %0.5
Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
Other Names:
|
|
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 40
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 40 Chirocaine Heavy 40
|
Drug: Chirocaine Heavy 40
Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
Other Names:
|
|
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 60
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 60 Chirocaine Heavy 60
|
Drug: Chirocaine Heavy 60
Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
Other Names:
|
|
Active Comparator: Levobupivacaine (Chirocaine % 0,75) + dextrose 80
Levobupivacaine 8 mg (Chirocaine % 0,75) + 20 mcg fentanyl + dextrose 80 Chirocaine Heavy 80
|
Drug: Chirocaine Heavy 80
Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
Other Names:
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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 ]measurement of systolic , diastolic and mean arterial blood pressure
- Number of participants with postoperative complications ( head ache, back pain, numbness of lower extremity )by phone [ Time Frame: on postoperative day 3 by phone. ]postoperative complications ( head ache, back pain, numbness of lower extremity )by phone
- evaluation of umbilical vein blood gas analysis [ Time Frame: immediately after fetus delivery ]umbilical vein blood sample will be obtained immediately after delivery of the fetus and will a blood gas analysis will be performed
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- ASA I-II
- Pregnancy at Term
- Scheduled for elective caesarean delivery
Exclusion Criteria:
- contraindication for spinal anesthesia
- drug allergy
- pregnancy related disorders (hypertension, placenta previa, fetal problems)
Contacts and Locations
Sponsors and Collaborators
Balikesir University
Investigators
| Study Director: | Ozlem Sagir, Assist. Prof | Balikesir University School of Medicine Department of Anesthesia and Reanimation |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 14, 2019 | ||||
| First Posted Date ICMJE | May 20, 2019 | ||||
| Last Update Posted Date | May 20, 2019 | ||||
| Study Start Date ICMJE | June 2014 | ||||
| Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery. | ||||
| Official Title ICMJE | Comparison of the Efficacy of 3 Different Density Levobupivacaine Solutions + Fentanyl Applied Intrathecally for Spinal Anesthesia in Caesarean Delivery. | ||||
| Brief Summary | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Anesthesia | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
100 | ||||
| Original Actual Enrollment ICMJE | Same as current | ||||
| Actual Study Completion Date ICMJE | August 2016 | ||||
| Actual Primary Completion Date | June 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03956303 | ||||
| Other Study ID Numbers ICMJE | osagir2 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Ozlem Sagir, MD, Balikesir University | ||||
| Study Sponsor ICMJE | Balikesir University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Balikesir University | ||||
| Verification Date | May 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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