- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04221568
Intrathecal Analgesia for Normal Labour
The Comparison of Intrathecal Bupivacaine With Fentanyl and Levobupivacaine With Fentanyl for Labour Analgesia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The pain of childbirth is the most severe pain any women can endure in their life time. Painful uterine contractions lead to maternal hyperventilation and increased catecholamine concentrations resulting im maternal and fetal hypoxemia.
Labour pain when unrelieved can have adverse effect on the course of labour as well as on the fetal wellbeing. An effective labour analgesia lead to better fetal and maternal outcome.
Although the gold standard in labour analgesia is utilization of epidural services which are widely used to provide pain-free labour in many parts of the world and and have the advantage of providing flexibility to meet the needs of each patient . Epidurals have long been associated with increased oxytocin use, increased fetal malposition, increased rates of instrumental and cesarian delivery, and longer labour .
The use of single-shot intrathecal low dose found to be effective . The advantages of this form of technique include the rapidity of onset and reliability, with minimal hemodynamic changes and motor block. Spinal block is cheaper as well as less technically challenging when compared to epidural and combined spinal epidural block. Intrathecal analgesia alone is useful when duration of labour can be reasonably estimated. Opioid combined with a small dose of local anesthetic provides rapid analgesia and dissipates when no longer needed.
Bupivacaine because of its least placental transfer, due to high protein binding and minimal motor block compared to sensory block in lower doses, has become the popular choice for labor analgesia. Addition of neuraxial lipid soluble opioids permitted reduction in the dose while maintaining effective analgesia and minimizing potential adverse effects on the progress of labor and lower extremity motor block .
Levobupivacaine is the S (-) enantiomer of racemic bupivacaine. Previous studies have shown that it exhibits a clinical profile similar to bupivacaine with the added advantage of less motor impairment .
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: peter elesha
- Phone Number: +201207674699
- Email: peter_hero14@yahoo.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- singleton pregnancies
- vertex presentation who will be in the active phase of labour with a cervical dilatation >4cm
- normal fetal heart rate.
Exclusion Criteria:
- 1-Parturients with systemic diseases 2-Suspected cesarian section which include, in order of frequency, labor dystocia, abnormal or indeterminate (formerly, nonreassuring) fetal heart rate tracing, fetal malpresentation, multiple gestation, and suspected fetal macrosomia.
- 3 Fetus with known or suspected congenital abnormalities, and 4-Administration of parentral or oral analgesics before initiation of neuraxial analgesia will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare the duration of analgesia of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
Time Frame: From2 to 8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)
|
Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.
|
From2 to 8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.
Time Frame: From2-8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)
|
Defined as the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed.
|
From2-8 hours. It is the time between the end of the spinal injection and the moment additional analgesia requested by parturients owing to the reappearance of labor pain was assessed by Visual Analog Scale for Pain (VAS Pain)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: hamdy abbas, Assiut University
- Study Director: wesam nashat, Assiut University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Labor Pain
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Bupivacaine
- Levobupivacaine
Other Study ID Numbers
- Analgesia in normal labour
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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