Intrathecal Analgesia for Normal Labour

Status Not yet recruiting

Clinical Trial Summary

Primary outcome: Compare the duration of analgesia. Secondary outcome: analgesic potency of bupivacaine and fentanyl versus levobupivacaine and fentanyl.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Labor Pain

Clinical Trial Details

NCT number	NCT04221568
Study type	Interventional
Source	Assiut University
Contact	peter elesha
Phone	+201207674699
Email	peter_hero14@yahoo.com
Status	Not yet recruiting
Phase	Phase 1
Start date	March 1, 2020
Completion date	March 1, 2021

View Details

See also
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Completed	`NCT02885350` - Spinal or Epidural Fentanyl or Sufentanil for Labour Pain in Early Phase of the Labour	Phase 4
Completed	`NCT02550262` - Programmed Intermittent Epidural Bolus for Labor Analgesia During First Stage of Labor	N/A
Completed	`NCT01598506` - Intrathecal Hydromorphone for Labor Analgesia	Phase 2
Withdrawn	`NCT01636999` - Comparing Sedara to Butorphanol in Early Labor	N/A
Completed	`NCT00987441` - Epidural Labor Analgesia and Infant Neurobehavior	N/A
Completed	`NCT00755092` - Effect of Doula in Nulliparas and Multiparas	N/A
Terminated	`NCT00787176` - The Association Between Fluid Administration, Oxytocin Administration, and Fetal Heart Rate Changes	N/A
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Completed	`NCT05327088` - Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia	Phase 2
Completed	`NCT03103100` - Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation	Phase 3
Recruiting	`NCT03623256` - Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia	Phase 4
Active, not recruiting	`NCT02271100` - Assessment of the Use of Ultrasound for Epidural Catheter Placement and Comparison With Palpation Technique	N/A
Completed	`NCT02926469` - Virtual Reality Analgesia in Labor: The VRAIL Pilot Study	N/A
Completed	`NCT03712735` - Programmed Intermittent Epidural Bolus For Laboring Obstetrical Women	Phase 4
Not yet recruiting	`NCT05565274` - Outcome of Combined Tramadol and Paracetamol Versus Pentazocine as Labour Analgesia Among Parturients	N/A
Recruiting	`NCT01708668` - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia	N/A
Recruiting	`NCT02575677` - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.