Analgesic Additives to Epidural Bupivacaine in Normal Labor

Status Not yet recruiting

Clinical Trial Summary

The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.

Clinical Trial Description

Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased . Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction . Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia . Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics. Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings . It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension . Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses . The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression . ;

Study Design

Related Conditions & MeSH terms

Labor Pain

Clinical Trial Details

NCT number	NCT05746351
Study type	Interventional
Source	Assiut University
Contact	Abanob Fathy Zareef, MBBS
Phone	01010424707
Email	bebofathy47@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	March 2023
Completion date	July 2025

View Details

See also
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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
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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	`NCT02575677` - Oxycodone in Treatment of Early Labour Pain Efficacy and Safety
Recruiting	`NCT01708668` - The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia	N/A

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.