NCT05746351

Analgesic Additives to Epidural Bupivacaine in Normal Labor

Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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 .

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor
DRUG	fentanyl	a group will receive epidural Bupivacaine with fentanyl in normal labor
DRUG	Nalbuphine	a group will receive epidural Bupivacaine with Nalbuphine in normal labor

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-03-01
• Completion: 2025-07-01
• First posted: 2023-02-27
• Last updated: 2023-02-27