Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05746351 |
| Other study ID # |
epidural additives in labor |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
July 2025 |
Study information
| Verified date |
February 2023 |
| Source |
Assiut University |
| Contact |
Abanob Fathy Zareef, MBBS |
| Phone |
01010424707 |
| Email |
bebofathy47[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
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.
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 .
