Analgesic Additives to Epidural Bupivacaine in Normal Labor
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
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 .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: epidural Bupivacaine with Dexmedetomidine in normal labor Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml |
Drug: Dexmedetomidine
a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor
Other Names:
|
| Active Comparator: epidural Bupivacaine with fentanyl in normal labor Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml. |
Drug: fentanyl
a group will receive epidural Bupivacaine with fentanyl in normal labor
Other Names:
|
| Active Comparator: epidural Bupivacaine with Nalbuphine in normal labor Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine. |
Drug: Nalbuphine
a group will receive epidural Bupivacaine with Nalbuphine in normal labor
Other Names:
|
Outcome Measures
Primary Outcome Measures
- VAS score for pain [before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.]
changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
/= 18 years of age
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American Society of Anesthesiologists (ASA) Physical Status 2 or 3
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Full term pregnancy (>37 gestational weeks)
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Planning vaginal delivery
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Planning epidural labor analgesia
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Vertex presentation
Exclusion Criteria:
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Patient refusal to epidural analgesia,
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Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
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Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
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hemodynamic instability, severe aortic or mitral stenosis)
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Severe pre-eclampsia,
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Breech presentations
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Antepartum hemorrhage
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Cephalopelvic disproportion
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Body mass index ≥40 kg/m2.
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Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac]
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Known or suspected fetal abnormalities
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Inability to communicate or participate in study procedures
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Assiut University
Investigators
- Study Chair: Zein EA Zareh Hassan, professor, Assiut University
- Study Director: Elwani Eldramy Elsenosi, professor, Assiut University
- Principal Investigator: Khaled Tolba Younes, Lecturer, Assiut University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Paramasivan A, Lopez-Olivo MA, Foong TW, et al. Intrathecal dexmedetomidine and postoperative pain: a systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020;24(7):1215-1227
- Verghese T, Dixit N, John L, et al. Effect of intravenous dexmedetomidine on duration of spinal anaesthesia with hyperbaric bupivacaine - A comparative study. Indian J Clin Anaesth. 2019;6(1):97-101.
- Senapati LK, Samanta P. Effect of intravenous versus intrathecal dexmedetomidine on characteristics of hyperbaric bupivacaine spinal anesthesia in lower limb surgery. Asian J Pharm Clin Res. 2018;11:427-430.
- Santpur MU, Kahalekar GM, Saraf N, et al. Effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: a prospective randomized control study. Anesth Essays Res. 2016;10(3):497-501.
- ] Niu XY, Ding XB, Guo T, et al. Effects of intravenous and intrathecal dexmedetomidine in spinal anesthesia: a meta-analysis. CNS Neurosci Ther. 2013;19(11):897-904.
- Camann WR, Hurley RH, Gilbertson LI, et al. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991;38(6):728-732.
- ] Chatrath V, Attri JP, Bala A, et al. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015;9(3):326.
Publications
None provided.- epidural additives in labor