Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Dexmedetomidine Clinical Trial

Official title:

Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04397406
• Other study ID #: 33447/10/19
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: October 31, 2021

Study information

• Verified date: March 2022
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics. The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 41 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) physical status class II and III,
• Full term pregnancy.

Exclusion Criteria:

• Patient refusal to epidural analgesia,
• Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
• Cardiac diseases
• Severe pre-eclampsia,
• Breech presentations
• Antepartum hemorrhage
• Cephalopelvic disproportion
• Body mass index =40 kg/m2.

Related Conditions & MeSH terms

• Dexmedetomidine
• Epidural Analgesia
• Fentanyl
• Levobupivacaine
• Painless Labor

Intervention

Drug:
• levobupivacaine
The patients will receive 15 ml of 0.125% levobupivacaine.
• Dexmedetomidine
The patients will receive 13 ml of 0.125% levobupivacaine and 0.5µg/kg dexmedetomidine diluted in 2 ml saline.
• Fentanyl
The patients will receive 13 ml of 0.125% levobupivacaine and 25µg fentanyl diluted in 2 ml saline.

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	Gharbiya

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of maternal analgesia	Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be = 4.; The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain).	24 hours after epidural injection
Secondary	Onset of maternal analgesia.	The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) <3.	One hour after epidural injection
Secondary	Complications of drugs of epidural technique	Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)	24 hours after epidural injection