Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

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

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.

Study Overview

• Status: Completed
• Conditions: Epidural Analgesia; Dexmedetomidine; Fentanyl; Painless Labor; Levobupivacaine
• Intervention / Treatment: Drug: levobupivacaine; Drug: Dexmedetomidine; Drug: Fentanyl

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Gharbiya
    • Tanta, Gharbiya, Egypt, 31527
      • Tanta University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group C (Control group); pidural analgesia with levobupivacaine alone	Drug: levobupivacaine; The patients will receive 15 ml of 0.125% levobupivacaine.
Experimental: Group D (Dexmedetomidine group); Epidural analgesia with levobupivacaine and dexmedetomidine	Drug: levobupivacaine; The patients will receive 15 ml of 0.125% levobupivacaine.; Drug: Dexmedetomidine; The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.
Experimental: Group F (Fentanyl group); Epidural analgesia with levobupivacaine and fentanyl	Drug: levobupivacaine; The patients will receive 15 ml of 0.125% levobupivacaine.; Drug: Fentanyl; The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Complications of drugs of epidural technique	Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)	24 hours after epidural injection

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): March 28, 2022
• Last Update Submitted That Met QC Criteria: March 10, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Dexmedetomidine; Levobupivacaine
• Other Study ID Numbers: 33447/10/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No