Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Phase 4

Completed

• Conditions: Dexmedetomidine; Levobupivacaine; Painless Labor; Epidural Analgesia; Fentanyl
• Interventions: Drug: levobupivacaine; Drug: Dexmedetomidine; Drug: Fentanyl

• Registration Number: NCT04397406
• Lead Sponsor: Tanta University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Study Start: 2020-07-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C (Control group)	levobupivacaine	pidural analgesia with levobupivacaine alone
Group D (Dexmedetomidine group)	Dexmedetomidine	Epidural analgesia with levobupivacaine and dexmedetomidine
Group D (Dexmedetomidine group)	levobupivacaine	Epidural analgesia with levobupivacaine and dexmedetomidine
Group F (Fentanyl group)	levobupivacaine	Epidural analgesia with levobupivacaine and fentanyl
Group F (Fentanyl group)	Fentanyl	Epidural analgesia with levobupivacaine and fentanyl

Primary Outcome Measures

Name	Time	Method
Duration of maternal analgesia	24 hours after epidural injection	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).

Secondary Outcome Measures

Name	Time	Method
Onset of maternal analgesia.	One hour after epidural injection	The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) \<3.
Complications of drugs of epidural technique	24 hours after epidural injection	Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)

Trial Locations

Locations (1)

Tanta University Hospitals; 🇪🇬 Tanta, Gharbiya, Egypt