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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04397406

Enrollment

Registered

2020-05-21

Start date

2020-07-01

Completion date

2021-10-31

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine, Epidural Analgesia, Fentanyl, Levobupivacaine, Painless Labor

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.

Interventions

DRUGlevobupivacaine

The patients will receive 15 ml of 0.125% levobupivacaine.

DRUGDexmedetomidine

The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.

DRUGFentanyl

The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients. Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl

Eligibility

Sex/Gender

ALL

Age

21 Years to 41 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026