Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

NCT04397406 | Completed Phase 4

• 1 other identifier: 33447/10/19
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Epidural Analgesia; Painless Labor; Dexmedetomidine; Fentanyl; Levobupivacaine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Onset of maternal analgesia.

  One hour after epidural injection

• Complications of drugs of epidural technique

  24 hours after epidural injection

Study Arms (3)

Group C (Control group)

ACTIVE COMPARATOR

pidural analgesia with levobupivacaine alone

Drug: levobupivacaine

Group D (Dexmedetomidine group)

EXPERIMENTAL

Epidural analgesia with levobupivacaine and dexmedetomidine

Drug: levobupivacaine; Drug: Dexmedetomidine

Group F (Fentanyl group)

EXPERIMENTAL

Epidural analgesia with levobupivacaine and fentanyl

Drug: levobupivacaine; Drug: Fentanyl

Interventions

levobupivacaine DRUG

The patients will receive 15 ml of 0.125% levobupivacaine.

Group C (Control group); Group D (Dexmedetomidine group); Group F (Fentanyl group)

Dexmedetomidine DRUG

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

Group D (Dexmedetomidine group)

Fentanyl DRUG

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

Group F (Fentanyl group)

Eligibility Criteria

• Age: 21 Years - 41 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

Location

MeSH Terms

Interventions

Levobupivacaine; Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Model Details: 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

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: May 21, 2020
• Study Start: July 1, 2020
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)