Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

• Sponsor: Tanta University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04397406
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 16
• Patients Per Site Per Month: 5.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epidural Analgesia; Painless Labor; Dexmedetomidine; Fentanyl; Levobupivacaine	Drug: levobupivacaine; Drug: Dexmedetomidine; Drug: Fentanyl	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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 fentanylPatients 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
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study
• Actual Study Start Date: Jul 1, 2020
• Actual Primary Completion Date: Oct 31, 2021
• Actual Study Completion Date: Oct 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Complications of drugs of epidural technique [24 hours after epidural injection]

   Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 41 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University Hospitals	Tanta	Gharbiya	Egypt	31527

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hend Mahmoud Moneeb El-shazly, Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
• ClinicalTrials.gov Identifier: NCT04397406
• Other Study ID Numbers: 33447/10/19
• First Posted: May 21, 2020
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Fentanyl; Dexmedetomidine; Levobupivacaine

Study Results

No Results Posted as of Mar 28, 2022