Analgesic Additives to Epidural Bupivacaine in Normal Labor

NCT05746351 | Unknown

• 1 other identifier: epidural additives in labor
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.

Conditions

Labor Pain

Keywords

epidural anathesia; normal labor

Outcome Measures

Primary Outcomes (1)

• VAS score for pain

  changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.

  before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.

Study Arms (3)

epidural Bupivacaine with Dexmedetomidine in normal labor

ACTIVE COMPARATOR

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml

Drug: Dexmedetomidine

epidural Bupivacaine with fentanyl in normal labor

ACTIVE COMPARATOR

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.

Drug: fentanyl

epidural Bupivacaine with Nalbuphine in normal labor

ACTIVE COMPARATOR

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.

Drug: Nalbuphine

Interventions

Dexmedetomidine DRUG

a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor

Also known as: precedex

epidural Bupivacaine with Dexmedetomidine in normal labor

fentanyl DRUG

a group will receive epidural Bupivacaine with fentanyl in normal labor

Also known as: Durogesic

epidural Bupivacaine with fentanyl in normal labor

Nalbuphine DRUG

a group will receive epidural Bupivacaine with Nalbuphine in normal labor

Also known as: Nalufin

epidural Bupivacaine with Nalbuphine in normal labor

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \>/= 18 years of age
• American Society of Anesthesiologists (ASA) Physical Status 2 or 3
• Full term pregnancy (\>37 gestational weeks)
• Planning vaginal delivery
• Planning epidural labor analgesia
• Vertex presentation

You may not qualify if:

• Patient refusal to epidural analgesia,
• Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
• Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
• hemodynamic instability, severe aortic or mitral stenosis)
• Severe pre-eclampsia,
• Breech presentations
• Antepartum hemorrhage
• Cephalopelvic disproportion
• Body mass index ≥40 kg/m2.
• Uncontrolled systemic comorbidities \[i.e., diabetes, hepatic, renal or cardiac\]
• Known or suspected fetal abnormalities
• Inability to communicate or participate in study procedures

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Paramasivan A, Lopez-Olivo MA, Foong TW, et al. Intrathecal dexmedetomidine and postoperative pain: a systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020;24(7):1215-1227
• Senapati LK, Samanta P. Effect of intravenous versus intrathecal dexmedetomidine on characteristics of hyperbaric bupivacaine spinal anesthesia in lower limb surgery. Asian J Pharm Clin Res. 2018;11:427-430.
• Santpur MU, Kahalekar GM, Saraf N, et al. Effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: a prospective randomized control study. Anesth Essays Res. 2016;10(3):497-501.
• \] Niu XY, Ding XB, Guo T, et al. Effects of intravenous and intrathecal dexmedetomidine in spinal anesthesia: a meta-analysis. CNS Neurosci Ther. 2013;19(11):897-904.
• Camann WR, Hurley RH, Gilbertson LI, et al. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991;38(6):728-732.
• \] Chatrath V, Attri JP, Bala A, et al. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015;9(3):326.

MeSH Terms

Conditions

Labor Pain

Interventions

Dexmedetomidine; Fentanyl; Nalbuphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Zein EA Zareh Hassan, professor

  Assiut University

  STUDY CHAIR

• Elwani Eldramy Elsenosi, professor

  Assiut University

  STUDY DIRECTOR

• Khaled Tolba Younes, Lecturer

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abanob Fathy Zareef, MBBS

CONTACT

01010424707; bebofathy47@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Model Details: The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share