Dexmedetomidine as an Adjuvant During Dural Puncture Epidural

The Effect of Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine for Parturients Having Dural Puncture Epidural Technique to Elaborate Labor Pain

The study aimed to determine the effects of using varied doses of DEX on the concentration of bupivacaine injected for epidural labor analgesia, and to assess the benefits of the dural puncture epidural.

Study Overview

• Status: Not yet recruiting
• Conditions: Total Dose of Bupivacaine Administered During Labor
• Intervention / Treatment: Device: Epidural Catheter with bupivacaine; Device: Epidural with dural puncture; Drug: Dexmedetomidine 0.4 added; Drug: Dexmedetomidine 0.6 added

Detailed Description

The primary efficacy point is the total dose of bupivacaine administered during labor. The secondary endpoints include the VAS pain scores, number of administered additional doses, incidence of motor block, delivery type (spontaneous vaginal or cesarean), maternal satisfaction, and complications such as hypotension, fetal bradycardia, and epidural-related maternal fever.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rabab Habeeb, MD; Phone Number: +201001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Shebeen El Kom, Egypt, 32511
    • Faculty of Medicine Menoufia University
    • Contact: Rabab Habeeb; Phone Number: 01001970973; Email: rabab_habeeb@med.menofia.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women who attend the Emergency Department in labor, with cervical dilation of 3-5 cm,
• normally presented singleton fetus, intact fetal membranes, and who are free of exclusion criteria

Exclusion Criteria:

Abnormal fetal presentation or lie, 'premature rupture of membranes, maternal fever, fetal distress, pregnancy-induced diseases

• abnormal placental position,
• ASA grade>II
• marked obesity,
• allergy or contraindications to the used drugs,
• spinal deformity or disorders 'cutaneous diseases or infection at the injection site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural group with bupivacaine CE; Epidural with plain bupivacaine DPE	Device: Epidural Catheter with bupivacaine; epidural injection of plain Bup
Active Comparator: Epidural puncture with bupivacaine; Combined epidural with epidural puncture using bupivacaine	Device: Epidural Catheter with bupivacaine; epidural injection of plain Bup; Device: Epidural with dural puncture; the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,
Active Comparator: Epidural puncture with dexmedetomidine 0.4 (Bup/DEX0.6 ); Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.4	Device: Epidural Catheter with bupivacaine; epidural injection of plain Bup; Device: Epidural with dural puncture; the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,; Drug: Dexmedetomidine 0.4 added; Dexmedetomidine 0.4 added
Active Comparator: Epidural puncture with dexmedetomidine 0.6 (Bup/DEX0.6 ); Combined epidural with epidural puncture using bupivacaine plus dexmetomedine0.6	Device: Epidural Catheter with bupivacaine; epidural injection of plain Bup; Device: Epidural with dural puncture; the dura is punctured by a 26-G spinal needle using the needle-through-needle technique, and is withdrawn after confirmation of free-flowing cerebrospinal fluid,; Drug: Dexmedetomidine 0.6 added; Dexmedetomidine 0.6 added

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total dose of bupivacaine	Total dose of bupivacaine administered	From the induction of epidural to the delivery of the fetus

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Labor pain	Labour pain measured by Visual analogue	Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Motor block	Motor block measured by bromage scsle	Before initiation of epidural ,10 ,30,45,60 min after initiation then every 1hour till the delivery of the fetus
Delivery type	Delivery type spontaneous or instrument	At time of fetus delivery
Maternal satisfaction	Satisfied or not	Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery
Complications	Any complications detected	Preoperative,2nd stage of labour, third stage of labour and immediately after delivery, 2 hours after delivery,4 hours after delivery,12 hours after delivery

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: March 16, 2026
• First Submitted That Met QC Criteria: March 27, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Epidural; Dexmedetomidine; Labour
• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections; Injections, Spinal; Injections, Epidural
• Other Study ID Numbers: 2/2026ANET2-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No