Spinal Analgesia in Labour Pain

December 31, 2025 updated by: Mohamed Ragab Mohamed, Minia University Hospital

Effect of Adding Dexmedetomidine to Bupivacain _fentanyl Mixture in Spinal Analgesia for Normal Labour

To evaluate the efficacy and safety of dexmedetomidine as an adjuvant to bupivacain and fentanyl in spinal Analgesia to decreases pain during normal labour

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Effect of adding dexmedetomidine to bupivacain fentanyl mixture in spinal analgesia for normal labour

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Age of patint is between 18 and 40 years. gestational age of fetus is more than 37 weeks. singleton viable fetus and cephalic presentation. spontaneous labor with cervix dilation more than 5cm.

Exclusion Criteria:

Drug allergy. Blood Disease. Infection at site of injection. patient takes anticoagulants. patient has pre-eclampsia ,cardiac disease (NYHA III-IV) or diabetes mellitus type I prior to the pregnancy patients refuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DEX
Participants receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with dexmedetomidine 2.5 µg and fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions.
Drug: injecting dexmedetomidine
injecting dexmedetomidine intrathecally during labour pain
Active Comparator: CONTROLLED
Participants will receive intrathecaliy hyperbaric bupivacaine 2.5 mg (0.5 mL) combined with fentanyl 25 µg, diluted to a total volume of 2.5 mL. The solution will be administered as a single spinal injection under aseptic conditions.
Drug: injecting mixture of bupivacaine fentanyl
injecting mixture of bupivacaine fentanyl intrathecally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0
Time Frame: baseline
evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )
baseline
duration of sensory blockade
Time Frame: 5 minutes after injection of analgesic agents till normal delivery done
change in numeric pain intensity score ( NPIS )
5 minutes after injection of analgesic agents till normal delivery done
changes in numeric pain intensity score ( NPIS )
Time Frame: 5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents
Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain
5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University Hospital

Investigators

  • Principal Investigator: Mohamed Ragab, master, Minia University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 24, 2025

Primary Completion (Estimated)

January 10, 2026

Study Completion (Estimated)

March 2, 2026

Study Registration Dates

First Submitted

December 2, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Estimated)

January 12, 2026

Study Record Updates

Last Update Posted (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 1337/11/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD,

IPD Sharing Time Frame

december 2025 - december 2026

IPD Sharing Access Criteria

labour analgesia

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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