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NCT Number: NCT07332130

Spinal Analgesia in Labour Pain

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

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Key information

Conditions

Labour Analgesia

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injecting dexmedetomidine

Drug

injecting dexmedetomidine intrathecally during labour pain

injecting mixture of bupivacaine fentanyl

Drug

injecting mixture of bupivacaine fentanyl intrathecally

Primary outcomes

  1. 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 )

  2. duration of sensory blockade

    Time frame: 5 minutes after injection of analgesic agents till normal delivery done

    change in numeric pain intensity score ( NPIS )

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Ragab, Master

CONTACT

[email protected]

086-01001737436

Sponsors and collaborators

Lead sponsor

Minia University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 12, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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