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Spinal Analgesia in Labour Pain

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

Status
Not yet recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07332130
Enrollment
100
Registered
2026-01-12
Start date
2025-12-24
Completion date
2026-03-02
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Analgesia

Brief summary

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

Detailed description

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

Interventions

DRUGinjecting dexmedetomidine

injecting dexmedetomidine intrathecally during labour pain

DRUGinjecting mixture of bupivacaine fentanyl

injecting mixture of bupivacaine fentanyl intrathecally

Sponsors

Minia University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Masking Description

Intervention model description

effect of adding dexmetomidine to bupivcain fentanyl mixture in spinal analgesia for normal labour

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0baselineevaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )
duration of sensory blockade5 minutes after injection of analgesic agents till normal delivery donechange in numeric pain intensity score ( NPIS )
changes in numeric pain intensity score ( NPIS )5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agentsScores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain

Countries

Egypt

Contacts

Primary ContactMohamed Ragab, Master
mohamedragab2209@gmail.com086-01001737436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026