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Not yet recruiting NCT07332130

Spinal Analgesia in Labour Pain

Phase I Interventional Labour Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: injecting dexmedetomidine, injecting mixture of bupivacaine fentanyl.
Who it may be relevant to
Registry conditions: Labour Analgesia. Basic parameters: 18 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Drug injecting dexmedetomidine
    injecting dexmedetomidine intrathecally during labour pain
  • Drug injecting mixture of bupivacaine fentanyl
    injecting mixture of bupivacaine fentanyl intrathecally

Primary outcome measures

  • changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0 [Time frame: baseline]
  • duration of sensory blockade [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Minya — Minya

Identifiers

NCT: NCT07332130 · 1337/11/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗