Spinal Analgesia in Labour Pain

Minia University Hospital

Status and phase: Not yet enrolling; Phase 1

Conditions: Labour Analgesia

Treatments: Drug: injecting dexmedetomidine; Drug: injecting mixture of bupivacaine fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT07332130

1337/11/2024

Details and patient eligibility

About

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

Full description

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

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

DEX

Active Comparator group

Description:

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.

Treatment:

Drug: injecting dexmedetomidine

CONTROLLED

Active Comparator group

Description:

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.

Treatment:

Drug: injecting mixture of bupivacaine fentanyl