Spinal Analgesia in Labour Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-24

Study Completion Date

2026-03-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Analgesic Effect of Dexmedetomidine Versus Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

NCT03463083

Dexmedetomidine VS Fentanyl as Adjuvants to Epidural Bupivacaine in Patients Undergoing Lumbar Spine Surgeries

COMPLETED NA

DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

NCT05840328

Painless Vainal Labour

UNKNOWN PHASE4

Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

NCT03438240

Anesthesia

COMPLETED PHASE4

Analgesic Additives to Epidural Bupivacaine in Normal Labor

NCT05746351

Labor Pain

UNKNOWN NA

Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries

NCT07023991

Post-operative Pain

ENROLLING_BY_INVITATION PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labour Analgesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Masking Description

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

injecting dexmedetomidine

Intervention Type DRUG

injecting dexmedetomidine intrathecally during labour pain

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.

Group Type ACTIVE_COMPARATOR

injecting mixture of bupivacaine fentanyl

Intervention Type DRUG

injecting mixture of bupivacaine fentanyl intrathecally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

injecting dexmedetomidine

injecting dexmedetomidine intrathecally during labour pain

Intervention Type DRUG

injecting mixture of bupivacaine fentanyl

injecting mixture of bupivacaine fentanyl intrathecally

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes