Spinal Analgesia in Labour Pain

NCT07332130 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: 1337/11/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Labour Analgesia

Outcome Measures

Primary Outcomes (3)

• changes in numeric pain intensity score ( NPSI) maximum 10 minimum 0

  evaluate the safety and effecacy of dexmetomidine for labour pain by numeric pain intensity score maximum 10 ( sever pain ), minimum 0 ( no pain )

  baseline

• duration of sensory blockade

  change in numeric pain intensity score ( NPIS )

  5 minutes after injection of analgesic agents till normal delivery done

• changes in numeric pain intensity score ( NPIS )

  Scores range from 0-10 points, maximum ( 10 ) means sever pain, minimum ( 0 ) means no pain

  5 minutes, 10 minutes, 15 minutes, 30 minutes and 45 minintes after injection of analgesic agents

Study Arms (2)

DEX

ACTIVE COMPARATOR

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.

Drug: injecting dexmedetomidine

CONTROLLED

ACTIVE COMPARATOR

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.

Drug: injecting mixture of bupivacaine fentanyl

Interventions

injecting dexmedetomidine DRUG

injecting dexmedetomidine intrathecally during labour pain

DEX

injecting mixture of bupivacaine fentanyl DRUG

injecting mixture of bupivacaine fentanyl intrathecally

CONTROLLED

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Minia University Hospital: lead

Study Sites (1)

Minya

Minya, 61915, Egypt

Location

Study Officials

• Mohamed Ragab, master

  Minia University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Ragab, Master

CONTACT

086-01001737436; mohamedragab2209@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking Description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: residant

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

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 12, 2026
• Study Start: December 24, 2025
• Primary Completion: January 10, 2026
• Study Completion: March 2, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: december 2025 - december 2026
• Access Criteria: labour analgesia

Locations

EG (1)