Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor

NCT06823349 | Recruiting Phase 4 DMC

• 1 other identifier: Asw.Uni. / 926 / 5 / 24
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

the goal of this randomized control trial is to compare the effect of adding fentanyl v.s dexmedetomidine to bupivacaine in single shot spinal analgesia in achievement of analgesia by decreasing visual analogue scale, onset and increasing duration of analgesia in normal labor.

Conditions

Vaginal Delivery; Normal Labor

Keywords

painless normal labor; Single shot spinal analgesia in vaginal delivery

Outcome Measures

Primary Outcomes (2)

• the duration and onset of analgesia.

  onset of analgesia will be determined as time taken (in minutes) from the administration of intrathecal drug to the patient reporting effective pain relief (e.g. vas score reduction) duration of analgesia will be determined as time ( in minutes) from onset of analgesia until the patient require additional analgesia or reports significant pain (e.g. VAS score above a threshold).

  baseline, pre intervention and after intervention for an average 6 hours

• the change in visual analogue scale (VAS) of the labor pain.

  change in visual analogue score (VAS) as it is score for measuring pain intensity consisting of 0 to 10 cm line with endpoints labeled as 0 is no pain and 10 is the worst pain and will be evaluated every 5 min for the first 30 min, followed by every 20 min for 3 hours then every 30 min for next 3 hours

  baseline, pre intervention and after intervention an average 6 hours

Secondary Outcomes (5)

• maternal satisfaction assessed using a satisfaction questionnaire.

  At delivery/birth

• change in maternal hemodynamics as blood pressure.

  baseline, pre intervention and after intervention for an average 6 hours

• change in maternal hemodynamics as heart rate

  baseline, pre intervention and after intervention for an average 6 hours

• change in maternal hemodynamics as respiratory rate.

  baseline, pre intervention and after intervention for an average 6 hours.

• Apgar score at 1 and 5 minutes.

  will be recorded 1 minute after delivery and 5 minutes after delivery.

Study Arms (3)

Dexmedetomidine

ACTIVE COMPARATOR

the investigators give 5 mic of dexmedetomidine (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Drug: Dexmedetomidine

fentanyl

ACTIVE COMPARATOR

the investigators give 25 mic of fentanyl (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Drug: fentanyl

Bupivacaine only

PLACEBO COMPARATOR

the investigators give 0.5 ml saline 0.9% added to 2.5 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Drug: Saline 0.9%

Interventions

Dexmedetomidine DRUG

5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine

Dexmedetomidine

fentanyl DRUG

25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine

fentanyl

Saline 0.9% DRUG

0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine

Bupivacaine only

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II.
• Uncomplicated pregnancy.
• At term \& singleton fetus.
• Cervical dilatation \> 5cm
• Cephalic presentations

You may not qualify if:

• Patient refusal.
• Bleeding disorders and patients on anticoagulant drugs.
• Infection at site of injection.
• Spine deformity.
• Allergy to any of study medications.

Sponsors & Collaborators

• Jehan George Sadek: lead

Study Sites (1)

Aswan University Hospital

Aswān, Egypt

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Jehan G Younan, resident doctor.

CONTACT

+20 01222333194; jehan.younan1995@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident doctor at anesthesia, surgical intensive care unit and pain management department at Aswan University hospital.

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 12, 2025
• Study Start: February 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)