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

Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: Single Shot Intrathecal Bupivacaine With Fentanyl Versus Bupivacaine With Dexmedetomidine in Normal Labor, Randomized Control Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Delivery; Normal Labor
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: fentanyl; Drug: Saline 0.9%

Detailed Description

on arrival to the operating room, the demographic and baseline data will be collected, which include sections about age, height, weight, primigravida or multigravida, cervical dilation at the time of performing labor analgesia, fetus presentation, presence of rupture of membrane, baseline pain scores will be assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain) before SSSA. Intravenous access will be achieved in all patients loading will be undertaken using 500 ml Ringer's solution, baseline values of pulse rate (PR), respiratory rate (RR), hemoglobin oxygen saturation (SpO2), and arterial blood pressure (ABP) will be recorded. SSSA will be performed with the parturient in the sitting position under complete aseptic precautions at the L3-L4 level using a 25-gauge spinal needles. The correct positioning of the needle tip in the intrathecal space will be confirmed by the observation of a free flow of cerebrospinal fluid, and then the prefilled study drug will be injected intrathecally which is 2.5 mg bupivacaine plus 25 mic fentanyl or 5 mic dexmedetomidine or 0.5 ml saline according to different groups.

parturient will then turn to the supine position, and a wedge will be placed under the right buttocks to prevent aortocaval compression. VAS 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. If VAS 8 or more the instigators will give the patient 50 mg intramuscular pethidine.

Maternal blood pressure, heart rate, respiratory rate, and oxygen saturation will be measured and recorded noninvasively every 5 min for the first half hour, followed by every 20 min for 3 hours, then every 1 h for next 3 hours. the investigators will give 5 mg ephedrine if there is hypotension ( decrease in ABP more than 25% of the baseline ABP) and .5 mg atropine if there is bradycardia (HR less than 50 beats per minute). Side effects such as hypotension, nausea, vomiting, bradycardia, shivering, pruritus, and tachycardia will be recorded. The first- and fifth-minute Apgar scores will also be recorded. The onset, duration of analgesia, and obstetric and neonatal outcomes will be compared.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jehan G Younan, resident doctor.; Phone Number: +20 01222333194; Email: jehan.younan1995@gmail.com

Study Locations

• Egypt
  • Aswan, Egypt
    • Recruiting
    • Aswan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dexmedetomidine; 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; 5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine
Active Comparator: fentanyl; 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; 25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine
Placebo Comparator: Bupivacaine only; 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%; 0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal satisfaction assessed using a satisfaction questionnaire.	it is a questionnaire that has been made according to 5 scale questionnaire as 1-is very dissatisfied 2- dissatisfied 3- neutral 4- satisfied 5- very satisfied.	At delivery/birth
change in maternal hemodynamics as blood pressure.	Maternal blood pressure will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours. a hypotension will be defined as ( decrease in mean ABP more than 25% of the baseline mean ABP).	baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as heart rate	heart rate will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours. a bradycardia will be defined as (HR less than 50 beats per minute).	baseline, pre intervention and after intervention for an average 6 hours
change in maternal hemodynamics as respiratory rate.	respiratory rate will be measured and recorded noninvasively every 5 minutes for the first half hour, followed by every 20 minutes for 3 hours, then every 1 hour for next 3 hours. Bradypnea will be defined as respiratory rate below 12 cycle / minute.	baseline, pre intervention and after intervention for an average 6 hours.
Apgar score at 1 and 5 minutes.	score range 0-10, assessing skin color, heart rate, reflexes, muscle tone, respiratory effort and rate. total score range from 0 to 10. a score of 7 or above indicate good health, while a lower score may require medical attention.	will be recorded 1 minute after delivery and 5 minutes after delivery.

Collaborators and Investigators

• Sponsor: Jehan George Sadek

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Actual): June 30, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 12, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: painless normal labor; Single shot spinal analgesia in vaginal delivery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Analgesics, Opioid; Narcotics; Neurotransmitter Agents; Adjuvants, Anesthesia; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine; Fentanyl
• Other Study ID Numbers: Asw.Uni. / 926 / 5 / 24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No