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

Phase 4

Recruiting

• Conditions: Vaginal Delivery; Normal Labor
• Interventions: Drug: Dexmedetomidine; Drug: fentanyl; Drug: Saline 0.9%

• Registration Number: NCT06823349
• Lead Sponsor: Jehan George Sadek

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.

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 and the patient will be excluded.

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. Maternal satisfaction questionnaire will be done after delivery to assess maternal satisfaction.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study Start: 2025-02-01
• Study First Submitted QC: 2025-02-10
• Study First Posted: 2025-02-12
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	the investigators give 5 mic of dexmedetomidine (0.5 ml) added to 25 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally
fentanyl	fentanyl	the investigators give 25 mic of fentanyl (0.5 ml) added to 25 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally
Bupivacaine only	Saline 0.9%	the investigators give 0.5 ml saline 0.9% added to 25 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Primary Outcome Measures

Name	Time	Method
the duration and onset of analgesia.	baseline, pre intervention and after intervention for an average 6 hours	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).
the change in visual analogue scale (VAS) of the labor pain.	baseline, pre intervention and after intervention an average 6 hours	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

Secondary Outcome Measures

Name	Time	Method
maternal satisfaction assessed using a satisfaction questionnaire.	At delivery/birth	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.
change in maternal hemodynamics as blood pressure.	baseline, pre intervention and after intervention for an average 6 hours	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).
change in maternal hemodynamics as heart rate	baseline, pre intervention and after intervention for an average 6 hours	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).
change in maternal hemodynamics as respiratory rate.	baseline, pre intervention and after intervention for an average 6 hours.	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.
Apgar score at 1 and 5 minutes.	will be recorded 1 minute after delivery and 5 minutes after delivery.	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.

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt