Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorJehan George Sadek
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
ASA I-II.
Uncomplicated pregnancy.
At term & singleton fetus.
Cervical dilatation > 5cm
Disqualifiers
Patient refusal.
Bleeding disorders and patients on anticoagulant drugs.
Infection at site of injection.
Spine deformity.
Trial design
Design model
Parallel
Treatments tested in this trial
Dexmedetomidine
Drug5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine
fentanyl
Drug25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine
Saline 0.9%
Drug0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: DexmedetomidineActive comparator 1 intervention
Group B: fentanylActive comparator 1 intervention
Group C: Bupivacaine onlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
baseline, pre intervention and after intervention for an average 6 hours2
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
Time frame
baseline, pre intervention and after intervention an average 6 hoursSecondary outcomes
1
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.
Time frame
At delivery/birth2
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).
Time frame
baseline, pre intervention and after intervention for an average 6 hours3
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).
Time frame
baseline, pre intervention and after intervention for an average 6 hours4
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.
Time frame
baseline, pre intervention and after intervention for an average 6 hours.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jehan George Sadek
Lead sponsor
Aswan University Hospital
Sponsor institution
Source ClinicalTrials.gov