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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
90
5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine
25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine
0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
Aswan University Hospital
Aswān, Egypt
RECRUITINGthe 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 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
Time frame: baseline, pre intervention and after intervention an average 6 hours
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/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).
Time frame: 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).
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Time frame: 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.
Time frame: 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.
Time frame: will be recorded 1 minute after delivery and 5 minutes after delivery.