Normal Labor, Vaginal Delivery
Conditions
Keywords
painless normal labor, Single shot spinal analgesia in vaginal delivery
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. 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.
Interventions
DRUGDexmedetomidine
5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine
DRUGfentanyl
25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine
DRUGSaline 0.9%
0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
Sponsors
Jehan George Sadek
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| 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. |
| 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). |
Countries
Egypt
Contacts
Primary ContactJehan G Younan, resident doctor.
Outcome results
None listed