Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dexmedetomidine, fentanyl, Saline 0.9%.
- Who it may be relevant to
- Registry conditions: Vaginal Delivery, Normal Labor. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug Dexmedetomidine
5 mic dexmedetomidine will be given intrathecally added to 2.5 mg bupivacaine - Drug fentanyl
25 mic of fentanyl will be given intrathecally added to 2.5 mg bupivacaine - Drug Saline 0.9%
0.5 ml of saline 0.9% will be given intrathecally added to 2.5 mg of bupivacaine
Primary outcome measures
- the duration and onset of analgesia. [Time frame: baseline, pre intervention and after intervention for an average 6 hours]
- the change in visual analogue scale (VAS) of the labor pain. [Time frame: baseline, pre intervention and after intervention an average 6 hours]
Secondary outcome measures (5)
- maternal satisfaction assessed using a satisfaction questionnaire. [Time frame: At delivery/birth]
- change in maternal hemodynamics as blood pressure. [Time frame: baseline, pre intervention and after intervention for an average 6 hours]
- change in maternal hemodynamics as heart rate [Time frame: baseline, pre intervention and after intervention for an average 6 hours]
- change in maternal hemodynamics as respiratory rate. [Time frame: baseline, pre intervention and after intervention for an average 6 hours.]
- Apgar score at 1 and 5 minutes. [Time frame: will be recorded 1 minute after delivery and 5 minutes after delivery.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Aswan University Hospital — Aswān
Publications
- Eldemrdash AM, Elsawy TTD, Zaher ZZ, Younan JS, Ragheb AMR. Single-Shot Intrathecal Bupivacaine With Fentanyl vs. Dexmedetomidine for Labor Analgesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2026 Apr 29;2026:6685169. doi: 10.1155/anrp/6685169. eCollection 2026. PMID 42063584
Identifiers
NCT: NCT06823349 · Asw.Uni. / 926 / 5 / 24