Clinical trial NCT06823349: Comparative Analysis of Analgesic Efficacy and Maternal Satisfaction: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Vaginal Delivery
Normal Labor
Keywords: painless normal labor
Single shot spinal analgesia in vaginal delivery
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 90
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: the duration and onset of analgesia.
timeFrame: baseline, pre intervention and after intervention for an average 6 hours
measure: the change in visual analogue scale (VAS) of the labor pain.
timeFrame: baseline, pre intervention and after intervention an average 6 hours
Secondary outcomes:
measure: maternal satisfaction assessed using a satisfaction questionnaire.
timeFrame: At delivery/birth
measure: change in maternal hemodynamics as blood pressure.
timeFrame: baseline, pre intervention and after intervention for an average 6 hours
measure: change in maternal hemodynamics as heart rate
timeFrame: baseline, pre intervention and after intervention for an average 6 hours
measure: change in maternal hemodynamics as respiratory rate.
timeFrame: baseline, pre intervention and after intervention for an average 6 hours.
measure: Apgar score at 1 and 5 minutes.
timeFrame: will be recorded 1 minute after delivery and 5 minutes after delivery.
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
References: