Comparative Analysis of Analgesic Efficacy: by Single Shot Intrathecal Analgesia (SSSA) in Normal Labor

Jehan George Sadek

Status and phase: Enrolling; Phase 4

Conditions: Normal Labor; Vaginal Delivery

Treatments: Drug: fentanyl; Drug: Saline 0.9%; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06823349

Asw.Uni. / 926 / 5 / 24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 3 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

the investigators give 5 mic of dexmedetomidine (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Treatment:

Drug: Dexmedetomidine

fentanyl

Active Comparator group

Description:

the investigators give 25 mic of fentanyl (0.5 ml) added to 2.5 mg bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Treatment:

Drug: fentanyl

Bupivacaine only

Placebo Comparator group

Description:

the investigators give 0.5 ml saline 0.9% added to 2.5 mg of bupivacaine (0.5 ml) as total volume 1 ml intrathecally

Treatment:

Drug: Saline 0.9%