Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension

Dr. Soliman Fakeeh Hospital

Status: Completed

Conditions: Cesarean Section

Treatments: Drug: fentanyl; Drug: Hyperbaric bupivacaine; Drug: hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02577432

01/REC/2013

Details and patient eligibility

About

Background: Poor spinal anaesthesia block is common and is difficult to manage; so a technique to minimize its incidence is advisable. Hypotension is the commonest problem with spinal anesthesia. Multiple trials to prevent or combat hypotension using positional changes, fluid therapy and the use of vasopressors were tried. However, the drug choice and mode of administration as either bolus or infusion is still a matter of debate.

Objectives: To compare the outcome of spinal injection of hyperbaric bupivacaine and fentanyl separately to standard injection of mixed fentanyl with hyperbaric bupivacaine.

Design: A randomized, controlled clinical trial.

Setting: Single medical center from 5/2013 to 10/2014.

Patients & Methods: 124 parturient scheduled for elective cesarean section (CS) were randomly allocated into two groups, each 62 parturient: Group M received spinal anesthesia using 10 mg bupivacaine 0.5% premixed with 25 µg fentanyl in the same syringe and Group S received 25 µg fentanyl in one syringe and 10 mg bupivacaine 0.5% without barbotage in a second syringe. Intravenous fluid co-load with 15 ml/kg warm lactated ringer solution was started as fast drip during, and continued after spinal anesthesia.

Patients were monitored for hemodynamic parameters, time of sensory onset and height of maximum sensory block, lower limb motor blockade was scored using modified Bromage scale and the frequency of side effects.

Enrollment: 124 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Parturient at full term.
• Must be elective cesarean section.
• Must be uncomplicated pregnancy

Exclusion criteria

• Body weight <50 kg or >90 kg
• Height ˂150 cm or >170 cm.
• Pre-eclampsia.
• Any major systemic disease.
• Contraindication to regional anesthesia.
• Allergy to used medications.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups

(S) separate.

Active Comparator group

Description:

fentanyl and hyperbaric bupivacaine (sequentially)

Treatment:

Drug: fentanyl

Drug: fentanyl

Drug: Hyperbaric bupivacaine

(M) mixed

Active Comparator group

Description:

fentanyl and hyperbaric bupivacaine.(mixed)

Treatment:

Drug: fentanyl

Drug: fentanyl

Drug: hyperbaric bupivacaine