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

Not Applicable

Completed

• Conditions: Cesarean Section
• Interventions: Drug: fentanyl; Drug: hyperbaric bupivacaine

• Registration Number: NCT02577432
• Lead Sponsor: Dr. Soliman Fakeeh Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-10
• Study First Submitted: 2015-10-10
• Study First Submitted QC: 2015-10-15
• Study First Posted: 2015-10-16
• Last Update Submitted: 2015-10-19
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
(S) separate.	hyperbaric bupivacaine	fentanyl and hyperbaric bupivacaine (sequentially)
(M) mixed	hyperbaric bupivacaine	fentanyl and hyperbaric bupivacaine.(mixed)
(S) separate.	fentanyl	fentanyl and hyperbaric bupivacaine (sequentially)
(M) mixed	fentanyl	fentanyl and hyperbaric bupivacaine.(mixed)

Primary Outcome Measures

Name	Time	Method
incidence of hypotension	intraoperative
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.	intraoperative