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

Study Overview
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Brief Summary
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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.

Official Title
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Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension

Conditions
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Cesarean Section

Intervention / Treatment
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* Drug: fentanyl
* Drug: fentanyl
* Drug: Hyperbaric bupivacaine
* Drug: hyperbaric bupivacaine


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (S) separate.<br>fentanyl and hyperbaric bupivacaine (sequentially) | Drug: fentanyl<br>* Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.<br>Drug: Hyperbaric bupivacaine<br>* Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.<br>|
| Active Comparator: (M) mixed<br>fentanyl and hyperbaric bupivacaine.(mixed) | Drug: fentanyl<br>* Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.<br>Drug: hyperbaric bupivacaine<br>* Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System. |  | intraoperative | 
| incidence of hypotension |  | intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spinal anesthesia