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

NCT02577432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2015-10-20

No results posted yet for this study

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.

Conditions

  • Cesarean Section

Interventions

DRUG

fentanyl

Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.

DRUG

fentanyl

Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.

DRUG

Hyperbaric bupivacaine

Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.

DRUG

hyperbaric bupivacaine

Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.

Sponsors & Collaborators

  • Dr. Soliman Fakeeh Hospital

    lead OTHER

Principal Investigators

  • Amr A Keera, MD · Dr. Benha Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-10-31
Completion
2014-10-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02577432 on ClinicalTrials.gov