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

NCT02577432 | Completed DMC

• 1 other identifier: 01/REC/2013
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cesarean Section

Keywords

spinal anesthesia

Outcome Measures

Primary Outcomes (2)

• Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.

  intraoperative

• incidence of hypotension

  intraoperative

Study Arms (2)

(S) separate.

ACTIVE COMPARATOR

fentanyl and hyperbaric bupivacaine (sequentially)

Drug: fentanyl; Drug: Hyperbaric bupivacaine

(M) mixed

ACTIVE COMPARATOR

fentanyl and hyperbaric bupivacaine.(mixed)

Drug: fentanyl; Drug: hyperbaric bupivacaine

Interventions

fentanyl DRUG

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

(S) separate.

hyperbaric bupivacaine DRUG

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

(S) separate.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Soliman Fakeeh Hospital: lead

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amr A Keera, MD

  Dr. Benha Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 10, 2015
• First Posted: October 16, 2015
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 20, 2015

Record last verified: 2015-10