Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
Primary Purpose
Cesarean Section
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fentanyl
fentanyl
Hyperbaric bupivacaine
hyperbaric bupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Cesarean Section focused on measuring spinal anesthesia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
(S) separate.
(M) mixed
Arm Description
fentanyl and hyperbaric bupivacaine (sequentially)
fentanyl and hyperbaric bupivacaine.(mixed)
Outcomes
Primary Outcome Measures
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
incidence of hypotension
Secondary Outcome Measures
Full Information
NCT ID
NCT02577432
First Posted
October 10, 2015
Last Updated
October 19, 2015
Sponsor
Dr. Soliman Fakeeh Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02577432
Brief Title
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
Official Title
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Controlled Randomized Study of a Simple Way to Achieve More Satisfactory Block and Less Hypotension
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Soliman Fakeeh Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Section
Keywords
spinal anesthesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
(S) separate.
Arm Type
Active Comparator
Arm Description
fentanyl and hyperbaric bupivacaine (sequentially)
Arm Title
(M) mixed
Arm Type
Active Comparator
Arm Description
fentanyl and hyperbaric bupivacaine.(mixed)
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
Intervention Type
Drug
Intervention Name(s)
fentanyl
Intervention Description
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
Intervention Type
Drug
Intervention Name(s)
Hyperbaric bupivacaine
Intervention Description
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
Intervention Type
Drug
Intervention Name(s)
hyperbaric bupivacaine
Intervention Description
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
Primary Outcome Measure Information:
Title
Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.
Time Frame
intraoperative
Title
incidence of hypotension
Time Frame
intraoperative
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr A Keera, MD
Organizational Affiliation
Dr. Benha Faculty of Medicine
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Two Syringe Spinal Anesthesia Technique for Cesarean Section: A Simple Way to Achieve More Satisfactory Block and Less Hypotension
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