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

Sponsor

Dr. Soliman Fakeeh Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02577432

Collaborator

(none)

124

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Drug: fentanyl Drug: fentanyl Drug: Hyperbaric bupivacaine Drug: hyperbaric bupivacaine	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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 Start Date :

May 1, 2013

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: (S) separate.

fentanyl and hyperbaric bupivacaine (sequentially)

Drug: fentanyl

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

Drug: Hyperbaric bupivacaine

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

Active Comparator: (M) mixed

fentanyl and hyperbaric bupivacaine.(mixed)

Drug: fentanyl

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

Drug: hyperbaric bupivacaine

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

Outcome Measures

Primary Outcome Measures

Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System. [intraoperative]
incidence of hypotension [intraoperative]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dr. Soliman Fakeeh Hospital

Investigators

Principal Investigator: Amr A Keera, MD, Dr. Benha Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Amr Aly Ismail Keera, Assistant professor, Dr. Soliman Fakeeh Hospital

ClinicalTrials.gov Identifier:

NCT02577432

Other Study ID Numbers:

01/REC/2013

First Posted:

Oct 16, 2015

Last Update Posted:

Oct 20, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Dr. Amr Aly Ismail Keera, Assistant professor, Dr. Soliman Fakeeh Hospital

spinal anesthesia

Additional relevant MeSH terms:

Hypotension

Fentanyl

Bupivacaine

Study Results

No Results Posted as of Oct 20, 2015