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

Cesarean Section Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577432
• Other study ID #: 01/REC/2013
• Status: Completed
• Phase: N/A
• First received: October 10, 2015
• Last updated: October 19, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2015
• Source: Dr. Soliman Fakeeh Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Dr. Soliman Fakeeh Hospital Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension

Intervention

Drug:
• fentanyl
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
• fentanyl
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
• Hyperbaric bupivacaine
Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
• hyperbaric bupivacaine
Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Soliman Fakeeh Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of parturients needed more analgesics (unsatisfactory block) using Ochsner Health System.		intraoperative	Yes
Primary	incidence of hypotension		intraoperative	Yes