Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine at Different Rates; Does it Make Difference?

56 Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate (normal sequential) NS or a rapid intrathecal injection of fentanyl followed by slow injection of hyperbaric bupivacaine (rapid sequential) RS. Time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain, incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications and failed block were recorded.

Study Overview

• Status: Completed
• Conditions: Elective Caesarean Section
• Intervention / Treatment: Procedure: sequential intrathecal injection; Drug: hyperbaric bupivacaine; Drug: fentanyl

Detailed Description

56 ASA physical status I, II Parturients, aged 18-40 year, undergoing elective CS were randomly assigned to receive sequential intrathecal injection of fentanyl and hyperbaric bupivacaine at the same rate through a 5ml syringe each (NS (normal sequential), n 28) or a rapid intrathecal injection of fentanyl through an insuline syringe followed by slow injection of hyperbaric bupivacaine through a 5ml syringe RS (rapid sequential), n 28). Onset of sensory block (T6 level), highest level of sensory block, time of first rescue analgesia, Dose of rescue analgesics, degree of postoperative pain by VAS 6H postoperative, Onset of motor block (Bromage scale0>3), duration of motor block (return to Bromage 0), incidence of hypotension, hypotension duration, ephedrine dose, spinal anaesthesia related complications as nausea, vomiting, pruritis, shivering and failed block were recorded.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA I, II
• Parturients aged from 18-40 years old
• scheduled for elective CS

Exclusion Criteria:

• parturients with complicated pregnancy as (preeclampsia, pregnancy induced HTN, gestational Diabetes, abnormal placenta (placenta previa), multiple gestation),
• BMI greater than 35 or less than 22,
• major systemic disease (cardiac, renal, liver),
• need for emergency CS,
• having allergy to drugs used in the study,
• having contraindication for spinal anaesthesia or
• refused regional anaesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: sequential intrathecal injection of fentanyl and bupivacaine; intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV,once drug: hyperbaric bupivacaine 0.5%10 mg IV,once both syringes were injected slowly sequentially	Procedure: sequential intrathecal injection; intrathecal injection of fentanyl and hyperbaric bupivacaine; Other Names: sequential spinal anaesthesia; Drug: hyperbaric bupivacaine; intrathecal injection of intrathecal bupivacaine; Other Names: heavy marcaine; Drug: fentanyl; intrathecal injection of fentanyl; Other Names: opioid
EXPERIMENTAL: rapid sequential intrathecal injection of fentanyl and bupiva; intrathecal injection drug: fentanyl 25 μg (0.5 ml), IV, injected rapidly and mixed by CSF, once drug: hyperbaric bupivacaine 0.5%10 mg IV injected slowly once.	Procedure: sequential intrathecal injection; intrathecal injection of fentanyl and hyperbaric bupivacaine; Other Names: sequential spinal anaesthesia; Drug: hyperbaric bupivacaine; intrathecal injection of intrathecal bupivacaine; Other Names: heavy marcaine; Drug: fentanyl; intrathecal injection of fentanyl; Other Names: opioid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of postoperative analgesia	technique provides prolonged post operative analgesia	2-5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of hypotension	note if hypotension occurs	30 minutes

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: December 24, 2017
• First Submitted That Met QC Criteria: January 27, 2018
• First Posted (ACTUAL): January 30, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2018
• Last Update Submitted That Met QC Criteria: January 27, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: R47

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No