Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Ain Shams University

Status: Completed

Conditions: Elective Caesarean Section

Treatments: Procedure: sequential intrathecal injection; Drug: fentanyl; Drug: hyperbaric bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03415087

R47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

sequential intrathecal injection of fentanyl and bupivacaine

Active Comparator group

Description:

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

Treatment:

Drug: hyperbaric bupivacaine

Drug: fentanyl

Procedure: sequential intrathecal injection

rapid sequential intrathecal injection of fentanyl and bupiva

Experimental group

Description:

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.

Treatment:

Drug: hyperbaric bupivacaine

Drug: fentanyl

Procedure: sequential intrathecal injection