Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Elective Caesarean Section

Intervention / Treatment
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* Procedure: sequential intrathecal injection
* Drug: hyperbaric bupivacaine
* Drug: fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sequential intrathecal injection of fentanyl and bupivacaine<br>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<br>* intrathecal injection of fentanyl and hyperbaric bupivacaine<br>* Other names: sequential spinal anaesthesia;Drug: hyperbaric bupivacaine<br>* intrathecal injection of intrathecal bupivacaine<br>* Other names: heavy marcaine;Drug: fentanyl<br>* intrathecal injection of fentanyl<br>* Other names: opioid;|
| Experimental: rapid sequential intrathecal injection of fentanyl and bupiva<br>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<br>* intrathecal injection of fentanyl and hyperbaric bupivacaine<br>* Other names: sequential spinal anaesthesia;Drug: hyperbaric bupivacaine<br>* intrathecal injection of intrathecal bupivacaine<br>* Other names: heavy marcaine;Drug: fentanyl<br>* intrathecal injection of fentanyl<br>* Other names: opioid;|

What is the study measuring?
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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 |