Elective Caesarean SectionNCT03415087
Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine
A study testing sequential intrathecal injection, hyperbaric bupivacaine and fentanyl in people with Elective Caesarean Section, run by Ain Shams University.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Elective Caesarean Section
- What is being tested?
- sequential intrathecal injection, hyperbaric bupivacaine and fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I, II
- Parturients aged from 18-40 years old
- scheduled for elective CS
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Elective Caesarean Section
- Being tested
- sequential intrathecal injection, hyperbaric bupivacaine, fentanyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sequential intrathecal injectionProcedure or surgery
Also called sequential spinal anaesthesia
intrathecal injection of fentanyl and hyperbaric bupivacaine
hyperbaric bupivacaineDrug
Also called heavy marcaine
intrathecal injection of intrathecal bupivacaine
fentanylDrug
Also called opioid
intrathecal injection of fentanyl
| Study group | Role | What they receive |
|---|---|---|
| sequential intrathecal injection of fentanyl and bupivacaine | Active comparator | 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 Receives: Procedure: sequential intrathecal injection; Drug: hyperbaric bupivacaine; Drug: fentanyl |
| rapid sequential intrathecal injection of fentanyl and bupiva | Experimental | 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. Receives: Procedure: sequential intrathecal injection; Drug: hyperbaric bupivacaine; Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of postoperative analgesia
technique provides prolonged post operative analgesia
Measured: 2-5 hours
Secondary outcomes (1)
incidence of hypotension
note if hypotension occurs
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Jan 2016
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Caesarean SectionStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rania Maher Hussien, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415087
- Sponsor's protocol ID
- R47
- Status last verified
- Jan 2018
- First submitted
- 24 Dec 2017
- Last updated
- 30 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Intrathecal Injection of Fentanyl and Hyperbaric Bupivacaine at Different Rates; Does it Make Difference?
- ClinicalTrials.gov ID
- NCT03415087
- Acronym / sponsor ID
- R47
- Conditions
- Elective Caesarean Section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sequential intrathecal injection of fentanyl and bupivacaine | Active comparator | Procedure: sequential intrathecal injection, Drug: hyperbaric bupivacaine, Drug: fentanylintrathecal 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 |
| rapid sequential intrathecal injection of fentanyl and bupiva | Experimental | Procedure: sequential intrathecal injection, Drug: hyperbaric bupivacaine, Drug: fentanylintrathecal 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I, II
- Parturients aged from 18-40 years old
- scheduled for elective CS
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sequential intrathecal injectionAlso: sequential spinal anaesthesiaintrathecal injection of fentanyl and hyperbaric bupivacaine | Procedure or surgery | rapid sequential intrathecal injection of fentanyl and bupiva, sequential intrathecal injection of fentanyl and bupivacaine |
| hyperbaric bupivacaineAlso: heavy marcaineintrathecal injection of intrathecal bupivacaine | Drug | rapid sequential intrathecal injection of fentanyl and bupiva, sequential intrathecal injection of fentanyl and bupivacaine |
| fentanylAlso: opioidintrathecal injection of fentanyl | Drug | rapid sequential intrathecal injection of fentanyl and bupiva, sequential intrathecal injection of fentanyl and bupivacaine |
Primary outcome
Duration of postoperative analgesia
Time frame: 2-5 hours
technique provides prolonged post operative analgesia
1 secondary outcome
incidence of hypotension
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sequential intrathecal injection, hyperbaric bupivacaine and fentanyl in people with Elective Caesarean Section, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of postoperative analgesia (time frame: 2-5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2018.