Effects of; Anesthesia, in Labor and DeliveryPhase 2NCT02588417
Intrathecal Dexamethasone and Labor Analgesia
A Phase 2 study testing Dexamethasone and Levobupivacaine in people with Effects of; Anesthesia, in Labor and Delivery, run by ahmed elsakka.
Trial summary
To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Effects of; Anesthesia, in Labor and Delivery
- What is being tested?
- Dexamethasone and Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Oct 2015
- Phase
- Phase 2
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I,II patients schedueled for normal vaginal deliveries
- age between 18-35 years old
Who cannot join
- Patients who refused to participate
- complicated pregnancies
About this study
Official title: Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.
To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.
Read the detailed description
This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.
- Being tested
- Dexamethasone, Levobupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called decadron
4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg
LevobupivacaineDrug
Also called chirocaine
levobupivacaine 2.5 mg
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Active comparator | dexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine Receives: Drug: Dexamethasone; Drug: Levobupivacaine |
| levobupivacaine | Active comparator | levobupivacaine 2.5 mg in 2 ml administered intrathecally during active stage of labor once and alone and then epidural levobupivacaine 7ml of 2.5 mg concentrationis administered till the end of labor Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of spinal analgesia
Measured: 1 day
Secondary outcomes (1)
time from spinal analgesia to delivery
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; Anesthesia, in Labor and DeliveryStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ahmed elsakka
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ahmed elsakka, Kasr El Aini Hospital
- Investigators
- nadia yo helmy, md, Principal investigator, professor of anaesthesia cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588417
- Sponsor's protocol ID
- no id
- Status last verified
- Oct 2015
- First submitted
- 26 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Combined Spinal Epidural for Vaginal Delivery Analgesia: A Comparative Study.
- ClinicalTrials.gov ID
- NCT02588417
- Acronym / sponsor ID
- no id
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ahmed elsakkaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Oct 2015 (estimated)
- 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.
To evaluate the effectiveness of adding dexamethasone to intrathecal levobupivacaine in combined spinal epidural (CSE) analgesia during vaginal delivery.
Detailed description
This prospective double-blind trial included 80 primigravidas during vaginal delivery with a cervical dilatation ≥ 4 cm and 50% effacement randomly assigned to one of two equal groups; Group L received intrathecal levobupivacaine 0.25% in 2 mL and Group LD received intrathecal levobupivacaine 0.25% combined with dexamethasone 4 mg in 2 mL. At first request of analgesia, a combination of 0.25% levobupivacaine with 100 μg fentanyl in 10 ml via the epidural catheter. Further analgesia was provided with 7 ml 0.25% levobupivacaine hourly. The primary outcome measure was the duration of spinal analgesia. Secondary outcome measures include time from spinal analgesia to delivery, total amount of epidurally administered levobupivicaine, adverse effects of neuraxial block and neonatal outcome.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Levobupivacainedexamethasone 4 mg administered intrathecally during active stage of labor once only in combination with levobupivacaine |
| levobupivacaine | Active comparator | Drug: Levobupivacainelevobupivacaine 2.5 mg in 2 ml administered intrathecally during active stage of labor once and alone and then epidural levobupivacaine 7ml of 2.5 mg concentrationis administered till the end of labor |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA physical status I,II patients schedueled for normal vaginal deliveries
- age between 18-35 years old
Key exclusion criteria (2 listed)
- Patients who refused to participate
- complicated pregnancies
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 |
|---|---|---|
| DexamethasoneAlso: decadron4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg | Drug | dexamethasone |
| LevobupivacaineAlso: chirocainelevobupivacaine 2.5 mg | Drug | dexamethasone, levobupivacaine |
Primary outcome
duration of spinal analgesia
Time frame: 1 day
1 secondary outcome
time from spinal analgesia to delivery
Time frame: 1 day
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 28 Oct 2015.
Related trials for Effects of; Anesthesia, in Labor and Delivery
Not yet recruitingObservational study
EPidural's Impact on Contractions and Fetal REsponse
Epidural Anesthesia in Labor and Delivery, Doppler Ultrasound
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.
nadia yo helmy, md principal investigator
professor of anaesthesia cairo university
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Levobupivacaine in people with Effects of; Anesthesia, in Labor and Delivery, run by ahmed elsakka.
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 2 inclusion and 2 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 28 Oct 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 spinal analgesia (time frame: 1 day). 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 28 Oct 2015.