Pregnancy RelatedNCT05056142
Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor
A study testing Epidural Anesthesia and Spinal Analgesia in people with Pregnancy Related, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- Epidural Anesthesia and Spinal Analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Sep 2021to 1 Oct 2022
- 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
- Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination)
- Aged 18-40 years old
- Single, term pregnant with normal fetal heart rate
- Request neuroaxial analgesia
Who cannot join
- Parturient who refuses to participate,
- American Society of Anesthesiologists (ASA) physical status >II,
- Body mass index more than 35 kg/m2
- Severe pre-eclampsia or eclampsia
- Uncontrolled thyrotoxicosis
- Cardiovascular troubles (e.g. stenotic valvular heart disease or cardiomyopathy)
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- Increased intracranial tension due to a space-occupying lesion
- Any contraindication to regional anesthesia such as local skin or soft tissue infection, coagulopathy or receiving anticoagulant therapy, thrombocytopenic, uncorrected hypovolemia, preexisting neurologic deficits, spinal deformity or previous spine surgery.
- Hypersensitivity to the study drugs
- Parturient who scheduled for emergency cesarean section due to fetal distress, antepartum hemorrhage, multiple gestation or fetal malpresentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial
The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.
- Conditions
- Pregnancy Related
- Being tested
- Epidural Anesthesia, Spinal Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnesthesiaProcedure or surgery
Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.
Spinal AnalgesiaProcedure or surgery
Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Anesthesia | Active comparator | Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL Receives: Procedure: Epidural Anesthesia |
| Spinal Anesthesia | Active comparator | Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume. Receives: Procedure: Spinal Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to perform the block
The time from the preparation of the block until the full injection of anesthetic drugs,
Measured: Intraoperative
Secondary outcomes (3)
Mean arterial blood pressure (MAP)
MAP will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor
Measured: Intraoperative
Heart rate (HR)
HR will be recorded at baseline; 5 minutes prior to the neuroaxial block, and at 5 minutes, 10 minutes, 15 minutes, and 20 minutes after the injection of the local anesthetic and then every 15 minutes till the end of third stage of labor
Measured: Intraoperative
Number of participnts with Postoperative nausea and vomiting (PONV)
PONV will be recorded and categorized as 'no PONV, mild PONV, moderate PONV, and severe PONV'
Measured: First 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start14 Sep 2021
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Mohammed Alansary Amin Ahmed Helwa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056142
- Sponsor's protocol ID
- FMASU R 155/2021
- Status last verified
- Dec 2022
- First submitted
- 15 Sep 2021
- Last updated
- 7 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Versus Low-dose Spinal for Analgesia of Late First Stage of Labor: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05056142
- Acronym / sponsor ID
- FMASU R 155/2021
- Conditions
- Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 24 Sep 2021 (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.
The aim of this study is to compare the effect of epidural analgesia versus low-dose spinal analgesia in parturient in the late first stage of labor regarding time needed to perform the block, duration of the intra- and postoperative analgesia and incidence of procedure related adverse events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural Anesthesia | Active comparator | Procedure: Epidural AnesthesiaPatients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL |
| Spinal Anesthesia | Active comparator | Procedure: Spinal AnalgesiaPatients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Parturient with normal vaginal delivery in late first stage of labor (cervical dilatation ≥ 6 cm by examination)
- Aged 18-40 years old
- Single, term pregnant with normal fetal heart rate
- Request neuroaxial analgesia
Key exclusion criteria (10 listed)
- Parturient who refuses to participate,
- American Society of Anesthesiologists (ASA) physical status >II,
- Body mass index more than 35 kg/m2
- Severe pre-eclampsia or eclampsia
- Uncontrolled thyrotoxicosis
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 |
|---|---|---|
| Epidural AnesthesiaPatients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL. | Procedure or surgery | Epidural Anesthesia |
| Spinal AnalgesiaPatients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume. | Procedure or surgery | Spinal Anesthesia |
Primary outcome
The time to perform the block
Time frame: Intraoperative
The time from the preparation of the block until the full injection of anesthetic drugs,
3 secondary outcomes
Mean arterial blood pressure (MAP)
Time frame: Intraoperative
Heart rate (HR)
Time frame: Intraoperative
Number of participnts with Postoperative nausea and vomiting (PONV)
Time frame: First 24 hours postoperatively
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 7 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural Anesthesia and Spinal Analgesia in people with Pregnancy Related, run by Ain Shams University at 1 site in Egypt.
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 4 inclusion and 10 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The time to perform the block (time frame: Intraoperative). 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 7 Dec 2022.