Epidural AnalgesiaPhase 4NCT04397406

Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

A Phase 4 study testing levobupivacaine, Dexmedetomidine and Fentanyl in people with Epidural Analgesia and Painless Labor, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics. The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal… Read more about this study

Who is it for?: Ages 21 to 41 years
Conditions the study is for: Epidural Analgesia, Painless Labor, Dexmedetomidine
What is being tested?: levobupivacaine, Dexmedetomidine and Fentanyl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteEgypt
Study dates: 1 Jul 2020to 31 Oct 2021
Phase: Phase 4
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 21 to 41 years
All sexes
No healthy volunteers
Adult

Who may be able to join

American Society of Anesthesiologists (ASA) physical status class II and III,
Full term pregnancy.

Who cannot join

Patient refusal to epidural analgesia,
Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
Cardiac diseases
Severe pre-eclampsia,
Breech presentations
Antepartum hemorrhage
Cephalopelvic disproportion
Body mass index ≥40 kg/m2.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Tanta University Hospitals
Tanta, Gharbia Governorate, 31527

Other trials in Egypt

About this study

Official title: Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.

The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Conditions: Epidural Analgesia, Painless Labor, Dexmedetomidine, Fentanyl, Levobupivacaine
Being tested: levobupivacaine, Dexmedetomidine, Fentanyl

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

levobupivacaineDrug
The patients will receive 15 ml of 0.125% levobupivacaine.
DexmedetomidineDrug
The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.
FentanylDrug
The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.

Study groups in NCT04397406
Study group	Role	What they receive
Group C (Control group)	Active comparator	pidural analgesia with levobupivacaine alone Receives: Drug: levobupivacaine
Group D (Dexmedetomidine group)	Experimental	Epidural analgesia with levobupivacaine and dexmedetomidine Receives: Drug: levobupivacaine; Drug: Dexmedetomidine
Group F (Fentanyl group)	Experimental	Epidural analgesia with levobupivacaine and fentanyl Receives: Drug: levobupivacaine; Drug: Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

Duration of maternal analgesia
Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4.
The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain).
Measured: 24 hours after epidural injection

Secondary outcomes (2)

Onset of maternal analgesia.
The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) <3.
Measured: One hour after epidural injection
Complications of drugs of epidural technique
Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever)
Measured: 24 hours after epidural injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 202031 Oct 2021

First posted21 May 2020
Study start1 Jul 2020
Primary completion31 Oct 2021
Study completion31 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
More trials run by Tanta 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients. Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04397406
Sponsor's protocol ID: 33447/10/19
Status last verified: Mar 2022
First submitted: 18 May 2020
Last updated: 28 Mar 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention

All Epidural Analgesia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study
ClinicalTrials.gov ID: NCT04397406
Acronym / sponsor ID: 33447/10/19
Conditions: Epidural Analgesia, Painless Labor, Dexmedetomidine, Fentanyl, Levobupivacaine
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Tanta UniversityUniversity, hospital or other
Study start: 1 Jul 2020 (actual)
Primary completion: 31 Oct 2021 (actual)
Study completion: 31 Oct 2021 (actual)
First posted: 21 May 2020 (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.

Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics.

The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients. Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl

Arm	Type	Receives
Group C (Control group)	Active comparator	Drug: levobupivacainepidural analgesia with levobupivacaine alone
Group D (Dexmedetomidine group)	Experimental	Drug: levobupivacaine, Drug: DexmedetomidineEpidural analgesia with levobupivacaine and dexmedetomidine
Group F (Fentanyl group)	Experimental	Drug: levobupivacaine, Drug: FentanylEpidural analgesia with levobupivacaine and fentanyl

Who may qualify

Ages: 21 to 41 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

American Society of Anesthesiologists (ASA) physical status class II and III,
Full term pregnancy.

Key exclusion criteria (8 listed)

Patient refusal to epidural analgesia,
Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis),
Cardiac diseases
Severe pre-eclampsia,
Breech presentations

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
levobupivacaineThe patients will receive 15 ml of 0.125% levobupivacaine.	Drug	Group C (Control group), Group D (Dexmedetomidine group), Group F (Fentanyl group)
DexmedetomidineThe patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.	Drug	Group D (Dexmedetomidine group)
FentanylThe patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.	Drug	Group F (Fentanyl group)

Primary outcome

Duration of maternal analgesia
Time frame: 24 hours after epidural injection
Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4. The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain).

2 secondary outcomes

Onset of maternal analgesia.
Time frame: One hour after epidural injection
Complications of drugs of epidural technique
Time frame: 24 hours after epidural injection

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 Mar 2022.
Individual participant dataSharing planned: No

Related trials for Epidural Analgesia

Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Not yet recruiting
Dural Puncture Epidural With 27G vs 26G Needles Versus Standard Epidural for Elective Cesarean Delivery
Cesarean Section, Anesthesia, Obstetrical
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention

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 Phase 4 study testing levobupivacaine, Dexmedetomidine and Fentanyl in people with Epidural Analgesia and Painless Labor, run by Tanta 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 2 inclusion and 8 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 Mar 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 maternal analgesia (time frame: 24 hours after epidural injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04397406.

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 Mar 2022.