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.
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
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.
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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mahmoud Moneeb El-shazly, Tanta University
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