Labor PainNCT05746351
Analgesic Additives to Epidural Bupivacaine in Normal Labor
A study testing Dexmedetomidine, fentanyl and Nalbuphine in people with Labor Pain, run by Assiut University.
Trial summary
The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Dexmedetomidine, fentanyl and Nalbuphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Jul 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- >/= 18 years of age
- American Society of Anesthesiologists (ASA) Physical Status 2 or 3
- Full term pregnancy (>37 gestational weeks)
- Planning vaginal delivery
- Planning epidural labor analgesia
- Vertex presentation
Who cannot join
- Patient refusal to epidural analgesia,
- Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
- Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
- hemodynamic instability, severe aortic or mitral stenosis)
- Severe pre-eclampsia,
- Breech presentations
Show all 12Show fewer
- Antepartum hemorrhage
- Cephalopelvic disproportion
- Body mass index ≥40 kg/m2.
- Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac]
- Known or suspected fetal abnormalities
- Inability to communicate or participate in study procedures
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.
The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.
Read the detailed description
Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased .
Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction .
Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia .
Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics.
Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .
It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension .
Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses .
The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .
- Conditions
- Labor Pain
- Being tested
- Dexmedetomidine, fentanyl, Nalbuphine
- Keywords
- epidural anathesia, normal labor
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor
fentanylDrug
Also called Durogesic
a group will receive epidural Bupivacaine with fentanyl in normal labor
NalbuphineDrug
Also called Nalufin
a group will receive epidural Bupivacaine with Nalbuphine in normal labor
| Study group | Role | What they receive |
|---|---|---|
| epidural Bupivacaine with Dexmedetomidine in normal labor | Active comparator | Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml Receives: Drug: Dexmedetomidine |
| epidural Bupivacaine with fentanyl in normal labor | Active comparator | Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml. Receives: Drug: fentanyl |
| epidural Bupivacaine with Nalbuphine in normal labor | Active comparator | Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine. Receives: Drug: Nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score for pain
changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
Measured: before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.
- Masking
- None (open label)
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanob Fathy Zareef, Assiut University
- Investigators
- Zein EA Zareh Hassan, professor, Study chair, Assiut UniversityElwani Eldramy Elsenosi, professor, Study director, Assiut UniversityKhaled Tolba Younes, Lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746351
- Sponsor's protocol ID
- epidural additives in labor
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.
- ClinicalTrials.gov ID
- NCT05746351
- Acronym / sponsor ID
- epidural additives in labor
- Conditions
- Labor Pain
- Keywords
- epidural anathesia, normal labor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Feb 2023 (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 the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.
Detailed description
Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased .
Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction .
Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia .
Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics.
Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings .
It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension .
Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses .
The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.
| Arm | Type | Receives |
|---|---|---|
| epidural Bupivacaine with Dexmedetomidine in normal labor | Active comparator | Drug: DexmedetomidineEpidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml |
| epidural Bupivacaine with fentanyl in normal labor | Active comparator | Drug: fentanylEpidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml. |
| epidural Bupivacaine with Nalbuphine in normal labor | Active comparator | Drug: NalbuphineEpidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- >/= 18 years of age
- American Society of Anesthesiologists (ASA) Physical Status 2 or 3
- Full term pregnancy (>37 gestational weeks)
- Planning vaginal delivery
- Planning epidural labor analgesia
Key exclusion criteria (12 listed)
- Patient refusal to epidural analgesia,
- Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity)
- Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine)
- hemodynamic instability, severe aortic or mitral stenosis)
- Severe pre-eclampsia,
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 |
|---|---|---|
| DexmedetomidineAlso: precedexa group will receive epidural Bupivacaine with Dexmedetomidine in normal labor | Drug | epidural Bupivacaine with Dexmedetomidine in normal labor |
| fentanylAlso: Durogesica group will receive epidural Bupivacaine with fentanyl in normal labor | Drug | epidural Bupivacaine with fentanyl in normal labor |
| NalbuphineAlso: Nalufina group will receive epidural Bupivacaine with Nalbuphine in normal labor | Drug | epidural Bupivacaine with Nalbuphine in normal labor |
Primary outcome
VAS score for pain
Time frame: before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Paramasivan A, Lopez-Olivo MA, Foong TW, et al. Intrathecal dexmedetomidine and postoperative pain: a systematic review and meta-analysis of randomized controlled trials. Eur J Pain. 2020;24(7):1215-1227Link provided by the sponsor.
- Senapati LK, Samanta P. Effect of intravenous versus intrathecal dexmedetomidine on characteristics of hyperbaric bupivacaine spinal anesthesia in lower limb surgery. Asian J Pharm Clin Res. 2018;11:427-430.Link provided by the sponsor.
- Santpur MU, Kahalekar GM, Saraf N, et al. Effect of intravenous dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: a prospective randomized control study. Anesth Essays Res. 2016;10(3):497-501.Link provided by the sponsor.
- \] Niu XY, Ding XB, Guo T, et al. Effects of intravenous and intrathecal dexmedetomidine in spinal anesthesia: a meta-analysis. CNS Neurosci Ther. 2013;19(11):897-904.Link provided by the sponsor.
- Camann WR, Hurley RH, Gilbertson LI, et al. Epidural nalbuphine for analgesia following caesarean delivery: dose-response and effect of local anaesthetic choice. Can J Anaesth. 1991;38(6):728-732.Link provided by the sponsor.
- \] Chatrath V, Attri JP, Bala A, et al. Epidural nalbuphine for postoperative analgesia in orthopedic surgery. Anesth Essays Res. 2015;9(3):326.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Zein EA Zareh Hassan, professor study chair
Assiut University
Elwani Eldramy Elsenosi, professor study director
Assiut University
Khaled Tolba Younes, Lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, fentanyl and Nalbuphine in people with Labor Pain, run by Assiut 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abanob Fathy Zareef, MBBS (01010424707, bebofathy47@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score for pain (time frame: before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery.). 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 27 Feb 2023.