Analgesic Additives to Epidural Bupivacaine in Normal Labor

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2025-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

NCT04397406

Epidural Analgesia Painless Labor Dexmedetomidine +2 more

COMPLETED PHASE4

Spinal Analgesia in Labour Pain

NCT07332130

Labour Analgesia

NOT_YET_RECRUITING PHASE1

Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

NCT05327088

Epidural Anesthesia Labor Pain

COMPLETED PHASE2

Epidural Neostigmine for Labor Pain

NCT00779467

Labor Pain

COMPLETED PHASE1

DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

NCT05840328

Painless Vainal Labour

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

epidural Bupivacaine with Dexmedetomidine in normal labor

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor

epidural Bupivacaine with fentanyl in normal labor

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml.

Group Type ACTIVE_COMPARATOR

fentanyl

Intervention Type DRUG

a group will receive epidural Bupivacaine with fentanyl in normal labor

epidural Bupivacaine with Nalbuphine in normal labor

Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine.

Group Type ACTIVE_COMPARATOR

Nalbuphine

Intervention Type DRUG

a group will receive epidural Bupivacaine with Nalbuphine in normal labor

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor

Intervention Type DRUG

fentanyl

a group will receive epidural Bupivacaine with fentanyl in normal labor

Intervention Type DRUG

Nalbuphine

a group will receive epidural Bupivacaine with Nalbuphine in normal labor

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

precedex Durogesic Nalufin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* \>/= 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

Exclusion Criteria

* 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
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes