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Comparing Pain Relief options for Epidural Labor :Levobupivacaine Alone versus Levobupivacaine Plus Nalbuphine.

Comparison of Levobupivacaine versus Levobupivacaine Plus Nalbuphine for Epidural Labor Analgesia. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071020
Enrollment
60
Registered
2024-07-22
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Levobupivacaine plus Nalbuphine: Inj. Levobupivacaine 0.1 percent +1mg Inj. Nalbuphine. Epidural will be performed at L2-L3 intervertebral space with 18G Touhy needle using median appro

Sponsors

Datta Meghe Institute of Higher Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age range: Primigravida women at term 19-50 years. 2.Gestation age: Pregnant women at term 37-42 weeks of gestation. 3.Labor status :Women in active labor ,often defined as regular contractions with significant cervical dilatation e.g.,3-4 cm for nulliparas-Latent phase of stage I of labor. 4.Health Status: Physically healthy women with ASA physical status I or II. 5.Singleton Pregnancy, Vertex Presentation. 6.Able and willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1.Patient not willing to participate in study. 2. ASA grade III-IV. 3.Known allergy to any of the study drugs. 4.known or suspected coagulopathy. 5.Contraindications to Epidural Anesthesia: Such as infection at the injection site, sever hypovolemia, or increased intracranial pressure.

Design outcomes

Primary

MeasureTime frame
Evaluation of effect of inj. Nalbuphine as adjuvant to inj. Levobupivacaine in providing pain relief during epidural labor analgesia. It will be assessed by onset of action and duration of analgesia and degree of motor blockade.Timepoint: Assessment will be done at the end 1 year.

Secondary

MeasureTime frame
1.To observe and compare labor related outcomes such as the duration of labor ,incidence of instrumental delivery ,or caesarean sections. 2.To compare Neonatal outcome in two groups focusing on APGAR scores and any need for neonatal intensive care admissions. 3.To Evaluate side effects and complications if any. 4.To Assess and compare the level of patient satisfaction in terms of visual analogue scale in two groups.Timepoint: Assessment will be done at the end 1 year.

Countries

India

Contacts

Public ContactDr Sanjot Ninave

Datta Meghe Institute Of Higher Education And Research

drsusann02@rediffmail.com992123404

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026