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

Phase 3

Conditions: Health Condition 1: O- Medical and Surgical

Registration Number: CTRI/2024/07/071020

Lead Sponsor: Datta Meghe Institute of Higher Education and Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1.To observe and compare labor related outcomes such as the duration of labor ,incidence of instrumental delivery ,or caesarean sections. <br/ ><br>2.To compare Neonatal outcome in two groups focusing on APGAR scores and any need for neonatal intensive care admissions. <br/ ><br>3.To Evaluate side effects and complications if any. <br/ ><br>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.