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Comparision of Epidural Fentanyl to Epidural Dexmedetomidine on Requirement of Ropivacaine Dose in Patient Controlled Pain relief with epidural During Delivery

Comparison Of Epidural Fentanyl to Epidural Dexmedetomidine on Requirement of Ropivacaine in Patient Controlled Epidural Analgesia During Labour Double Blinded Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069716
Enrollment
50
Registered
2024-07-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery Health Condition 2: 1- Obstetrics

Interventions

Intervention1: Fentanyl Group: Patient will receive 10ml loading dose of 0.1% Ropivacaine with fentanyl 2µg/ml followed by continuous background infusion by patient controlled analgesia pump at rate o

Sponsors

Vijayanagar Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Full term parturients with 37 weeks or greater period of gestation, both primi and multigravida. 2 Singleton pregnancy with vertex presentation. 3 Inactive phase of labour cervical dialation 3 to 4 cms 4 Age more than 20years 5 ASA-2 6 Willing to give consent for labour epidural analgesia 7 Parturient who can understand and able to use PCA pump

Exclusion criteria

Exclusion criteria: 1.Allergy to any of the study drugs 2.Patients with history of significant disorders (Pregnancy induced hypertension, diabetes mellitus, obstetric haemorrhage, other cardiovascular, respiratory, central nervous system or renal system disorders) 3.Significant coagulopathy 4.Other contraindications: localized sepsis, raised ICP etc. 5.Previous LSCS

Design outcomes

Primary

MeasureTime frame
Consumption of Total Dose of Ropivacaine 0.1% in Both the Groups by Patient Controlled Epidural Analgesia in LabourTimepoint: From 4cm Cervical Dilatation till the End of Stage 3 of Labour

Secondary

MeasureTime frame
1.Number of Patient Controlled Analgesia demand bolus 2.NRS at various intervals 3.Maternal SBP, DBP, MAP PR,SPO2,ECG,RR, Temperature 4.Continues FHR monitoring (CTG) 5.Duration of stages of labour-stage 1,2 & 3 6.Incidence of spontaneous delivery, assisted delivery & LSCS 7.Maternal satisfaction -1to 5 scale 8.Neonatal outcome (apgar score1and 5 minutes) 9.Complications such as hypotension,Bradycardia,desaturation, nausea vomiting pruritis Timepoint: Number of Patient Controlled Analgesia demand bolus - from 4cm cervical dilatation till end of stage 3 of labour NRS at various intervals - Prior to Epidural Catheter Placement, After Every 10 minutes Interval For 60 Minutes & Thereafter Hourly Till completion of Labour Maternal SBP, DBP, MAP PR,SPO2,ECG,RR,Temperature-Prior to Epidural Catheter Placement, After Every 10 minutes Interval For 60 Minutes & Thereafter Hourly Till completion of Labour Maternal satisfaction- At the end of labour

Countries

India

Contacts

Public ContactDr Parimala

Vijayanagar Institute of Medical Sciences, Rajiv Gandhi University of Health Sciences.

muskan.hukrani01@gmail.com8951987372

Outcome results

None listed

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