COMPARISON OF A DRUG NAMED ROPIVACAINE AT A PARTICULAR CONCENTRATION USED WITH ADDITION OF ANOTHER DRUG NAMED FENTANYL FOR RELIEVING PAIN DURING LABOUR USING AN INJECTION AT THE BACK NAMED DURAL PUNCTURE EPIDURAL TECHNIQUE

EFFICACY OF 0.1% ROPIVACAINE WITH AND WITHOUT FENTANYL USING DURAL PUNCTURE EPIDURAL TECHNIQUE FOR LABOUR ANALGESIA- A RANDOMISED DOUBLE BLIND CLINICAL TRIAL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/09/021041

Enrollment

100

Registered

2019-09-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Interventions

Intervention1: 0.1%ROPIVACAINE: EFFICACY OF 12 ML OF 0.1% ROPIVACAINE INTERMITTENT BOLUS IS EVALUATED FOR LABOR ANALGESIA BY DURAL PUNCTURE EPIDURAL TECHNIQUE IN TERMS OF ONSET, DURATION AND QUALITY O

Eligibility

Inclusion criteria

Inclusion criteria: Primigravida with singleton pregnancy

Exclusion criteria

Exclusion criteria: Complicated pregnancy, High risk pregnancy, CPD, Foetal anomaly, Local anaesthetics allergy, Coagulopathy, Spine abnormalities.

Design outcomes

Primary

Measure	Time frame
Primary Objective : 1. Quality of analgesia Timepoint: assessed after and in every 2 min interval from the time of injection of initial bolus of the study drug. Analgesia was considered adequate when the pain score reduced to VAS 3.	—

Secondary

Measure	Time frame
Secondary Objective: 1. Onset of analgesia 2. Degree of motor blockade 3. Duration of analgesia 4. Mode of delivery 5. Incidence of PDPH 6. Fetal outcome by APGAR score 7. Side-effects- hemodynamics, pruritis, urinary retention Timepoint: 1.Time taken from the epidural topup to decrease in VAS score3 2. Assessedd very 5-15minutes after giving the drug 3. Time duration between VAS3 to VAS3 4. Instrumental / Section 5. Patient complaining frontal headache on sitting after 24hrs and relieved by lying supine 6. Assessed at 1minute & 5minute after child birth 7. Assessed throughout the study from the time of epidural till the time of discharge.	—

Measure

Time frame

Secondary Objective: 1. Onset of analgesia 2. Degree of motor blockade 3. Duration of analgesia 4. Mode of delivery 5. Incidence of PDPH 6. Fetal outcome by APGAR score 7. Side-effects- hemodynamics, pruritis, urinary retention Timepoint: 1.Time taken from the epidural topup to decrease in VAS score3 2. Assessedd very 5-15minutes after giving the drug 3. Time duration between VAS3 to VAS3 4. Instrumental / Section 5. Patient complaining frontal headache on sitting after 24hrs and relieved by lying supine 6. Assessed at 1minute & 5minute after child birth 7. Assessed throughout the study from the time of epidural till the time of discharge.

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Countries

India

Contacts

Public ContactRani P

MAHATMA GANDHI MEDICAL COLLEGE

anaesrani@gmail.com9443116908

Outcome results

None listed

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