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Ropivacaine with Fentanyl for Post-Operative Epidural Analgesia

Effect of Epidural Ropivacaine Hydrochloride with Fentanyl Citrate at Different Concentrations on Post Operative Analgesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250820003
Enrollment
80
Registered
2025-08-20
Start date
2012-05-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Adult patient for lower limb orthopedic surgery Epidural Analgesia, Ropivacaine Fentanyl Postoperative Pain, Orthopedic Procedures Patient Controlled Analgesia

Interventions

Group 1 is Patient-Controlled Epidural Analgesia (PCEA) with a high concentration, low-volume solution. (Ropivacaine: 0.20%, Fentanyl: 2 mcg/ml). Epidural PCEA pump setting is Demand Dose: 4 ml, Lock
Active Comparator Drug,Active Comparator Drug
Group A (High Concentration): 0.20% Ropivacaine + 2 mcg/ml Fentanyl.,Group B (Low Concentration): 0.10% Ropivacaine + 1 mcg/ml Fentanyl.

Sponsors

Rishi Anand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. ASA 1, 2 2. Adult patient undergoing elective lower limb orthopaedic surgery 3. Combined spinal epidural anaesthesia

Exclusion criteria

Exclusion criteria: 1. Infective focus at back 2. Hypersensitivity to local anaesthetic ropivacaine 3. Received opioid medication within 24 hours before operation 4. Pregnant or females giving breast feeding 5. Patient refusal / inability to use PCA pump

Design outcomes

Primary

MeasureTime frame
Amount of drug consumed Every 6 hour over first 2 postoperative days Mg

Secondary

MeasureTime frame
Post operative nausea Every 6 hour over first 2 postoperative days Incidence in both groups

Countries

India

Contacts

Public ContactRishi Anand

Tata Main Hospital, Jamshedpur

rishi.anand1@tatasteel.com09716548587

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026