Comparison of Levobupivacaine with Fentanyl vs Ropivacaine with Fentanyl in Thoracic Epidural for post thoracotomy pain relief

A randomized double blind interventional study comparing effect of Fentanyl as an adjuvant to Levobupivacaine vs Ropivacaine in Thoracic Epidural analgesia for post thoracotomy pain relief at SMS Medical College and Hospital Jaipur during 2019-2021

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026296

Enrollment

Registered

2020-07-01

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: J00-J99- Diseases of the respiratory system

Interventions

Intervention1: Injection Levobupivacaine with Fentanyl: Injection Levobupivacaine (0.2%) 6ml in 20ml Normal saline with Injection Fentanyl 20mcg bolus in epidural space followed by Injection Levobupiv

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing thoracotomy Patients willing to give written informed consent. Normal mental status Patients of either sex ASA Grade II & III Age Groups-18-60 years Weighing 45 to 65 kg Height- 153-183cm (5-6feet)

Exclusion criteria

Exclusion criteria: Patient refusal. Inability to understand Visual Analogue Pain. Allergic to the drugs involved in the study. Bleeding disorders or on anticoagulants. Infection at local site. Thoracic spine deformity.

Design outcomes

Primary

Measure	Time frame
1.To assess and compare need of first rescue analgesia in both groups. 2.To assess and compare in number of rescue analgesia required in first 24 hours in both groups. Timepoint: From the end of surgery to 48 hours post-op.	—

Secondary

Measure	Time frame
To assess and compare the hemodynamic variables- Heart Rate (HR), Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP) in the post-operative period To assess and compare the analgesia score i.e. Visual analogue scale (VAS), RAMSAY Sedation Score and Peak Expiratory Flow Rate (PEFR) at extubation, 6 hours, 12 hours and 24 hours in both groups To assess and compare the difference in the time of extubation of the patient and ICU stay in both the groups. Timepoint: From the end of surgery to 48 hours post-op.	—

Measure

Time frame

To assess and compare the hemodynamic variables- Heart Rate (HR), Systolic Blood Pressure(SBP), Diastolic Blood Pressure(DBP), Mean Arterial Pressure(MAP) in the post-operative period To assess and compare the analgesia score i.e. Visual analogue scale (VAS), RAMSAY Sedation Score and Peak Expiratory Flow Rate (PEFR) at extubation, 6 hours, 12 hours and 24 hours in both groups To assess and compare the difference in the time of extubation of the patient and ICU stay in both the groups. Timepoint: From the end of surgery to 48 hours post-op.

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Countries

India

Contacts

Public ContactDr AYESHA ARIF

SMS Medical College

dranjumsaiyed@gmail.com9214021930

Outcome results

None listed

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