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A research study comparing pain relief effectiveness between levobupivacaine alone and levobupivacaine combined with fentanyl during elective lower back surgery in adults.

Comparison of analgesic efficacy of levobupivacaine with or without fentanyl using thoracolumbar inter-fascial plane block in adults undergoing elective lumbar spine surgery: A randomized control trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/068656
Enrollment
90
Registered
2024-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Thoracolumbar inter-fascial plane block: The enrolled patients will be randomly allocated via computer-generated random numbers into two groupS. Patients will receive ultrasound-guided

Sponsors

AIIMS Raebareli
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. BMI between 25-30, 2. Patients classified into the ASA classes I–II, 3. Patients scheduled to undergo posterior lumbar spine fusion surgeries of up to two levels

Exclusion criteria

Exclusion criteria: 1. Patient refusal to undergo the procedure 2. Known allergies to drugs used in regional anesthesia, 3. Local infection at the site of the block. 4. Patients with abnormal liver or kidney function 5. Psychiatric disorders, or those using psychiatric medications 6. Patients with bleeding diathesis or on anticoagulants, 7. Patients using corticosteroids 8. Individuals who had undergone previous spine surgery

Design outcomes

Primary

MeasureTime frame
1. To compare the duration of analgesia between the two groups 2. To compare the total consumption of tramadol in post-operative period of 48 hours between the two groups. Timepoint: 48 Hours

Secondary

MeasureTime frame
1. To compare hemodynamic parameters between the two groups 2. To compare any side effects between the two groups Timepoint: 48 hours

Countries

India

Contacts

Public ContactDr Bhupendra Singh

AIIMS Raebareli

abhiraj997@gmail.com9694744962

Outcome results

None listed

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