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Comparison of low dose and standard dose of fentanyl patch on adult patients undergoing spine surgery for post operative pain relief

A comparison of transdermal fentanyl patch 12.5 microgram versus 25 microgram for post operative analgesia in adults undergoing spine surgery - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/097688
Enrollment
52
Registered
2025-11-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere Health Condition 2: E119- Type 2 diabetes mellitus without complications Health Condition 3: I10- Essential (primary) hypertension

Interventions

Intervention1: Nil: Nil

Sponsors

Self sponsor
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and ASA 2 undergoing elective posterior spine instrumentation and stabilisation surgery under general anaesthesia

Exclusion criteria

Exclusion criteria: Opioid -dependent and sensitive patients, patients on antidepressant drugs, haemodynamically unstable, morbidly obese patients, peptic ulcers, uncontrolled systemic illness (Systemic hypertension and diabetes mellitus), impaired kidney or liver functions, history of intake of non-steroidal anti- inflammatory drugs or opioids within 24h before surgery or allergy to the used medications, coagulation defect, local infection at the site of application of transdermal patch, patient refusal will be excluded from the study

Design outcomes

Primary

MeasureTime frame
1. Comparison of mean Numerical Rating Scale at different time intervals 2. First time of asking for rescue analgesia 3. Consumption of total Diclofenac and Tramadol consumption in 72 hours 4. Assessment of post operative sedation using Ramsay Sedation ScoreTimepoint: 30 minutes for the first two hours, 4 hour intervals for the next 12 hours, 12 hourly interval until 72 hours

Secondary

MeasureTime frame
1. Post operative hemodynamics - Mean arterial pressure, heart rate 2. POst operative side effects - post operative nausea and vomiting, skin irritation and itching at the site of application of patch, hypotension, bradycardia, dyspnea, urinary retentionTimepoint: 72 hours

Countries

India

Contacts

Public ContactJamie Ann Varghese

Kasturba Medical College, Manipal

malavika.kulkarni@manipal.edu9844241620

Outcome results

None listed

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