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Comparison of the effectiveness of Transdermal opioids for prevention of Chronic Pain after Surgery in Cancer Patients

Comparison of the efficacy and safety of Transdermal Fentanyl Versus Transdermal Buprenorphine for prevention of Chronic Persistent Post Surgical Pain in Head and Neck Cancer Patients : A Randomized, Single-Blinded, Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018245
Enrollment
40
Registered
2019-03-25
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: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Group-TDB: Transdermal Buprenorphine patch dose of 10 microgram will be applied on skin on post operative day 6 and followed on 1st , 2nd, 4th, 6th and 8th week post operatively for to

Sponsors

University College of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Operated case of Head and Neck cancer, managed with Standard Postoperative Pain Management Protocol, for initial five days of post-operative period with Pain intensity >= 4/10 of Numerical Rating Scale-pain scale on post-operative day 6

Exclusion criteria

Exclusion criteria: •Evidence of other sources of pain that may confound the diagnosis •Recent history of any other surgery other than that for HNC •Patients with past H/o MI, DM, pancreatitis and vasculitis. •Patients with evidence of hepatic or renal impairment. •Patients having allergy/intolerance to oral/parenteral/transdermal patches.

Design outcomes

Primary

MeasureTime frame
Proportion of patients achieving NRS-pain score â?¤3/10Timepoint: Proportion of patients achieving NRS-pain score â?¤3/10

Secondary

MeasureTime frame
Comparison of GPE ScoreTimepoint: At 1st, 2nd, 4th, 6th and 8th week post patch application;Comparison of NPSI ScoreTimepoint: At 1st, 2nd, 4th, 6th and 8th week post patch application;Comparison of PDI ScoreTimepoint: At 1st, 2nd, 4th, 6th and 8th week post patch application;Comparison of PDQTimepoint: At 1st, 2nd, 4th, 6th and 8th week post patch application;Comparison of SF-12 scoreTimepoint: At 1st, 2nd, 4th, 6th and 8th week post patch application;Modulation in mRNA expressions of IL-6 and mTORC1 genesTimepoint: Pre-treatment and at the end of 12th week post treatment

Countries

India

Contacts

Public ContactDr Geetanjali T Chilkoti

University College of Medical Sciences and GTB

akkibahl91@gmail.com9582146662

Outcome results

None listed

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