Comparison of the effectiveness of Transdermal opioids for prevention of Chronic Pain after Surgery in Cancer Patients
Phase 4
- Conditions
- Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx
- Registration Number
- CTRI/2019/03/018245
- Lead Sponsor
- niversity College of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
•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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br/ ><br>Proportion of patients achieving NRS-pain score â?¤3/10Timepoint: <br/ ><br>Proportion of patients achieving NRS-pain score â?¤3/10
- Secondary Outcome Measures
Name Time Method 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