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
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proportion of patients achieving NRS-pain score ≤3/10
Study Overview
Brief Summary
This study is proposed to be a one site prospective randomized study where the study participants will be divided by random allocation into two groups, one will receive treatment with TDF and one group will receive TDB pain patch application. After establishing a diagnosis of HNC, baseline assessment shall be done for pain and quality of life. After the initiation of treatment with transdermal pain patches the participants will be followed up for a period of 3 months at the designated time intervals i.e. at the end of 1st week, 2nd week, 4th week, 6th week, 8th week and 12th week. Two ml venous blood samples shall be collected from all the participants. Two such samples will be obtained as baseline and then at 12th week i.e. post commencement of the treatment with TDF and TDB. Gene expression study will be done by utilizing the real time quantitative PCR, mRNA expression of IL-6 and mTORC1 genes shall be performed.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
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
- •â€¢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.
- •â€¢Patients with evidence of hepatic or renal impairment.
- •â€¢Patients having allergy/intolerance to oral/parenteral/transdermal patches.
Outcomes
Primary Outcomes
Proportion of patients achieving NRS-pain score ≤3/10
Time Frame: Proportion of patients achieving NRS-pain score ≤3/10
Secondary Outcomes
- Comparison of PDQ(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of NPSI Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of GPE Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of PDI Score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Comparison of SF-12 score(At 1st, 2nd, 4th, 6th and 8th week post patch application)
- Modulation in mRNA expressions of IL-6 and mTORC1 genes(Pre-treatment and at the end of 12th week post treatment)