Comparision of Transdermal Buprenorphine patch and Non opoid analgesia in Oral submucous fibrosis Patients.
- Conditions
- Health Condition 1: K135- Oral submucous fibrosis
- Registration Number
- CTRI/2023/06/053432
- Lead Sponsor
- AIIMS Jodhpur
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients in the age group between 18- 65 years
2.Patient with mouth opening <25mm with unilateral or bilateral fibrotic bands
3.Good physical and mental condition (ASA I and II )
4.Absence of infection or trauma prior to the surgery.
1.Age <18 years and >65 years.
2.Patients/with life-threatening cardio-respiratory co-morbidities with increasing risk of complication during GA like previous MI/under treatment for CAD, COPD patients, severe hepatic and renal impairment, patients with head injury (a condition that increased amount of pressure in the brain),opioid-tolerant patients.
3.A history of allergy to the drugs used in the present study.
4.All pregnant and lactating females.
5.Alcohol or narcotics abusers.
6.Patients with hypersensitivity to buprenorphine
7.Patients who are taking anti-depressants, and central nervous system depressants.
8.Patients who are taking other opioid drugs, and muscle relaxants like dantrolene, and baclofen.
9.Patients who are taking anti-retroviral, antifungal drugs.
10.Patients with a coagulation disorder.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of the Transdermal Buprenorphine patch in perioperative pain management in OSMF patients while doing structured physiotherapy.Timepoint: Day 0, 1st, 3rd, 5th, 7th, 15th-day 1st month, and 3rd month.
- Secondary Outcome Measures
Name Time Method a.To evaluate pain in the perioperative period and during mouth-opening exercises. <br/ ><br>b.To compare the mouth opening achieved postoperatively in both groups at various time intervals <br/ ><br>c.To assess patientâ??s compliance in the form of an Exercise Adherence scale at various time intervals <br/ ><br>d.To compare muscle function using EMGs of anterior temporalis, masseter and orbicularis oris. <br/ ><br>e.To evaluate the Quality of life in OSMF patients. <br/ ><br>f.To analyse complications occurring in both groups. <br/ ><br>Timepoint: 1.3hrs, 6hrs, 12hrs, 24hrs. 2.Day 0, 1st, 3rd, 5th, 7th, 15th-day 1st month, and 3rd month. <br/ ><br>3. Preoperative and 3rd month.