Comparision of Transdermal Buprenorphine patch and Non opoid analgesia in Oral submucous fibrosis Patients.

Comparison of effect of Transdermal Buprenorphine Patch Vs Non-Opioid Analgesia on Postoperative outcomes in Oral Sub mucous Fibrosis Patients: â??A Randomized Control Trialâ??

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/06/053432

Enrollment

Registered

2023-06-01

Start date

Unknown

Completion date

Unknown

Last updated

2023-06-26

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

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Transdermal Buprenorphine patch: A Buprenorphine patch will be applied to an intact hairless spot of the skin the night before the surgery. The date and time of the patch application on

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients in the age group between 18- 65 years 2.Patient with mouth opening 3.Good physical and mental condition (ASA I and II ) 4.Absence of infection or trauma prior to the surgery.

Exclusion criteria

Exclusion criteria: 1.Age 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
a.To evaluate pain in the perioperative period and during mouth-opening exercises. b.To compare the mouth opening achieved postoperatively in both groups at various time intervals c.To assess patientâ??s compliance in the form of an Exercise Adherence scale at various time intervals d.To compare muscle function using EMGs of anterior temporalis, masseter and orbicularis oris. e.To evaluate the Quality of life in OSMF patients. f.To analyse complications occurring in both groups. Timepoint: 1.3hrs, 6hrs, 12hrs, 24hrs. 2.Day 0, 1st, 3rd, 5th, 7th, 15th-day 1st month, and 3rd month. 3. Preoperative and 3rd month.	—

Measure

Time frame

a.To evaluate pain in the perioperative period and during mouth-opening exercises. b.To compare the mouth opening achieved postoperatively in both groups at various time intervals c.To assess patientâ??s compliance in the form of an Exercise Adherence scale at various time intervals d.To compare muscle function using EMGs of anterior temporalis, masseter and orbicularis oris. e.To evaluate the Quality of life in OSMF patients. f.To analyse complications occurring in both groups. Timepoint: 1.3hrs, 6hrs, 12hrs, 24hrs. 2.Day 0, 1st, 3rd, 5th, 7th, 15th-day 1st month, and 3rd month. 3. Preoperative and 3rd month.

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Countries

India

Contacts

Public ContactDr Gayatri Kulkarni

AIIMS Jodhpur

chaudhry_kirti@yahoo.com8003993889

Outcome results

None listed

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