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The effect of controlled alcohol use on quality of life, stress, and healing in patients undergoing surgery for facial fracture

Impact of therapeutic administration of alcohol on perioperative Quality of Life (QoL) and treatment outcomes in alcoholics undergoing surgery for maxillofacial trauma – A Randomized Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/082706
Enrollment
36
Registered
2025-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: M959- Acquired deformity of musculoskeletal system, unspecified

Interventions

Intervention1: STUDY GROUP Patients with Alcohol Use Disorder requiring surgery for facial fracture: Intervention agent - alcohol 40% ABV in the postoperative period Dose and duration - (0.5gm/kg b

Sponsors

Elavenil Panneerselvam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -ASA grade III (American Society of Anesthesiologists - physical status classification system) patients, due to alcohol use disorder -Patients with established Alcohol Use Disorder (AUD) according to DSM-5 (Diagnostic & Statistical Manual of Mental Disorders) Criteria – mild & moderate grade -Patients with intake of atleast 60 g of ethanol (150ml of distilled spirit ) per day for at least 1 yr preoperatively -AUDIT (Alcohol Use Disorder Identification Test by WHO) scale – risk zone 1, 2, 3 -Patients with fractures of the mandible -Patients who are responsive with GCS score of 15 and ambulatory -Patients belonging to upper lower and lower middle class according to modified Kuppuswamy socioeconomic status Patients and family consenting for the study

Exclusion criteria

Exclusion criteria: Patients lesser than 21 years and greater than 50 years. -Patients with head injury and poly trauma -Patients with systemic problems which compromises wound healing -Patients with drinking in moderation (2drinks or less in a day for men; 1 drink or less for women according to National Institute on Alcohol Abuse and Alcoholism) -Patients with smoking -Patients who are non-compliant to the peri-operative protocol -AUDIT zone 4, CIWA-severe grade (Clinical Institute Withdrawal Assessment of Alcohol Scale) -AST/ALT ratio more than 2 (AST- aspartate aminotransferase; ALT- alanine aminotransferase) -Patients developing AWS (Alcohol Withdrawal Syndrome) after admission

Design outcomes

Primary

MeasureTime frame
1. To evaluate peri operative stress levels 2. To evaluate quality of lifeTimepoint: 1. Post trauma, postoperative day 1 and postoperative 1,2,4,6 weeks 2. Post trauma, postoperative day 1 and postoperative 1,2,4,6 weeks

Secondary

MeasureTime frame
3. To evaluate soft tissue healing 4. To evaluate fracture healing 4.a biochemical evaluation 4.b ImagingTimepoint: 3. 7th, 14th and 21st postoperative days 4.a Preoperative and 30th postoperative day 4.b Preoperative, 4th and 8th week postoperatively

Countries

India

Contacts

Public ContactElavenil Panneerselvam

SRM Dental College and Hospital

dean.acad@dental.srmrmp.edu.in9500058376

Outcome results

None listed

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