| CTRI Number |
CTRI/2025/03/082706 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of controlled alcohol use on quality of life, stress, and healing in patients undergoing surgery for facial fracture |
|
Scientific Title of Study
|
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 |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elavenil Panneerselvam |
| Designation |
Professor |
| Affiliation |
SRM Dental College and Hospital |
| Address |
Department of Oral & Maxillofacial Surgery
SRM Dental College & Hospital
Ramapuram
Chennai 600089
Tamil Nadu
India
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenip@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajkumar |
| Designation |
Dean Academics, Professor and Head |
| Affiliation |
SRM Dental College and Hospital |
| Address |
Department of Oral Pathology
SRM Dental College & Hospital
Bharathi Salai
Ramapuram
Chennai 600089
Tamil Nadu
India
Chennai
TAMIL NADU
600089
India |
| Phone |
9500058376 |
| Fax |
|
| Email |
dean.acad@dental.srmrmp.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Elavenil Panneerselvam |
| Designation |
Professor |
| Affiliation |
SRM Dental College and Hospital |
| Address |
Department of Oral & Maxillofacial Surgery
SRM Dental College & Hospital
Ramapuram
Chennai 600089
Tamil Nadu
India
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenip@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Dental College and Hospital
Bharathi Salai
Chennai 600089 |
|
|
Primary Sponsor
|
| Name |
Elavenil Panneerselvam |
| Address |
Professor
Department of Oral and Maxillofacial Surgery
SRM Dental College and Hospital
Bharathi Salai
Chennai 600089
Tamilnadu |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Elavenil Panneerselvam |
SRM Dental College and Hospital |
Department of oral and maxillofacial surgery, Ground floor, Bharathi Salai, Ramapuram,
Chennai – 600089, Tamil Nadu
India
Chennai
TAMIL NADU |
9841254653
elavenip@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONTROL GROUP
Patients with Alcohol Use Disorder requiring surgery for facial fracture |
Comparator agent - None
(No alcohol in the postoperative period - alcohol abstinence) |
| Intervention |
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 body wt /day) 1.4ml of alcohol/kg/day for 7days (1st week) followed by 0.7ml of alcohol/kg/day for
7days (2nd week)
Route of administration - oral
Time - 10 to 11 am ( Postoperative day 1 to 7) and 6 to 7 pm (Postoperative day 8 to 14)
Monitoring of alcohol levels by using breath analyzer and biochemical test (CDT - Carbohydrate Deficient Transferrin) |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
-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 |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To evaluate peri operative stress levels 2. To evaluate quality of life |
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 Outcome
|
| Outcome |
TimePoints |
3. To evaluate soft tissue healing
4. To evaluate fracture healing
4.a biochemical evaluation
4.b Imaging |
3. 7th, 14th and 21st postoperative days
4.a Preoperative and 30th postoperative day
4.b Preoperative, 4th and 8th week postoperatively |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Most patients who sustain facial trauma have a history of alcohol use disorder (AUD) 60%. Conventional treatment protocols dictate complete abstinence from alcohol in the peri operative period (before & after surgery) because of potential adverse effects associated with alcoholism such as anaesthetic complications and healing. However, alcohol abstinence leads to emotional and psychological disturbances in the peri-operative period in the form of suicidal tendencies, aggressive behaviour and post traumatic stress disorder, which affect the immediate family members and the society. Guidelines to manage these patients in an acute trauma setting is missing. Earlier studies recommending alcohol as treatment in the peri operative period ; Ungur et al 2020, , Spies 2006 , Eggers et al 2002 , Merry in Lancet 1972. This study is a randomized, outcome assessor blind, parallel group active controlled trial to study the effect of supervised administration of therapeutic alcohol on Quality of Life (QoL), stress and healing in patients with alcoholic history undergoing surgery for facial fractures that will be conducted in SRM dental college and hospital, Chennai, India. The primary outcome measures will be to evaluate peri-operative stress levels and quality of life. The secondary outcomes were to evaluate soft tissue and fracture healing. The investigating team includes maxillofacial surgeon, psychiatrist, anesthetist, gastroenterologist and member of alcohol anonymous group. |