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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 1. To evaluate peri operative stress levels 2. To evaluate quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 21.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. To evaluate peri operative stress levels 2. To evaluate quality of life
时间窗: 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
次要结局
- 3. To evaluate soft tissue healing(4. To evaluate fracture healing)
研究者
Elavenil Panneerselvam
SRM Dental College and Hospital