To assess the role of Virtual Reality as an adjunct to systemic analgesia during rehabilitation in patients undergoing Total Knee Replacement- a prospective randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- 1.Comparison of pain scores during a 30-minute physiotherapy session conducted at two time points: Day 0 (4 hours post-operative) and Day 1 (24 hours post-operative).
研究概览
简要总结
All patients will be admitted either on the day prior to surgery or on the day of surgery. Each patient will undergo a standard pre-anesthetic check-up, which includes clinical examination, laboratory investigations, radiological assessments, and other necessary evaluations. Eligible patients will be counseled regarding participation in the study and provided with detailed information about all modalities of postoperative analgesia, including the use and content streaming capabilities of virtual reality hardware. The counseling session will also include identification of the patient’s area of interest in relation to the content to be streamed through virtual reality during the postoperative period. Patients will be invited to select content of their preference from a predefined menu of available options. Patients will be divided into two groups i.e. study group (group S) and control group (group C) with each n = 106. After obtaining written informed consent from patients, Patients will be taken up to the operation theater after reviewing attached PAC, monitors were attached, venous access secured. Surgery (B/L TKR) will be performed under SAB. Both the groups will receive same drug dose and concentration i.e. Bupivacaine heavy 0.5% 16mg with Fentanyl 25mcg with 26G Quincke needle either at L4-L5 or L3-L4 lumber intervertebral space. All surgeries were performed by same orthopaedic team. After the insertion of the joint prosthesis, peri-articular infiltration of a cocktail of drugs- morphine 10mg, ketorolac 35mg, ropivacaine 0.2% 100ml, and adrenaline 200mcg—was given, divided equally in both knees before closure of the capsule. After the completion of surgery patient will be shifted to orthopaedic ICU for post operative recovery. Rehabilitation exercises will be initiated at modified bromage scale of zero confirming that the motor blockade has weaned off [Table No:-1]. The control group received intravenous injections of paracetamol 1gm, every 6th hourly, diclofenac 75mg 12th hourly, and tramadol 100mg 8th hourly. The study group will receive same analgesics, but as per need after application of VR.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •Patient planned to undergo B/L TKR for degenerative OA.
- •Age above 18 years Both male and female Orientation, comprehension, communication of certain level based on a certain screening questionnaire.
排除标准
- •H/O Vision problem (Hypermetropia) H/O Hearing problem (SNHL) H/O Recurrent headache Refusal (Non consenting).
- •H/O Migraine that precipitated with glaring lights.
- ••Complaining of headache, dizziness on a 15 min trial of VR.
- ••Patient who have been given PNB and epidural analgesia (central nerve block) for post operative analgesia.
结局指标
主要结局
1.Comparison of pain scores during a 30-minute physiotherapy session conducted at two time points: Day 0 (4 hours post-operative) and Day 1 (24 hours post-operative).
时间窗: At Day2
2.Difference in range of motion at joint on Day 0, Day 1.
时间窗: At Day2
次要结局
- 1.Maximum range achieved at discharge or Day 2 (if discharged late).(2.Requirement of systemic analgesics during the duration of rehabilitation.)
研究者
Rajiv Dhunna
IVY HEALTH AND LIFE SCIENCES
