Efficacy of Infra orbital nerve block in BMG urethroplasty.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- dribbling of saliva
研究概览
简要总结
The primary purpose of the study was to
evaluate the efficacy of infraorbital nerve block (IOB)in relieving pain at the donor site of the buccal mucosal graft and its assosciated morbidity.
Methods : 28 adults scheduled for buccal mucosal graft urethroplasty were enrolled in this study were randomized into two groups by computer generated random numbers. All patients received standard general anesthesia with nasotracheal intubation. All patients received epidural analgesia with 0.25% bupivacaine intra and postoperatively for 48hrs.
Group- I (14 pts) received no IOB and is the control. Group –II (14pts) received block intra-orally twice with 1ml of 0.5% bupivacaine one after intubation and second after completion of surgery to avoid bias of surgical duration and is the study group. Pain was assessed by visual analogue score, intra oral morbidity, patient satisfaction, chronic oral pain were noted in two groups. If the pain score exceeded 4 rescue analgesia inj tramadol was administered intramuscularly. All Patients were followed up after 1 and 6 months for chronic morbidity like perioral numbness and tightness on opening mouth and any other problems if any.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Male
入选标准
- •All patients with stricture urethra for BMG urethroplasty Age 18-60 ASA I and II.
排除标准
- •Exclusion Criteria: Patients with local infection at the site of injection of nerve block history suggestive of drug allergy, any systemic disease that compromise any cardiovascular, respiratory and neurological function, coagulation disorders, visible submucosal fibrotic changes of buccal mucosa .
结局指标
主要结局
dribbling of saliva
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
patient satisfaction
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
Long term morbidity at 1 month
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
Pain at the donor site of buccal mucosa
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
tightness in mouth opening
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
numbness
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
Time to take oral diet both liquid and solids
时间窗: pain scores at every 4hhrs and time to oral liquid and solids every 24hrs and after 30 daysnsatisfaction and long term morbidity morbidity
次要结局
- patient satisfaction(one month)