Fascia Iliaca Compartment Block (FICB) for skin donor site pain: Comparative study of 50 patients
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- DMC
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post operative pain releif
研究概览
简要总结
Background
Thigh is the commonest site for harvesting the skin graft. Almost all patients have varying degree of pain for 3 to 4 days after the procedure. In some patients pain persists even after giving oral analgesics which hamper their routine activities
Aims
To compare skin graft donor site pain relief using continuous FICB with 0.125% bupivacaine with those who will receive a placebo infusion of 0.9% normal saline. Patient satisfaction score at the end of study will also be noted
Methods
IEC clearance will be taken. Informed written consent from patients will be obtained. Standardized SA technique using 2ml of 0.5% bupivacine will be used in all patients. Patients will be randomly assigned to the FICB or placebo block groups of 25 each.
After giving SA, under all aseptic precautions, using landmark guided Fascia iliaca compartment catheter will be introduced on the thigh from which skin graft is to be taken, catheter will be fixed and surgery will be allowed .
In the postoperative period, as soon as patient complains of pain more than VAS 4, they will be given the intervention drugs according to the group to which that patient belongs as follows:
In Group I, patient will be given 0.8ml/Kg body weight of 0.25% bupivacine bolus in FICB catheter followed by a continuous infusion of 0.125% bupivacine at the rate of 10ml/hour for next 72 hours through FICB catheter.
In Group II, patient will be given 0.8ml/Kg body weight of 0.9% normal saline bolus in FICB catheter followed by a continuous infusion of 0.9 of normal saline at the rate of 10ml/hour for next 72 hours through FICB catheter.
Postoperative pain will be assessed using VAS at 2 h, 4 h, 6 h, 12 h, 24 h, 36h, 48 h, 60h and 72h after FICB continuous infusion is started.
Any patient complaining VAS greater than or equal to 4 or at any point of time or when patient complains of pain will be administered rescue analgesic in the form of intravenous injection Tramadol 50 mg and time of first rescue analgesic request will be noted. If the patient still reports VAS greater than 4 after 30 minutes of receiving Tramadol, similar dose will be repeated up to a maximum of 100 mg in contiguous 4 hours or 400 mg in 24 hours. any patient complaining of pain even after giving injection Tramadol according to the protocol, will be given second rescue analgesic of injection diclofenac sodium 75mg diluted in 10 ml saline, slow intravenously over 5 minutes and will not be repeated earlier than 8 hours of first injection with a total of three injections in 24 hours. Total doses of first and second rescue analgesic consumed in 72 hours after continuous infusion analgesia is started will also be recorded.
FICB catheter will be removed 72 hours after analgesic infusion is started and study period will end. Any pain persisting 72 hours after analgesia is started will be treated as per department protocol. Patients pain relief satisfaction score will be recorded 1 hour after the FICB infusion is stopped as:
Excellent (4), Good (3), Moderate (2), Poor (1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients in whom skin graft is taken from lateral or anterior part of one thigh only.
排除标准
- •Patients refusal Anticoagulation Previous femoral bypass surgery Inflammation / infection at the site of injection Allergy to any drugs which will be used.
结局指标
主要结局
Post operative pain releif
时间窗: Post operative pain releif
次要结局
- Patients pain relief satisfaction score will be recorded(1 hour after the FICB infusion is stopped)
