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临床试验/CTRI/2018/03/012524
CTRI/2018/03/012524尚未招募3 期

Fascia Iliaca Compartment Block (FICB) for skin donor site pain: Comparative study of 50 patients

DMC1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月4日最近更新:

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)

研究者

发起方
DMC
申办方类型
Private medical college

研究点 (1)

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