Comparison of analgesic effect of Wide-Awake Local Anaesthesia No Tourniquet (WALANT) technique and regional anaesthesia with tourniquet in hand surgery: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To compare post-operative pain scores every 6 hourly up to first 24 hours among the two
研究概览
简要总结
TITLE:
Comparison of analgesic effect of wide awake local anaesthesia
no tourniquet (WALANT) technique and regional
anaesthesia with tourniquet in hand surgery: A randomised control trial.
AIMS AND OBJECTIVES:
To compare intra-operative and post-operative analgesic efficacy, analgesic
requirements and complications between patients undergoing hand surgeries using either
WALANT technique or Brachial plexus block with tourniquet technique.
Primary objective:
To compare post-operative pain scores every 6 hourly up to first 24 hours among the two
groups using the Numerical Rating Scale (NRS)
Secondary objective:
-
To compare Intra-operative pain scores using NRS scale at every 1 hour time point
-
To compare intra operative blood loss
-
To compare Total surgical time between the two groups
-
To compare Total anaesthesia time between the two groups
-
To compare Quality of surgical field
-
To compare post operative analgesic consumption including opioid consumption.
-
To compare Post operative Adverse effects- incidence of tourniquet pain, digital necrosis,
residual weakness
METHEDOLOGY:
Patients meeting inclusion criteria posted for surgery in plastic surgery OT or ATC OT will
be assessed by the surgeons. Patients will be evaluated before surgery to assess their fitness
for the proposed surgical procedure, and written informed consent will be obtained at this14
stage. Patients will be instructed on the pain Numerical Rating Score before surgery, and will
be reminded before transfer to the operating theatre and in the post- anaesthesia care unit. All
patients will be fasted as per ASA guidelines .
In the operating theatre, ASA mandatory monitoring including NIBP (Non-Invasive Blood
Pressure), heart rate, continuous ECG, oxygen saturation and end-tidal carbon
dioxide will be placed. Intravenous access will be established and patients will receive 500
ml 0.9% normal saline. Depending on the group allocation the patient will be given allocated
mode of anaesthesia.
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults≥18 years old.
- •Clinical diagnosis of acute flexor tendon injury at wrist and hand (zone 1-5) injury within 2 weeks of injury.
- •Carpal tunnel, Duptyren’s contracture release
- •The patient understands and is willing to participate and can comply with the follow- up regime.
排除标准
- •Tendon not amendable to primary repair (gross wound contamination, segmental tendon loss, associated fractures or mangled hand injuries).
- •Secondary tendon repair or reconstruction.
- •History of allergy to Local Anaesthetic (LA).
- •Refusal to have LA or deemed non-cooperative to be performed without sedation.
- •Pre-existing deformity of finger or hand.
结局指标
主要结局
To compare post-operative pain scores every 6 hourly up to first 24 hours among the two
时间窗: baseline, 6 hours, 12 hours, 24 hours
groups using the Numerical Rating Scale (NRS)
时间窗: baseline, 6 hours, 12 hours, 24 hours
次要结局
- 1. To compare Intra-operative pain scores using NRS scale at every 1 hour time point(2. To compare intra operative blood loss)
研究者
Deepika Attri
PGIMER