A Trial Comparing Pain During Local Tumesent Injection In Fingers Using Different Syringe-Needle Combinations
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain measured using Visual Analagoue Scale (VAS)
研究概览
简要总结
Background: This study aims to obtain the most favorable syringe and needle combination, which causes the least pain during local anesthesia tumescent injection in the simulation of fully awake hand surgery.
Methods: A randomized single-blinded controlled trial is designed for 30 adult male healthy subjects to compare the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. The injection will be SIMPLE block technique using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc. Subjects are required to rate two check-point of VAS at the timing of needle puncture and just right after the completion of the infiltration. Upon the completion of each finger, the subject is also asked to give response to seri of questions regarding the procedures and their preferences. At the end of all injections, subject is asked to rate his preference of syringe and needle combination.
详细描述
METHODS
3.1 DESIGN This is a randomized, single-blinded controlled trial to measure local pain following local anesthesia tumescent injection using a different combination of syringe and needle in a healthy volunteer.
3.2 TIME AND PLACE The study will be conducted at Cipto Mangunkusumo Hospital (RSCM) in February to March 2018
3.3 SAMPLE 30 male healthy subjects (aged 18-60 years) who volunteer to join this study and meet the inclusion criteria are going to be selected with the convenient sampling method
3.4 SAMPLE SIZE Sample size for pilot study are used. The expected sample size is between 10-40 per groups, therefore we choose 30 subjects (90 fingers tested) to be included into 3 different treatment group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The senior author (T.O.H.P) will perform all injection, and are given three pieces of paper before ever injection, to silently give information on tumescent technique, fingers sequence, syringe-needle combinations sequence and the solution used. Subjects are seated comfortably, behind a screen with a small opening large enough to introduce the tested hand. Both hands are placed on the supine position on the table. Seating positions and hand positions are designed somewhat ergonomics and comfort, to avoid creating bias due to positional discomfort. They could not see any of the procedure and won't know which syringe-needle combinations is used.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy in general
- •aged 18 to 60 years old
排除标准
- •history of blood or coagulation disorder
- •history of neuro vasculopathy
- •history of liver and renal disease
- •currently active smoker or already stopped less than 1 month
- •had previous injury or surgery in hand
- •hand scar detected
- •history of Raynaud's phenomenon
- •history of vasospastic disorders
- •history of scleroderma
- •history of Buerger's disease
- •history of Dupuytren's disease
- •history of complex regional pain syndrome.
研究组 & 干预措施
1 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Injection using 1 cc of NaCl 0.9% (Procedure)
1 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Patient Preference Question (Other)
1 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Questionnaires (Other)
3 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Injection using 1 cc of NaCl 0.9% (Procedure)
3 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Patient Preference Question (Other)
3 cc syringe with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Questionnaires (Other)
5 cc needle with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Injection using 1 cc of NaCl 0.9% (Procedure)
5 cc needle with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Patient Preference Question (Other)
5 cc needle with 26 G needle
comparing the pain from injection using syringe and needle combination i.e. 1) 1 cc syringe with 26G needle, 2) 3 cc syringe with 26 G needle, and 3) 5 cc needle with 26 G needle. The injection will be performed in any of at the second, third and fourth fingers of either subject's hand randomly. Injection using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
干预措施: Questionnaires (Other)
结局指标
主要结局
Pain measured using Visual Analagoue Scale (VAS)
时间窗: VAS will be assessed at 3 check point: 1.Initial needle prick, 2.initial infiltration of tumescent injection and 3. after the infiltration finished
VAS is usually a horizontal line using a 10 cm baseline, anchored by word descriptors at each end. The client is asked to mark a point on a continous line corresponding to the severity of their pain (from the left-end to right end range is from "no pain" to "pain as bad as it could possibly be")
次要结局
- Patient questionnaire responses(Right after all injection sequence performed in one finger (approximately 10 seconds after the injection))
- Patient preference questionnaire(Right after all injection performed (approximately 50 seconds after all injection finished))