Effect of Different Concentrations of Lidocaine in Relieving Pain in Wide Awake Hand Surgery Using Tumescence

Study Overview
=================
Brief Summary
-----------------
Lidocaine has been used along with adrenaline in tumescent anesthesia for a variety of procedures. This has been quite popular especially in wide awake surgery of the hand with no tourniquet. However, the appropriate lidocaine concentration is yet to be established. This randomized control trial will study the minimum effective lidocaine concentration in hand surgery using the tumescent technique.

Official Title
-----------------
Effect of Different Concentrations of Lidocaine in Relieving Pain Peroperatively and 24 Hours Postoperatively in Wide Awake Hand Surgery Using Tumescent Local Anesthesia Technique

Conditions
-----------------
Lidocaine

Intervention / Treatment
-----------------
* Drug: lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 16 to 60 years of either gender Patients with post burn/post traumatic contractures involving fingers & palm Patients with nerve injury or flexor/extensor tendons injury distal to mid forearm. Exclusion Criteria: Patients with history of ischemic heart disease, chronic liver disease (ALT/AST 40 IU/L), renal disease (creatinine 13mg/dl), bleeding disorder, peripheral arterial disease & peripheral neuro3pathy . Surgical site infection . History of allergic hypersensitivity to epinephrine or lidocaine.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.1% lidocaine<br> | Drug: lidocaine<br>* different concentrations of lidocaine with same concentration of adrenaline<br>* Other names: adrenaline;|
| Experimental: 0.2% lidocaine<br> | Drug: lidocaine<br>* different concentrations of lidocaine with same concentration of adrenaline<br>* Other names: adrenaline;|
| Experimental: 0.3% lidocaine<br> | Drug: lidocaine<br>* different concentrations of lidocaine with same concentration of adrenaline<br>* Other names: adrenaline;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total duration of analgesia | Patients were randomized to either 0.1percent, 0.2 percent and 0.3 percent groups. Tumescent local anesthesia was infiltered. Surgery was started approximately 25 minutes after the infiltration. Start of surgery was designated 0 minute. Duration of pain free surgery was noted in minutes. Pain scores was measured after surgery. When pain scores was equal to or more than 4, analgesia was given and total time in minute from start of surgery till this time was taken as total duration of analgesia. | Within 24 hours of randomization. |