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CTRI Number  CTRI/2024/05/066922 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To campare the analgesic effect of Wide-Awake Local Anaesthesia No Tourniquet technique (WALANT) with regional anaesthesia with tourniquet in hand surgeries. 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepika Attri 
Designation  Junior Resident 
Affiliation  PGIMER 
Address  Department of anaesthesia and intensive care, level 3 Nehru hospital, PGIMER
Department of anaesthesia and intensive care, level 3 Nehru hospital, PGIMER
Chandigarh
CHANDIGARH
160012
India 
Phone  7006086561  
Fax    
Email  dupad.atri@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karan Singla 
Designation  Assistant professor  
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER

Chandigarh
CHANDIGARH
160012
India 
Phone  9592919073  
Fax    
Email  karansingla16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karan Singla 
Designation  Assistant professor  
Affiliation  PGIMER 
Address  Department of Anaesthesia and Intensive Care, PGIMER


CHANDIGARH
160012
India 
Phone  9592919073  
Fax    
Email  karansingla16@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesia and intensive care, PGIMER, Chandigarh, India 160012 
 
Primary Sponsor  
Name  Deepika Attri 
Address  Department of anaesthesia and intensive care, level 3 Nehru hospital, PGIMER 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepika Attri  Postgraduate Institute of Medical Education and Research (PGIMER), sector 12, chandigarh  Advanced Trauma Centre, Second floor, Operation theatre complex,
Chandigarh
CHANDIGARH 
7006086561

dupad.atri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, PGIMER, Chandigarh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Brachial plexus block   comparator group will undergo brachial plexus blocks using infraclavicular, supraclavicular and axillary approches for hand surgeries. 
Intervention  WALANT (wide-awake local anaesthetic no tourniquet)  A WALANT solution will be prepared by the surgeon using consisting of 50 mL normal saline, 50 mL of 2% lignocaine, 1 mL of adrenaline (1:1000). This solution will be used for infiltration. The patient will be injected in lying down position to avoid occasional vasovagal response. The drug injections would be given inside the operating room 30 minutes prior to surgery. In the finger, the 1% lignocaine with 1:100,000 adrenaline will be injected in the subcutaneous fat in the middle of the base of the phalanges between both digital nerves such that the bevel of the needle does not lacerate the fascicles. In the proximal and middle palmar phalanges, 2 mL of drug will be injected. In the distal phalanx, 1 mL will be injected. The surgeon will inject 10 to 15 mL in the palm wherever dissection will be performed. Total dose of lignocaine with adrenaline will be kept below 7 mg/kg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adults≥18 years old.
2. ASA 1- 3
3. Clinical diagnosis of acute flexor tendon injury at wrist and hand (zone 1-5) injury
within 2 weeks of injury.
4. Carpal tunnel, Duptyren’s contracture release
5. Fixation of phalangeal and metacarpal fracture.
6. The patient understands and is willing to participate and can comply with the follow-
up regime 
 
ExclusionCriteria 
Details  1. Tendon not amendable to primary repair (gross wound contamination, segmental
tendon loss, associated fractures or mangled hand injuries).
2. Secondary tendon repair or reconstruction.
3. History of allergy to Local Anaesthetic (LA).
4. Refusal to have LA or deemed non-cooperative to be performed without sedation.
5. Pre-existing deformity of finger or hand. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare post-operative pain scores every 6 hourly up to first 24 hours among the two
groups using the Numerical Rating Scale (NRS) 
baseline, 6 hours, 12 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare Intra-operative pain scores using NRS scale at every 1 hour time point
2. To compare intra operative blood loss
3. To compare Total surgical time between the two groups
4. To compare Total anesthesia time between the two groups
5. To compare Quality of surgical field
6. To compare post operative analgesic consumption including opiod consumption.
7. To compare Post operative Adverse effects- incidence of torniquet pain, digital necrosis,
residual weakness 
To compare post-operative pain scores every 6 hourly up to first 24 hours among the two
groups using the Numerical Rating Scale (NRS) 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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:

1. To compare Intra-operative pain scores using NRS scale at every 1 hour time point

2. To compare intra operative blood loss

3. To compare Total surgical time between the two groups

4. To compare Total anaesthesia time between the two groups

5. To compare Quality of surgical field

6. To compare post operative analgesic consumption including opioid consumption.

7. 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.

 
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