| 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
|
|
|
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
|
|
|
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. |