| CTRI Number |
CTRI/2024/12/078133 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see the success rate of radia artery cannulation after blocking median nerve in old age patients with the help of ultrasound |
|
Scientific Title of Study
|
Effect of median nerve block on the success rate of ultrasound guided radial artery cannulation in elderly patients, 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 |
DENADHAYALAN N |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical care, AIIMS Jodhpur, Bassi Industrial Area Phase 2, Jodhpur- 342005, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8883739523 |
| Fax |
|
| Email |
denadhayalan26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ANKUR SHARMA |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical care, AIIMS Jodhpur, Basni Industrial Area Phase 2, Jodhpur -342005, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9654045653 |
| Fax |
|
| Email |
ankuranaesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DENADHAYALAN |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Jodhpur |
| Address |
Department of Anaesthesiology and Critical care, AIIMS Jodhpur, Bassi Industrial Area Phase 2, Jodhpur- 342005, Rajasthan
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8883739523 |
| Fax |
|
| Email |
denadhayalan26@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences(AIIMS), JODHPUR |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS Jodhpur |
| Address |
Basni Industrial Area Phase 2, Jodhpur, Rajasthan, India - 342005 |
| 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 |
| Dr DENADHAYALAN |
All India Institute of Medical Sciences Jodhpur |
Department of Anaesthesiology and Critical Care,3rd floor, D n T block, AIIMS Jodhpur, Basni Industrial Area Phase 2 , Jodhpur- 342005
Jodhpur
RAJASTHAN |
8883739523
denadhayalan26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS JODHPUR |
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 |
| Intervention |
Median Nerve block |
Single shot of 5ml of 0.5% lidocaine will be injected for median nerve block under ultrasound guidance in the middle of forearm with forearm in supine position using 22G stimuplex needle. |
| Comparator Agent |
Without Median Nerve Block |
Patients for whom intra arterial line is taken under ultrasound guidance without median nerve block. Procedure starts with the beginning of ultrasound scanning in both groups and ends when arterial free backlog is achieved. It is considered as technique failure if not able to cannulate in 3 attempts. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients (65 years or above) undergoing major surgeries where intra arterial line is required for continuous BP monitoring/arterial blood sampling. |
|
| ExclusionCriteria |
| Details |
Signs of skin infection or a wound near puncture site .
Abnormal circulation of the hand that is Allens test positive .
Lignocaine allergy .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Success rate of cannulation in first attempt. |
At baseline(intra operative period) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Radial artery diameter before & 10 minutes after the block.
Time taken for cannulation.
Total number of attempts made.
Complications related to procedure (hematoma, bleeding, thrombosis)
|
At baseline (intra operative period) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
An attending anaesthesiologist would examine the patient during the preoperative visit one day prior to surgery. Informed and written consent for participation in the study will be taken in the preoperative period.
In preoperative area,all baseline vitals will be recorded. Patients will be allocated in two groups , intervention group M and control group C by computer generated algorithm. The group allocation number will be concealed in sealed opaque envelopes and a staff member not involved with the patient at any time will open the sealed envelope.
All standard ASA monitoring will be attached to the patient in the operating room. Radial artery diameter will be measured in both the groups under ultrasound guidance before arterial cannulation. All aseptic precautions will be carried out . For the control group C, radial artery cannulation will be attempted under ultrasound guidance. For the intervention group M , median nerve block will be performed under the guidance of ultrasound in the middle of forearm which is placed in supine position using 22G stimuplex needle with 5 ml of 0.5% lidocaine. Radial artery cannulation to done under ultrasound guidance after the block. The procedure is considered a success once arterial back flow is achieved. It is considered as failure if not able to cannulate in 3 attempts. Radial artery diameter 10 minutes after the block, number of attempts, cannulation time and complications related to the procedure will be recorded. Post procedure vitals will be recorded.
|