| CTRI Number |
CTRI/2024/11/076853 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of oxygen level in blood for confirmation of successful block after giving infraclavicular block in patients undergoing upper limb surgery
|
|
Scientific Title of Study
|
Assessment of perfusion index as a predictor of successful block following infraclavicular block in patients undergoing upper limb surgery
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
GGS Medical college and Hospital , Faridkot , Punjab |
| Address |
Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab
151203
India
Faridkot PUNJAB 151203 India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
GGS Medical college and Hospital , Faridkot , Punjab |
| Address |
Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab
151203
India
Faridkot PUNJAB 151203 India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Harlab Singh |
| Designation |
Junior Resident |
| Affiliation |
GGS Medical college and Hospital , Faridkot , Punjab |
| Address |
Department of Anaesthesia , GGS Medical college and hospital , Faridkot ,Punjab
151203
India
Faridkot PUNJAB 151203 India |
| Phone |
9876585426 |
| Fax |
|
| Email |
Harlabsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthisiology , GGS Medical college and Hospital , Faridkot , Punjab , India ,
Pincode 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Haramritpal Kaur |
| Address |
Professor , Department of Anaesthesiology,
GGS Medical College and Hospital, Faridkot , Punjab , India , Pincode 151203
|
| Type of Sponsor |
Government medical college |
|
|
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 Harlab Singh |
GGS medical college and Hospital , Faridkot |
Department of Anesthesia , GGS Medical college and hospital , Faridkot ,Punjab
151203
India Faridkot PUNJAB |
09876585426
Harlabsingh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of GGS medical college and Hospital , Faridkot ,Punjab , India , Dr Haramritpal kaur and Dr Gagandeep (Mentioned in upper part of document) are the PI for the EC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists Grade I and II patients posted for elective upper limb surgeries under infraclavicular block. |
|
| ExclusionCriteria |
| Details |
History of anaphylaxis or allergy to the study drugs and patients having hepatic, renal or cardiovascular dysfunction , skin or soft tissue infection at site of needle entry or having coagulopathy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study perfusion index as a predictor of successful infraclavicular block in patients undergoing upper limb surgeries |
Perfusion Index will be assessed at baseline then every two minutes for ten minutes and every five minutes till thirty minutes following infraclavicular block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare change in perfusion index in operative & non operative limb |
Perfusion Index will be assessed at baseline then every two minutes for ten minutes & every five minutes till thirty minutes following infraclavicular block |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
02/12/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The infraclavicular block is a brachial plexus block used as an alternative or adjunct to general anesthesia. It can be used for postoperative pain control for upper extremity surgeries such as the elbow, forearm, and hand. The infraclavicular block is a regional anesthetic technique developed to avoid the side effects and complications of supraclavicular blocks, particularly pneumothorax.
The success of peripheral nerve blocks is usually assessed by sensory and motor function. But this method is subjective, time consuming and cannot be done in patients under deep sedation or otherwise unable to provide feedback. Various objective methods like thermographic temperature measurement, laser doppler perfusion imaging and skin electrical resistance have been developed. These methods depend on evaluation of sympathetic block and consequent physiological changes such as vasodilation, change in blood flow and skin temperature . However, most of these objective methods require sophisticated and expensive equipment.
Perfusion index (PI) is a simple, objective and non-invasive method for evaluation of the success of central neuraxial and peripheral nerve blocks. It has been shown to be useful measure to evaluate various peripheral nerve blocks. It is calculated by dividing the ratio of arterial blood flow (pulsatile) to venous, capillary, and tissue blood flow (non-pulsatile blood flow) and is shown as a percentage or absolute value. Perfusion index has been shown to help clinicians predict illness severity and early adverse respiratory outcomes in neonates, predict low superior vena cava flow in very low birth weight infants, provide an early indicator of sympathectomy after epidural anesthesia, and improve detection of critical congenital heart disease in newborn. As very few studies are available in literature for PI as an indicator for evaluating the success of peripheral nerve blocks. In present study we planned to evaluate the perfusion index as the predictor of successful block in patients undergoing upper limb surgeries under ultrasound guided infraclavicular block.
This study will include 60 patients of either sex planning to undergo upper limb surgeries under ultrasound-guided infraclavicular nerve block. After local anesthetic injection, sensory and motor block success will be assessed and perfusion index will be recorded at baseline and at every 2 minutes till 10 minutes and every 5 minutes thereafter till 30 min. The PI ratio will be calculated as the PI after 10 min divided by the PI at the baseline. The observation obtained will be tabulated and analyzed using appropriate statistical method. |