| CTRI Number |
CTRI/2022/09/045694 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Nerve blocks to provide pain relief for finger injury: A retrospective study. |
|
Scientific Title of Study
|
Nerve blocks to provide procedural analgesia for finger injury: A retrospective study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Neha Singh |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Bhubaneswar |
| Address |
Department of Anesthesiology and Critical care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha, India
Khordha
ORISSA
751019
India
Khordha
ORISSA
751019
India |
| Phone |
9438884045 |
| Fax |
|
| Email |
anaes_neha@aiimsbhubaneswar.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar, Odisha India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Sijua Patrapada Bhubaneswar Odisha India |
| Address |
All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India |
| 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 Neha Singh |
Procedure Room, Emergency Department, All India Institute of Medical Sciences, Bhubaneswar |
Trauma and Emenrgency, AIIMS, Bhubaneswar, Khordha ORISSA
Khordha
ORISSA
Khordha
ORISSA |
9438884045
anaes_neha@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S699||Unspecified injury of wrist, handand finger(s), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL (observational study) |
| Intervention |
NIL |
NIL (observational study) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, age more than 18 years with injuries to one or more fingers in the upper limb, who received nerve block for procedural analgesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with known allergies to local anesthetic agents.
2. Complete data not available
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia after the blocks |
Analgesia Duration at 30 min, 60 min and total duration of analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Motor Blockade
at 30 min, 60 min and total duration of motor blockade. |
at 30 min, 4 hours and total dduration of motor block |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/09/2022 |
| Date of Study Completion (India) |
10/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none for now |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After approval from Institutional ethics committee, the data of the adult patients who received either DNBs or SPNBs for procedural analgesia from the February 2022 to July 2022 will be checked. They will be assigned to the two groups based on the intervention used for PA. Only demographic details, injury details, type of block used, drug administered, sensory and motor effects, duration of analgesia will be noted from the records for the analysis further. Patient’s identity will not be disclosed and the confidentiality will be maintained at all the time. |