| CTRI Number |
CTRI/2021/01/030291 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
29/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of quality of pain relief provided by injecting drugs that numb pain through a thin tube placed around the nerve supplying leg and foot for wound dressing in the hospital ward |
|
Scientific Title of Study
|
Effectiveness of analgesia through subparaneural sciatic nerve catheter for wound management in the wards - A descriptive study |
| 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 Inan M |
| Designation |
Postgraduate student |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second floor, Hospital block
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8939183566 |
| Fax |
|
| Email |
inan2203@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charulatha R |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second floor, Hospital block
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charulatha R |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Second floor, Hospital block
Mahatma Gandhi Medical College and Research Institute
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9894909652 |
| Fax |
|
| Email |
ravindrancharulatha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Medical College and Research Institute
Pillayarkuppam
Pondicherry -607403 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Medical College and Research Institute |
| Address |
Pillayarkuppam
Pondicherry - 607403 |
| Type of Sponsor |
Private 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 Inan M |
Mahatma Gandhi Medical College and Research Institute |
Department of Anaesthesiology
Second Floor
Hospital Block
Mahatma Gandhi Medical College and Research Institute
Pillayarkuppam
Pondicherry - 607403
Pondicherry
PONDICHERRY |
8939183566
inan2203@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
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 |
Nil |
Nil |
| Intervention |
Sciatic nerve catheter inserted for wound management in the hospital ward |
Sciatic nerve catheter will be placed in the sub paraneural compartment of the sciatic nerve above popliteal fossa for injecting local anaesthetic during wound dressing in the ward. The dose of local anaesthetic used would be 20 ml of 1.0 % lignocaine without adrenaline. Frequency of administration would be 30 minutes prior to dressing through the sciatic nerve catheter. The catheter will be removed when the pain score during dressing is less than 3 without local anaesthetic administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with wound in the lower limb below the knee
2. American Society of Anaesthesiologists Physical status classification 1 - 4
|
|
| ExclusionCriteria |
| Details |
1. Patients with wound predominanty in the saphenous component of the leg
2. Coagulopathy
3. Local infection at the catheter infection site |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain assessment by Verbal Numeric Rating Scale during wound dressing |
After 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Degree of the sensory block |
At 30 minutes |
| Degree of motor block |
At 30 minutes |
| Duration of analgesia |
Assessed every second hourly after dressing |
| Duration of sensory motor conduction blockade |
Assessed every second hourly after dressing |
| Incidence of catheter displacement |
Everyday |
| Incidence of catheter leakage |
Everyday |
| Incidence of catheter related local infection |
Everyday |
| Incidence of catheter failure |
Assessed during dressing everyday |
| Rescue analgesic requirement |
Every 24 hours |
| Number of catheter days |
At the time of catheter removal |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/01/2021 |
| Date of Study Completion (India) |
31/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/07/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Data can be obtained by mailing the author at the following email id - ravindrancharulatha@gmail.com
- For how long will this data be available start date provided 02-10-2022 and end date provided 01-10-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After getting written informed consent, patients will be educated about assessment tools used for pain , sensory and motor blockade and sciatic nerve catheter will be placed in the paraneural compartment under ultrasound guidance. The position of the catheter will be checked and patient will be shifted to ward. Thirty minutes prior to dressing, local anaesthetic solution will be injected through the catheter and degree of sensory and motor blockade will be assessed. After 30 minutes, wound dressing or debridement will be done in the ward treatment room. During the procedure, degree of analgesia will be assessed on a verbal numeric rating scale. After the end of the procedure, the recovery of sensory and motor conduction and duration of analgesia will be assessed at regular intervals. Catheter will be inspected everyday and if any signs of infection are found, catheter will be removed. Catheter will be retained until necessary based on wound healing and then removed.
|