| CTRI Number |
CTRI/2025/05/086609 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Analgesic Advantage Of Surgically Placed Perineural Catheter For Below Knee Amputation -A Prospective Observational Study |
|
Scientific Title of Study
|
Analgestic advantage of surgical placed perineural catheter for below knee amputation- A prospective observational 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 Dilfa Sharon |
| Designation |
Post-Graduate Registrar, |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesia, Christian Medical College, Vellore – 632004, Tamil Nadu, India
Vellore TAMIL NADU 632004 India |
| Phone |
9790834076 |
| Fax |
|
| Email |
dilfa.j.pg@cmcvellore.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Serina Ruth Salins |
| Designation |
Professor and Head of Unit |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesia, Christian Medical College, Vellore - 632004, Tamil Nadu, India.
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Serina Ruth Salins |
| Designation |
Professor and Head of Unit |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Anaesthesia, Christian Medical College, Vellore - 632004, Tamil Nadu, India.
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian Medical College, Ida Scudder Road,Vellore, Tamilnadu 632003, India |
|
|
Primary Sponsor
|
| Name |
Christian Medical College, Vellore |
| Address |
Christian Medical College, Vellore - 632004, Tamil Nadu, India. |
| 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 Dilfa Sharon |
Christian Medical College, Vellore . |
Department of Anaesthesia, Christian Medical College, Vellore – 632004, Tamil Nadu, India Vellore TAMIL NADU |
09790834076
dilfa.j.pg@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHRISTIAN MEDICAL COLLEGE, VELLORE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, (2) ICD-10 Condition: I738||Other specified peripheral vascular diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ASA-I to III, physical status, aged 18 years or older
2. Patients undergoing elective or emergency major below knee amputation (BKA)
3. Patients capable of assessing pain using a Numerical Rating Scale (NRS) |
|
| ExclusionCriteria |
| Details |
1. Patients with necrotizing fasciitis needing BKA
2. Patients undergoing Above Knee Amputation (AKA) or any other level of amputation (e.g., digital, metatarsal, tarsal, disarticulation of the hip)
2. Patients with an allergy or intolerance to any substances in the perineural catheter (PNC) or local anesthetic agents, or patients chronically taking class IB antiarrhythmic agents or local anesthetic agents in the form of transdermal patches.
3. Patients expected to be managed in the intensive care unit postoperatively and be sedated for more than 24 hours |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study will be the successful placement of perineural catheters in patients undergoing below knee amputation. The catheter will be considered successfully placed if it provides adequate sensory coverage for pain relief and is free from any immediate complications after the procedure. |
Pre-op (Baseline), post-op at 8th hr, 16th hr, 24th hr, 32nd hr, 40th hr,48th hr,56th hr, 64th hr,72nd hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Advantage & Pain Relief: The study will evaluate the analgesic advantage offered by the perineural catheters in providing postoperative pain relief. Pain assessments using standardized scales like the Numerical Rating Scale (NRS) will be conducted at regular intervals to measure pain scores & assess the duration of pain relief achieved with the use of perineural catheters.
Opioid Consumption: The study will also analyse opioid consumption in patients with perineural catheters to evaluate their impact on reducing the need for strong opioids for pain management in the postoperative period.
Overall Patient Outcomes: The study will analyse the overall patient outcomes, including the length of hospital stay, postoperative complications, & functional recovery after below knee amputation, to determine the potential benefits of using perineural catheters in this surgical procedure. |
Pre-op (Baseline), post-op at 8th hr, 16th hr, 24th hr, 32nd hr, 40th hr,48th hr,56th hr, 64th hr,72nd hr. |
|
|
Target Sample Size
|
Total Sample Size="56" Sample Size from India="56"
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)
|
20/05/2025 |
| 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="2" Months="0" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dilfasharonn@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-2045?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Lower-extremity amputation is a critical surgical procedure performed when the tissues of the leg and foot become nonviable or dysfunctional due to various reasons, such as ischemia, infection, trauma, or malignancy. Despite advancements in pain management, postoperative pain after major lower limb amputation remains a significant challenge for both clinicians and patients. The postoperative pain plays a crucial role in determining overall patient satisfaction with their surgical experience.
The use of opioids for pain relief is common, but they come with side effects and potential complications, such as, respiratory depression, pruritus, nausea, vomiting, hemodynamic changesbradycardia, hypotension, to name a few, leading to increased hospital costs and prolonged stay. To improve postoperative pain management, the American Society of Anaesthesiologists(ASA) recommends the use of peripheral wound catheters (PWCs) with local anesthetics. Perineural catheters (PNCs) are a type of PWC specifically placed near major nerves to allow continuous infusion of local anesthetics directly into the perineural space. The study aims to investigate the analgesic advantage of surgically placed PNCs for Below-Knee Amputation (BKA), providing valuable insights into the efficacy and feasibility of this postoperative analgesic technique.
All patients fulfilling the eligible criteria will be recruited into the study after obtaining informed consent on the day before the surgery. PNC will be placed surgically intraoperatively. As per the current protocol, they will be administered intermittent boluses of local anaesthetics (via the catheter), either with an automated bolus pump or manually injections. The postoperative pain assessment will be carried out using the Numerical Rating Scale (NRS) score by the pain team. |