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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
 
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dilfasharonn@gmail.com].

  6. 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.

  7. 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.
 
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