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CTRI Number  CTRI/2023/07/055331 [Registered on: 18/07/2023] Trial Registered Prospectively
Last Modified On: 07/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of continuous injection of pain relief medication around nerves after amputations of the leg 
Scientific Title of Study   Effect of Perineural Bupivacaine Infusion on Postoperative Opioid Requirement After Major Lower Limb Amputation: An Open-label Randomized Control Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Julia Sunil 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of Surgery, JIPMER, Dhanvatri Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  6374067368  
Fax    
Email  juliasunil96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abhinaya Reddy 
Designation  Assistant Professor 
Affiliation  JIPMER 
Address  Department of Surgery, JIPMER, Dhanvantri Nagar

Pondicherry
PONDICHERRY
606006
India 
Phone  8195014433  
Fax    
Email  reddy.kmc2k6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Julia Sunil 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  Department of Surgery, JIPMER, Dhanvantri Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  6374067368  
Fax    
Email  juliasunil96@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural fund 
 
Primary Sponsor  
Name  JIPMER Intramural fund 
Address  JIPMER, Jipmer Campus Rd, Jipmer Campus, Dhanvantari Nagar, Puducherry, 605006 
Type of Sponsor  Government 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 
Julia Sunil  JIPMER hospital  Department of Surgery, Wards 31,34,35,36,37, special wards, trauma wards, JIPMER, Jipmer Campus Rd, Jipmer Campus, Dhanvantari Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY 		 6374067368

juliasunil96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Interventional Studies (JIPMER)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, (2) ICD-10 Condition: I739||Peripheral vascular disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Perineural Bupivacaine infusion after major lower limb amputation  Perineural catheter will be placed intra-op during major lower limb amputation and bupivacaine infusion administered for 72h post-op 
Comparator Agent  standard amputation techniques and anaesthesia protocols.   Patients in the control group will be managed with standard amputation techniques and anaesthesia protocols such as pain management with opioids and NSAIDS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Adult patients (Age ≥ 18 years) undergoing elective or emergency major lower limb amputations 
 
ExclusionCriteria 
Details  1.Patients undergoing hip disarticulation, and hindquarter amputation.

2.Patients who have an allergy to bupivacaine

3.Patients are expected to be requiring sedation or ventilatory support for more than 24 hours.

4.Patients undergoing revision amputation who have been previously recruited into the study.

5.Patients undergoing bilateral amputations.

6.Patients in whom the appropriate nerve could not be identified.

7.Patients undergoing Guillotine amputation.

8.Patient denying consent
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care  Measured every 6h for 72h  
 
Secondary Outcome  
Outcome  TimePoints 
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups.
 		 3 days 
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of catheter-related complications (brocade, slippage, wound infections).
 		 duration of hospital stay 
To determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for incidence of Phantom limb pain  3 months post op 
 
Target Sample Size   Total Sample Size="124"
Sample Size from India="124" 
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)   18/07/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a clinical, prospective, randomised, open label, controlled trial in which the primary objective is to determine the decrease in patient’s post-operative opioid requirement in those undergoing major lower limb amputation and receiving continuous perineural infusion of bupivacaine for three days compared to those receiving standard care. Secondary objectives are to determine and compare the postoperative continuous perineural infusion of Bupivacaine and standard management after major lower limb amputation for postoperative mean pain score assessed using the visual analog scale (VAS) for three days in both groups, incidence of catheter-related complications (brocade, slippage, wound infections), and incidence of Phantom limb pain.

A sample size of 124 is aimed for and recruited patients undergoing major lower limb amputations will be randomised into the control and study groups intra op after identification of the nerve around which perineural catheter is to be placed. Patients in the control group will recieve bupivacaine infusion for 72h post op via the perineural catheter and post op opioid requirements will be assessed for 72h post op. Secondary outcomes will also be assessed. Patients in the control group will be managed according to standard amputation techniques and anaesthesia protocols.
 
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