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CTRI Number  CTRI/2024/10/075023 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 05/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Painkiller injection given locally for post-operative pain management after knee ligament surgery 
Scientific Title of Study   Analgesic efficacy of wound infiltration with fentanyl or bupivacaine or bupivacaine with fentanyl in arthroscopic anterior cruciate ligament reconstructive surgery: A double blind randomized control trial 
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 Bhuwan Chand Panday 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar

Central
DELHI
110060
India 
Phone  9999200881  
Fax    
Email  bhuwancp@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shamly Jindal 
Designation  DNB Trainee 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar

Central
DELHI
110060
India 
Phone  8222888868  
Fax    
Email  Simplyfab19.1994@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Bhuwan Chand Panday 
Designation  Senior Consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  Room no.10 SSRB BUILDING 5th floor Institute of anaesthesiology, pain and perioperative medicine, SGRH, rajinder nagar


DELHI
110060
India 
Phone  9999200881  
Fax    
Email  bhuwancp@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital,New Delhi 
Address  Rajinder nagar,New delhi,110060 
Type of Sponsor  Research institution and hospital 
 
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 Bhuwan Chand Panday  Ot complex  6th and 7th floor SSRB BUILDING Sir Ganga Ram Hospital, Rajinder Nagar, New Delhi
Central
DELHI 
9999200881

bhuwancp@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee, Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group B- Bupivacaine 0.25%   Group B: Surgical site will be infiltrated with 10 ml of 0.25% bupivacaine hydrochloride. 
Intervention  Group BF - Bupivacaine Fentanyl  Group BF - Bupivacaine 0.25%+ Fentanyl 50 microgram in 10ml saline 
Intervention  Group F- fentanyl  Group F- fentanyl 50 microgram in 10ml saline  
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Physical Status: ASA grade I and II 
 
ExclusionCriteria 
Details  Patients not giving consent
- Patient with neuropathy
- ASA III and more
-History of hypersensitivity to the drugs under study
-History of substance abuse 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain evaluation during first 24 hours as assessed by VAS   At 2,4,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Time of requirement of first rescue analgesia, Supplemental analgesic requirement & side effects like sedation, nausea, & vomiting   from time 0 to the onset of pain in 24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   20/10/2024 
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="1"
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 - NO
Brief Summary  

Patients undergoing anterior cruciate ligament reconstructivesurgery commonly complain of high-intensity pain in the postoperative period due to tear of muscles and ligaments etc. Postoperative pain is the leading cause of prolonged hospital stay and delayed rehabilitation. Conventionally, postoperative pain relief in anterior cruciate ligament reconstructive surgery is achieved by using systemic analgesics, preferably opioids, which have their own set of deleterious effects like nausea, vomiting, pruritus, respiratory depression, and sedation etc. Epidural morphine has also been shown to be effective for pain relief but it needs technical expertise and its use is associated with side effects like sedation and respiratory depression. Local infiltrative analgesia is advantageous in terms of fewer side effects and ease of application, but its analgesic effect is short-lasting. Many local anaesthetic agentslike bupivacaine are being used as local infiltrative analgesiabut has limited duration of action (4-6 hours). The peripheral analgesic effect of fentanyl was reported long back and recent scientific evidence has finally unravelled the presence of activated opioid receptors at the incision site. Initial few studies have shown a promising analgesic effect and therefore, it has rekindled interest in local infiltration of fentanyl for its potent peripheral analgesic effect. Interestingly, the localinfiltration of fentanyl is devoid of the distressing side effects of systemic opioids as mentioned above.

We aim to conduct a double blind randomized controlled trial comprising of three groups with 35 patients in each group. Group â€˜B’ will be infiltrated with 10 ml of 0.25% bupivacainehydrochloride.  Group â€˜F’ will be infiltrated with 50 micrograms of Fentanyl citrate diluted in 10 ml of normal saline and Group â€˜BF’ will be infiltrated with 10 ml of solution containing 9ml of 0.25% bupivacaine hydrochlorideand 50 micrograms (1 ml) of fentanyl citrate at the surgical wound site in patients undergoing anterior cruciate ligamentreconstructive surgery under general anaesthesia. Post-surgery, we plan to assess pain relief with the help of visual analogue scale (VAS) and the total analgesic requirement of supplemental analgesic drugs will be recorded for 24 hours from infiltration of drug. Side effects of opioids namelynausea, vomiting and sedation will be assessed in all the threegroups. We anticipate that analgesic efficacy of fentanyl will be better than bupivacaine for wound infiltration in patients undergoing anterior cruciate ligament reconstructive surgeryunder general anaesthesia.

 
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