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CTRI Number  CTRI/2025/05/087318 [Registered on: 21/05/2025] Trial Registered Prospectively
Last Modified On: 17/05/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to assess the analgesic efficacy of regional block for analgesia with three different doses of local anesthesia 
Scientific Title of Study   A randomized comparative clinical trial of the analgesic efficacy of adductor canal block using 0.2% ropivacaine, 0.5% and 0.75% ropivacaine for postoperative management in total knee replacement  
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Diwan 
Designation  Senior Consultant  
Affiliation  Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005 Pune MAHARASHTRA 
Address  operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  8279806434  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Diwan 
Designation  Senior Consultant  
Affiliation  Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005 Pune MAHARASHTRA 
Address  operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  8279806434  
Fax    
Email  sdiwan1965@gmx.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Diwan 
Designation  Senior Consultant  
Affiliation  Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005 Pune MAHARASHTRA 
Address  operation theatre complex, Second floor, Department of Anesthesiology,Sancheti Institute of Orthopedics and Rehabiliation, 16 Shivajinagar, Pune 411005

Pune
MAHARASHTRA
411005
India 
Phone  8279806434  
Fax    
Email  sdiwan1965@gmx.com  
 
Source of Monetary or Material Support  
Sancheti Institute of Orthopedics and Rehabilitation, 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India  
 
Primary Sponsor  
Name  Sancheti Institute of Orthopedics and Rehabilitation 
Address  11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,India  
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 
Sandip Diwan  Sancheti Instituteof Orthopedicsand Rehabiliation   operation theatre, Department of Anesthesiology,Operation theater, Second floor,Sancheti Hospital 11/12 Thube Park,16, Shivajinagar, Pune – 411005Maharashtra, India PuneMAHARASHTRA Pune MAHARASHTRA Pune MAHARASHTRA Pune MAHARASHTRA
South
DELHI 
9823029328

sdiwan1965@gmx.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Sancheti institute of Orthopedics and Rehabilitationf   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M96-M96||Intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adductor canal block using 0.2% ropivacaine  Ultrasound-guided adductor canal block will be given using 20 ml of 0.2% ropivacaine after surgery Edit || Delete  
Intervention  Adductor canal block using 0.5% ropivacaine   Ultrasound-guided adductor canal block will be given using 20 ml of 0.5% ropivacaine after surgery  
Comparator Agent  Adductor canal block using 0.75% ropivacaine  Ultrasound-guided adductor canal block will be given using 20 ml of 0.75% ropivacaine after surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients above 18 years or older
2. Patients scheduled for elective unilateral total knee arthroplasty
3. Patients who are medically fit for regional anesthesia
4. Patients who have given informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1. Patients with known allergies to local anesthetics used in the study
2. Patients with contraindications to regional anesthesia, such as infection at the site of injection, coagulopathy, or severe peripheral neuropathy
3. Patients with pre-existing neurological deficits in the lower extremities
4. Patients who are pregnant or breastfeeding
5. Patients who are unable to understand the study procedures or cooperate due to cognitive impairment or language barriers
6. Patients who refused to give consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the quadriceps muscle strength between the two groups.  checked at 1,2,4,8,12 and 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
1.Comparing the NRS at various time points
2. Assessing the opioid requirement post-surgery for each block
3.Time to first analgesia (TTFA).
4.Comparing the time to ambulation post-surgery.
 
1. NRS will be checked at 1,2,4,8,12 and 24 hours
2. Total opioid dose in 24 hours
3. time to first opioid requirement in 24 hours postoperative period
4. Time to first ambulation in postoperative period  
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   02/06/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Adequate pain management is crucial for timely discharge of patients after total knee arthroplasty (TKA) surgeries. Regional anaesthesia, particularly peripheral nerve blocks, has become increasingly important in optimizing postoperative pain management and expediting discharge.At present, various techniques can be used to relieve postoperative pain, including epidural anaesthesiafemoral nerve block (FNB), adductor canal block (ACB), and local infiltration analgesia (LIA). A recent network analysis suggests the consideration of a single injection femoral nerve block combined with a sciatic nerve block, or local infiltration analgesia for knee surgeries. [1]

While femoral nerve blocks (FNB) have been associated with less pain and reduced analgesic consumption, there is an increased risk of motor weakness of the quadriceps muscles, and accidental falls as compared to a placebo. [2,3] Besides short-term effects, a decreased quadriceps strength has also been observed six weeks after ACL reconstruction in patients who had received FNB. [4] Recently, ACB has emerged as an alternative to FNB, with the advantage of sparing the motor nerve supply to most of the quadriceps muscle and may lead to a reduction in falls after surgery. [5] Several studies have reported similar pain relief and a reduction in the loss of quadriceps motor strength in favor of ACB compared to FNB. [6,7,8] However, other studies have reported more pain after ACB, or similar quadriceps muscle function between both groups. [9,10,11]

 Readiness for discharge is an important patient outcome, including various factors such as pain management, associated side effects, mobility, vital parameters, and the presence of any surgical complications such as bleeding [18]. Adductor canal block with higher volume or concentrations may affect quadriceps strength, while higher concentrations may have more analgesic efficacy.[19] Data are limited on comparison of different concentrations of local anaesthetic agents (LA) for adductor canal block (ACB). We hypothesized that 0.5% ropivacaine would provide superior analgesic efficacy to 0.2% ropivacaine. Hence, we plan to compare the impact of two different concentrations of ropivacaine for ACB with regards to its analgesic efficacy and quadriceps muscle strength in patients undergoing total knee arthroplasties.

 
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