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
|
|
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
|
|
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 anaesthesia, femoral 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. |