| CTRI Number |
CTRI/2025/07/090740 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| 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
|
Comparison of single(adductor canal block) versus two blocks(adductor canal blockand IPACK block) for postoperative analgesia after knee surgery in adult patient.
|
|
Scientific Title of Study
|
Randomized study to compare adductor canal block and combination of adductor canal block with ipack block for post operative analgesia in adult patient undergoing knee surgery |
| 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 Rushali Thakkar |
| Designation |
Second year resident doctor anesthesiology |
| Affiliation |
B J Medical college Civil hospital |
| Address |
F3 department of anesthesiology Civil hospital
Ahmadabad Gujrat
380016
Ahmadabad GUJARAT 380016 India |
| Phone |
8320525339 |
| Fax |
|
| Email |
rushalithakkar7299@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor and Head of department Anesthesiology |
| Affiliation |
B J Medical college Civil hospital |
| Address |
F3 department of anesthesiology Civil hospital
Ahmadabad Gujrat
380016
Ahmadabad GUJARAT 380016 India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Smita R Engineer |
| Designation |
Professor and Head of department Anesthesiology |
| Affiliation |
B J Medical college Civil hospital |
| Address |
F3 department of anesthesiology Civil hospital
Ahmadabad Gujrat
380016
Ahmadabad GUJARAT 380016 India |
| Phone |
9825504948 |
| Fax |
|
| Email |
seng_90@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government of gujrat Health and family welfare department 7th floor new sachivalay Gandhinagar 382010 Gujrat India |
|
|
Primary Sponsor
|
| Name |
Government of gujrat |
| Address |
Health and family welfare department 7th floor new sachivalay Gandhinagar 382010 Gujrat India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rushali Thakkar |
Trauma center civil hospital Ahmadabad |
Orthopedic surgery operation theater at 4th floor trauma center civil hospital Ahmadabad Ahmadabad GUJARAT |
8320525339
rushalithakkar7299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B J medical college and civil hospital ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M239||Unspecified internal derangement of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block
|
Effects of adductor canal block(Inj. bupivacaine 0.125% 20ml)for postoperative period 24 hours in adult patients undergoing knee surgery |
| Intervention |
Combination of adductor canal block and IPACK block |
combine effects of adductor canal block(Inj. bupivacaine 0.125% 10ml)and ipack(Inj. bupivacaine 0.125% 10ml)for postoperative period 24hours in adult patients undergoing knee surgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to consent for the study
BMI-18-35 kg/m2
American Society of Anesthesiologist (ASA) Classification I, II, III
Elective Knee Surgery under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with pre-existing respiratory diseases, cardiac diseases
Pregnant patients
Patients with history of bleeding disorders or on anticoagulant therapy
Patient refusal to participate in study
Infection at or near injection site
H/O previous knee surgery
Allergy to local anesthetics
Bilateral knee arthroplasty
Patient with neuropathic pain of lower limb |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
POSTOPERATIVE PAIN SCORE EVALUATED BY VRS(VERBAL RATING SCORE)
1.VRS(R)AT REST
2.VRS(M)AT MOVMENT |
Time from block to be given preoprative to the 24 hours postoperative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intra operative and post operative hemodynamic monitoring.
2.Post-operative requirement of opioid Analgesic.
3.Incidence of complication related to block(numbness,infection,hematoma).
4.Patient satisfaction score-a verbal neumeric rating scale of patient satisfaction will be obtained in post operative period(no satisfaction/partial satisfaction/complete satisfaction).
|
Time from block to be given preoprative to the 24 hours postoperative period. |
|
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Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
25/07/2025 |
| 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="2" 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
|
Effective pain management after knee surgery is crucial for early mobilization and reduced hospital stays. Peripheral nerve blocks have become preferred techniques to control postoperative pain while minimizing opioid use and related side effects. Among these, the adductor canal block (ACB) offers good analgesia while preserving quadriceps strength, aiding faster rehabilitation by targeting key sensory nerves around the knee. However, ACB alone does not adequately cover posterior knee pain. The IPACK block, which anesthetizes terminal sciatic nerve branches, complements ACB by addressing posterior knee discomfort without causing foot drop. So this study is plane to evaluate and compare the effect of combination of these two block. |