| CTRI Number |
CTRI/2022/09/045997 [Registered on: 28/09/2022] Trial Registered Prospectively |
| Last Modified On: |
23/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparision of 2 nerve blocks to assess which one is better in providing analgesia after total knee replacement surgeries |
|
Scientific Title of Study
|
Comparison of combined adductor canal block and IPACK block versus intra-articular ropivacaine and morphine and Genicular Nerve Block for post operative analgesia in knee arthroscopic procedures |
| Trial Acronym |
ipack |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Samarjit Dey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anaesthesia,Pain and Critical Care, AIIMS Raipur, Raipur , Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
drsamar0002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Samarjit Dey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anaesthesia,Pain and Critical Care, AIIMS Raipur, Raipur , Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
drsamar0002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samarjit Dey |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, Raipur |
| Address |
Department of Anaesthesia,Pain and Critical Care, AIIMS Raipur, Raipur , Chhattisgarh
Raipur
CHHATTISGARH
492099
India |
| Phone |
|
| Fax |
|
| Email |
drsamar0002@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Raipur |
| Address |
All India Institute of Medical Sciences, Raipur, Chhattisgarh,492099 |
| 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 |
| Dr Samarjit Dey |
AIIMS Raipur |
All India Institute of Medical Sciences, Raipur, Chhattisgarh
Raipur
CHHATTISGARH |
8014910806
drsamar0002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
combined adductor canal block and IPACK(injection between the popliteal artery and the capsule of the knee) block |
Patients in “IP†group will receive IPACK block and adductor canal block post operatively under ultrasound guidance.The transducer will then be moved caudally observing the femoral artery as it dives into the popliteal fossa through the adductor hiatus to become the popliteal artery. At this point, the transducer will be moved posteriorly and inferiorly to visualize the space between the popliteal artery and the shaft of the femur just superior to the femoral condyles. The needle will be inserted, in plane, from the anterior end of the transducer in a medial to lateral trajectory, keeping the needle parallel to the acoustic shadow of the femur.
15 mL of 0.2% Ropivacaine will be injected after negative aspiration for blood. The patients in this group will also receive Adductor Canal Block, in which the adductor canal will be identified beneath the sartorius muscle at the mid-thigh level. 20 mL of 0.2% Ropivacaine will be injected into this space.
Parameters recorded will included age, gender, American Society of Anaesthesiologists (ASA) score, body mass index, Numerical rating score (NRS) pain scores at rest and on movement , range of movement and rescue analgesia will be recorded at 8,12, 24 hours post operatively.
|
| Comparator Agent |
intra-articular ropivacaine and morphine and Genicular Nerve Block |
In the “IA†Group intra-articular Morphine (3 mg) along with 0.2% Ropivacaine 12 mL will be infiltrated into the intra articular space using all aseptic and antiseptic precautions. Patients will also receive ultrasound guided Genicular Nerve Blocks post operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Age >18 years and < 60 years
ASA I and II
Patients undergoing unilateral arthroscopic knee surgeries
No pre-existing sensory/motor deficit in lower limb
Patients not on chronic pain therapy for (> 3 months)
Able to comprehend and co-operate with Pain assessment tools
|
|
| ExclusionCriteria |
| Details |
ASA III and IV
Bilateral arthroscopic knee surgeries
Prior vascular surgery on femoral vessels on operated site
Bleeding diathesis
Pre-existing lower extremity neurological abnormality
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the Numerical Rating Scale(NRS) for pain , post-operatively at 8 hours,12 hours and at 24 hours in patients receiving intra-articular ropivacaine and morphine and Genicular Nerve Block versus combined adductor canal block and IPACK block after undergoing knee arthroscopic procedures. |
To compare the Numerical Rating Scale(NRS) for pain , post-operatively at 8 hours,12 hours and at 24 hours in patients receiving intra-articular ropivacaine and morphine and Genicular Nerve Block versus combined adductor canal block and IPACK block after undergoing knee arthroscopic procedures. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the range of movement and Numerical Rating Scale (NRS) post-operatively at 8 hours,12 hours and 24 hours and requirement of rescue analgesia in patients receiving intra-articular ropivacaine and morphine and Genicular Nerve Block versus combined adductor canal block and IPACK block after undergoing knee arthroscopic procedures |
To assess the range of movement and Numerical Rating Scale (NRS) post-operatively at 8 hours,12 hours and 24 hours and requirement of rescue analgesia in patients receiving intra-articular ropivacaine and morphine and Genicular Nerve Block versus combined adductor canal block and IPACK block after undergoing knee arthroscopic procedures |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
01/10/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The present study will assess whether intra-articular ropivacaine and morphine and Genicular Nerve Block is a better alternative for postoperative analgesia as compared to combined adductor canal block and IPACK block in patients undergoing knee arthroscopic procedures. |