| CTRI Number |
CTRI/2021/07/034754 [Registered on: 12/07/2021] Trial Registered Prospectively |
| Last Modified On: |
11/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Ropivacaine and Levobupivacaine in ultrasound guided Adductor canal nerve block for early mobility in patients undergoing Anterior Cruciate Ligament reconstruction surgery. |
|
Scientific Title of Study
|
Comparison of Ropivacaine and Levobupivacaine in ultrasound guided Adductor canal block for early ambulation in patients undergoing Anterior Cruciate Ligament reconstruction surgery.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nikhil Vinay Sharma |
| Designation |
Post Graduate Student in department of anaesthesia |
| Affiliation |
ABVIMS and RML HOSPITAL |
| Address |
Department of Anaesthesia
ABVIMS And Dr RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110010
India |
| Phone |
08700367990 |
| Fax |
|
| Email |
drnikvin23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MOHANDEEP KAUR |
| Designation |
Prof And Head of department of Anaesthesia |
| Affiliation |
ABVIMS and RML HOSPITAL |
| Address |
Department of Anaesthesia
ABVIMS And Dr RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110001
India |
| Phone |
9868952253 |
| Fax |
|
| Email |
mdkaur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Vinay Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and RML HOSPITAL |
| Address |
Department of Anaesthesia
ABVIMS And Dr RML HOSPITAL
NEW DELHI
New Delhi
DELHI
110010
India |
| Phone |
08700367990 |
| Fax |
|
| Email |
drnikvin23@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS Dr Ram Manohar Lohia Hospital |
|
|
Primary Sponsor
|
| Name |
Dr RML HOSPITAL AND ABVIMS |
| Address |
Baba Kharak Singh Rd near Gurudwara Bangla Sahib Ram Manohar Lohia Hospital Type III Connaught Place New Delhi Delhi 110001 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Dr Nikhil Vinay Sharma |
ABVIMS Dr Ram Manohar Lohia Hospital |
Department of anaesthesia
Dr. RML HOSPITAL AND ABVIMS
NEW DELHI
110001
New Delhi
DELHI |
8700367990
drnikvin23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituttional Ethics Committee ABVIMS Dr RML hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:S83||Dislocation and sprain of joints and ligaments of knee. Ayurveda Condition: not, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Use of Levobupivacaine for ultrasound guided Adductor canal block for early ambulation in patients undergoing Anterior Cruciate Ligament reconstruction surgery |
A linear ultrasound probe (sonosite) will be used for performing the block. For ACB, the ultrasound probe will be placed at the mid-thigh level halfway between the anterior superior iliac spine and patella. The femoral artery underneath the sartorius muscle will be identified. The saphenous nerve lies just lateral to the artery. A 21-G,5-cm needle will be introduced in plane and advanced into the adductor canal. On reaching the adductor canal, 2–3 ml of saline will be injected to ensure correct placement of needle, i.e., spread of saline in the vicinity of saphenous nerve. After confirmation, 20ml of group specific study drug will be injected in the adductor canal.The primary outcome of the study, i.e., early ambulation will be assessed by asking the patient to perform a Straight Leg Raise test (SLR) in supine position. The assessment will begin in the postoperative care unit (0h), every 2 hourly in initial 4 hours, then every 4 hourly for 20 hours. |
| Intervention |
Use of Ropivacaine for ultrasound guided Adductor canal block for early ambulation in patients undergoing Anterior Cruciate Ligament reconstruction surgery. |
A linear ultrasound probe (sonosite) will be used for performing the block. For ACB, the ultrasound probe will be placed at the mid-thigh level halfway between the anterior superior iliac spine and patella. The femoral artery underneath the sartorius muscle will be identified. The saphenous nerve lies just lateral to the artery. A 21-G,5-cm needle will be introduced in plane and advanced into the adductor canal. On reaching the adductor canal, 2–3 ml of saline will be injected to ensure correct placement of needle, i.e., spread of saline in the vicinity of saphenous nerve. After confirmation, 20ml of group specific study drug will be injected in the adductor canal. The primary outcome of the study, i.e., early ambulation will be assessed by asking the patient to perform a Straight Leg Raise test (SLR) in supine position. The assessment will begin in the postoperative care unit (0h), every 2 hourly in initial 4 hours, then every 4 hourly for 20 hours. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled to undergo elective ACL reconstruction surgery under general anesthesia. |
|
| ExclusionCriteria |
| Details |
Pre-existing coagulation disorders.
Local infection at the site of injection.
Allergy to study drug(prior test dose will be given)
Chronic Pain syndrome
Patients who received any analgesia 24 hours prior to surgery.
|
|
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Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative quadriceps muscle strength using SLR (straight leg raise) test. |
Post operatively every 2 hourly till 4 hours and 4 hourly for the next 20 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time from end of surgery to first rescue analgesia requirement. |
This will be measured from the time of administration of block to the first instance when VAS score will be equal or more than 4 during the 24 hour period while the the patients will be assessed at 2nd,4th,8th,12th,16th,20th,24th and in between if patient complains of pain. |
| Total rescue Analgesia in 24 hours. |
Injection tramadol will be administered intravenously when VAS score is equal or more than four. The total amount of tramadol consumed in 24 hours will be noted. |
|
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Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
21/07/2021 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
This study is a randomized, parallel group, active controlled trial to compare Ropivacaine and Levobupivacaine in ultrasound-guided adductor canal block for early ambulation in patients undergoing ACL reconstruction surgery that will be conducted in the, Department of Anaesthesiology ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi, India. The primary outcome will be postoperative quadriceps muscle strength using SLR (straight leg raising) test. The secondary outcome measures will be time from end of surgery to first rescue analgesia requirement; and total rescue Analgesia requirement in 24 hours. |