| CTRI Number |
CTRI/2024/09/073796 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of of dual sub sartorial block effect on pain relief using two different volumes of drug in patients undergoing single knee surgery |
|
Scientific Title of Study
|
Comparing analgesic efficacy of a novel dual sub sartorial block using two different volumes in patients undergoing unilateral knee arthroscopy and ligament repair: A prospective, double blind, Monocentric, Randomized trial |
| 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 D Vijay Kumar |
| Designation |
Resident, Anaesthesiology |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesiology, Armed Forces Medical College, Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9550736196 |
| Fax |
|
| Email |
drvkdvizag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Sood |
| Designation |
Head of Department, Anaesthesiology |
| Affiliation |
Military hospital Kirkee |
| Address |
Department of Anaesthesiology,
Military Hospital Kirkee,
Pune
Pune
MAHARASHTRA
411020
India |
| Phone |
9550736196 |
| Fax |
|
| Email |
saurabhsood1975@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Sood |
| Designation |
Head of Department, Anaesthesiology |
| Affiliation |
Military hospital Kirkee |
| Address |
Department of Anaesthesiology,
Military Hospital Kirkee,
Pune
Pune
MAHARASHTRA
411020
India |
| Phone |
9550736196 |
| Fax |
|
| Email |
saurabhsood1975@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Military Hospital Kirkee
Pune India 411020 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Military Hospital Kirkee |
| Address |
Department of Anaesthesiology, Military Hospital Kirkee, Pune
India 411020 |
| Type of Sponsor |
Other [Military 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 D Vijay Kumar |
Military hospital Kirkee |
Dept of Anaesthesiology ,Operation Theatre Complex , 3rd Floor
Pune
MAHARASHTRA |
9550736196
drvkdvizag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Military Hospital Kirkee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dual subsartorial block is administered using 30 ml local Anaesthetic |
In one group, Dual sub sartorial block administered using 30ml (Inj Levobupivacaine 0.25% + Inj Dexmeditomedine 0.5mcg/kg) |
| Comparator Agent |
Dual subsartorial block is administered using 40 ml local Anaesthetic |
In one group, Dual sub sartorial block administered using 40ml (Inj Levobupivacaine 0.25% + Inj Dexmeditomedine 0.5mcg/kg) Edit || Delete
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with ASA I, ASA II and ASA III grades
2. Patients undergoing unilateral knee arthroscopy and ligament repair for the first time
3. Patients with known comorbidities such as Hypertension, diabetes are also included |
|
| ExclusionCriteria |
| Details |
1. Patients with ASA IV grades
2. Patients undergoing bilateral knee arthroscopy and ligament repair or for the first time
3. Patients allergic to local anaesthetic agents
4. Patients with same side hip joint pathology |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To measure analgesic efficacy of Local anaesthetic when used in two different volumes at different time points post block |
Pain score (VAS score), Sensory block regression, Motor strength (Quadriceps weakness) is measured immediately post block and every 2hrs up to 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess motor strength in both the groups when Local anaesthetic is administered in two different volumes in DSSB |
Motor strength (Quadriceps weakness) is measured immediately post block and every 2hrs up to 24hrs |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/09/2024 |
| 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="6"
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
|
Unilateral meniscal injuries are commonly admitted cases in our hospital. Arthroscopic meniscal repair is surgical treatment modality for the meniscal injury patients . However, knee arthroscopic surgeries are associated with significant pain post surgery. Dual Sub sartorial block (DSSB) is a novel regional anaesthesia technique useful in providing analgesia to post operative patients of knee arthroscopy and meniscal repairs. In dual sub sartorial block, we give local anaesthetic drug in both distal femoral canal and proximal adductor canal . In our study we would like to compare analgesic efficacy of two drug volumes of local anaesthetic administered in DSSB. In one group, Dual sub sartorial block administered using 30ml (Inj Levobupivacaine 0.25% + Inj Dexmeditomedine 0.5mcg/kg). In one group, Dual sub sartorial block administered using 40ml (Inj Levobupivacaine 0.25% + Inj Dexmeditomedine 0.5mcg/kg). Vitals are measured before and after the block administration. Pain score measured through VAS scoring system , sensory block regression, motor weakness are also measured immediately and at different timepoints post block. |