| CTRI Number |
CTRI/2024/04/065824 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| 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
|
Comparing 4-1 block against epidural for pain relief in knee and below knee surgeries |
|
Scientific Title of Study
|
Novel vs Traditional : Comparison of 4-l block vs epidural for post operative analgesic needs in knee and below knee surgeries |
| 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 Suprava Kundu |
| Designation |
DNB (3 year course} post graduate Resident |
| Affiliation |
NH MMI Superspecialty Hospital |
| Address |
2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh
Raipur CHHATTISGARH 492001 India |
| Phone |
7978661948 |
| Fax |
|
| Email |
kundu.suprava@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI Superspecialty Hospital |
| Address |
2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh
Raipur CHHATTISGARH 492001 India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arun Andappan |
| Designation |
Senior Consultant |
| Affiliation |
NH MMI Superspecialty Hospital |
| Address |
2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh
CHHATTISGARH 492001 India |
| Phone |
9584411011 |
| Fax |
|
| Email |
arunandappan@gmail.com |
|
|
Source of Monetary or Material Support
|
| MMI Narayana Superspecialty Hospital, Raipur ,Chhattisgarh, pincode- 492001, India |
|
|
Primary Sponsor
|
| Name |
MMI Narayana superspecialty Hospital |
| Address |
new Dhamtari road, Pachpedi naka ,Lalpur, Raipur, Chhattisgarh |
| 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 Suprava Kundu |
MMI Narayana Superspecialty Hospital |
2nd floor, OT complex , Department of Anaesthesiology , MMI Narayana superspecialty Hospital ,Dhamtari Road, Lalpur, Raipur, Chhattisgarh Raipur CHHATTISGARH |
7978661948
kundu.suprava@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,All India Institute of Medical Sciences, Raipur(Chhattisgarh) |
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 |
| Comparator Agent |
Continuous epidural block |
bolus of 0.25% Bupivacaine 5 ml with 0.5 mcg/kg Dexmedetomidine followed followed by infusion of 0.25% Bupivacaine 50 ml with 0.5 mcg/kg Dexmedetomidine at 5ml/hr |
| Intervention |
Four in one block (4-1 block) |
USG Guided 4-1 block given with 0.2% ropivacaine 35 ml along with 0.5 mcg/kg Dexmedetomidine in knee and below knee surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 |
|
| ExclusionCriteria |
| Details |
ASA 3 & 4
Refusal of consent
psychological and neurological disorder
coagulation disorder
infection at local site of injection
history of allergy to LA
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Duration of post-operative analgesia.
2)Total dose of rescue analgesic required in first 24 hours.
3)VAS (Visual Analog Score) in 2, 4, 6, 12, 24 hours post-operatively.
|
2, 4, 6, 12, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To analyze the incidences of complications, if any, associated with 4 in 1 block and Epidural Blocks
2)To assess the side effects of drugs used in the study
3)Length of hospital stay
|
2, 4, 6, 12, 24 hours |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| 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="1" Months="0" 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
|
THESIS
TITLE-
Novel
vs Traditional : comparison of 4-1 block
vs epidural for post operative analgesic needs in knee and below knee
surgeries.
Knee and below
knee surgeries are associated with moderate to severe pain postoperatively
leading to delayed recovery and prolonged hospital stay. Therefore, this study
is to compare two types of analgesia. Aim of our study is to compare post-operative analgesia and motor
performance between 4-1 Block versus Continuous Epidural Block (CEB) in
patients undergoing Knee and below Knee surgeries. Patient will be evaluated on
primary outcomes such as duration of post-operative
analgesia, total dose of rescue analgesic required in first 24 hours, VAS
(Visual Analog Scale) score at 2, 4, 6,
12, 24 hours post-operatively .The secondary outcomes will be to analyze the
incidence of complications if any, to assess the side effects of drug used and
length of hospital stay. Total 80 patients will be taken and they will be
divided randomly into 2 group of 40 each.
Group A-
4-1 BLOCK GROUP : After
surgery, supine position is maintained and the vastus medialis muscle is
identified by ultrasound. Then scanned proximally till the intersection of
vastus and sartorius. Then the probe is slid proximally till the superficial
femoral artery appears in the adductor hiatus.. The probe is then again slid
slowly proximally till the descending genicular artery , a branch from
superficial femoral artery is visualised in the adductor hiatus. Further
proximally where descending genicular artery disappears is the point of
injection. The point is 8-10 cm above the femoral condyle. Under all aseptic
precautions, a 22 gauge, 360 ultrasound compatible 100 mm needle is guided in
plane from lateral to medial side under ultrasound guidance to reach
perivascular regions and after negative aspiration , 0.2% ropivacaine 35 ml along
with 0.5 mcg/kg Dexmedetomidine is injected that is visualised to push the
femoral artery posteriorly.
Group
B- EPIDURAL BLOCK GROUP : Non ultrasonographic guided Epidural block
with bolus dose of 5ml 0.2% Ropivacaine with
0.5mcg/kg Dexmedetomidine will be given followed by the same dose and concentration
of the drug as Continuous Epidural Block infusion at rate of 5ml/hour.
After the blocks, vital parameters will be
monitored and recorded. Side effects will be observed, if any. Visual Analogue
Scale score will be noted at 2, 4, 6, 12 & 24 hours. Length of hospital
stay after the surgery will be noted. All the data will be recorded. |