| CTRI Number |
CTRI/2025/06/089268 [Registered on: 20/06/2025] Trial Registered Prospectively |
| Last Modified On: |
19/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
COMPARE ULTRASOUND GUIDED COMBINED FEMORAL AND SCIATIC NERVE BLOCK VERSUS COMBINED LUMBAR AND SACRAL PLEXUS BLOCK FOR POST OPERATIVE PAIN RELIEF IN LOWER LIMB SURGERY |
|
Scientific Title of Study
|
Comparision Of USG Guided Combined Femoral And Sciatic Nerve Block versus Combined Lumbar And Sacral Plexus Block For Post Operative Analgesia In Lower Limb Surgery-A Prospective Randomized Comparative Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hansaliya bansiben dharmendrabhai |
| Designation |
Resident doctor in department of anaesthesia |
| Affiliation |
Government Medical College Baroda |
| Address |
Resident doctor, Department of Anaesthesia, Second floor, New Surgical Building, Government Medical College, Baroda.
Vadodara
GUJARAT
390001
India |
| Phone |
07359642378 |
| Fax |
|
| Email |
bansi.hansaliya1212@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KAVITA S LALCHANDANI |
| Designation |
Associate professor,Head of department |
| Affiliation |
Government Medical College Baroda |
| Address |
Department Of Anaesthesia, Second floor, New Surgical Building, Government Medical College, Baroda.
Vadodara
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KAVITA S LALCHANDANI |
| Designation |
Associate professor,Head of department |
| Affiliation |
Government Medical College Baroda |
| Address |
Department Of Anaesthesia, Second floor, New Surgical Building, Government Medical College, Baroda.
Vadodara
GUJARAT
390001
India |
| Phone |
9274586809 |
| Fax |
|
| Email |
lalchandanikavita@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College Baroda,Anandpura,Vadodara,gujarat,India,pin code-390001 |
|
|
Primary Sponsor
|
| Name |
Medical College Baroda |
| Address |
Medical College Baroda,Anandpura,Vadodara pin code-390001 |
| Type of Sponsor |
Government medical college |
|
|
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 Hansaliya bansiben dharmendrabhai |
SSG Hospital |
First floor OT block Government Medical College Baroda Vadodara GUJARAT 390001 India
Vadodara
GUJARAT |
07359642378
bansi.hansaliya1212@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for Biomedical and Health Research |
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 |
Femoral sciatic group |
In femoral sciatic group Usg guided combined femoral and sciatic block will be given in supine position with inj ropivacaine 0.375% 40 ml given and then post operative duration of analgesia and requirment of rescue analgesics will be evaluated for 24 hrs |
| Comparator Agent |
lumbar and sacral plexus group |
In lumbo sacral group Usg guided combined lumbar and sacral plexus block will be given with inj ropivacaine 0.375% total 40 ml drug in lateral position and then post operative duration of analgesia and requirment of rescue analgesics will be evaluated for 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 to 70 year
Either sex
ASA grade 1 to 3
Patient posted for elective lower limb surgery( Hip and femur surgeries)
Patient able to give verbal and informed consent
Patient able to understand VAS regarding assessment of pain.
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anesthetics
Patient with local site infection
Patient with coagulopathy disorder
Patient with cognitive and psychiatric illness
Patient with peripheral neuropathy and neurological deficit
Patient with severe cardiovascular respiratory renal and hepatic disease (ASA grade 4)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia using VAS score(Time interval from end of injecton of drug to first rescue analgesic drug required) |
Till 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of rescue analgesia required in 24 hrs,Post procedural hemodynemics,Complication like nerve injury,hematoma,local anaesthetic systemic toxicity. |
Till 4 hrs |
|
|
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" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
| Our goal of study is to compare efficacy of combined femoral and sciatic nerve block vs combined lumbar and sacral plexus block for post-operative analgesia in patients undergoing lower limb surgery.Primary objective is duration of analgesia using VAS score (Time interval from end of injection of drug to first rescue analgesic drug required).Secondary objectives are number of rescue analgesia required in 24 hrs,post procedural hemodynamics,complications like nerve inury,hematoma,local anaesthetic systemic toxicity.The proposed advantages of our study is
| Less requirements of rescue analgesia in post-operative period of lower limb surgery with early patient ambulation and physiotherapy in both the groups. Lumbosacral block is given at higher level while combined femoral and sciatic block is given individually.FS block is easier to perform compared to lumbosacral block. |
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