| CTRI Number |
CTRI/2024/02/062851 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of ultrasound guided suprainguinal fascia iliaca block versus anterior quadratus lumborum block for postoperative analgesia in hip surgeries |
|
Scientific Title of Study
|
Comparative evaluation of ultrasound guided suprainguinal fascia iliaca block versus anterior quadratus lumborum block for postoperative analgesia in hip 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 Neeru Luthra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815500960 |
| Fax |
|
| Email |
drneeru1977@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashna Goel |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8194900424 |
| Fax |
|
| Email |
ashna17goel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashna Goel |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8194900424 |
| Fax |
|
| Email |
ashna17goel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana.
141001
Punjab
India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College And Hospital |
| Address |
Tagore Nagar,Civil lines Ludhiana.141001 Punjab India |
| Type of Sponsor |
Private 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 Neeru Luthra |
Dayanand Medical College and Hospital |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines, Tagore Nagar, Ludhiana
141001
Ludhiana
PUNJAB |
9815500960
drneeru1977@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethical Committee Dayanand Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparative evaluation of ultrasound guided suprainguinal fascia iliaca block versus anterior quadratus lumborum block for postoperative analgesia in hip surgeries |
In group Q 30 ml of 0.2% ropivacaine will be injected in a fascial plane between quadratus lumborum muscle and psoas major muscle using ultrasound guided approach |
| Intervention |
Comparative evaluation of ultrasound guided suprainguinal fascia iliaca block versus anterior quadratus lumborum block for postoperative analgesia in hip surgeries |
In group S 30 ml of 0.2% ropivacaine will be injected in the fascial plane between fascia iliaca and iliacus muscle in suprainguinal area using ultrasound guided approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1Patients scheduled for hip surgeries - hip hemiarthroplasty, total hip arthroplasty, dynamic hip screw fixation under SAB.
2ASA I, II, III& IV patients.
Patient’s cognitive ability to comprehend Numerical Rating Scale (NRS) |
|
| ExclusionCriteria |
| Details |
1Patient refusal
2Infection at injection site
3Patient with known allergy to any of the study drug
4Patients receiving epidural/general anaesthesia
5Patients on chronic opioid abuse or use of opioids in chronic analgesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of anterior QL block versus SIFI block using NRS in postoperative period (0-24 hours). |
0,2,4,6,8,12,16,20,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
⮚Duration of analgesia - Time interval from administration of peripheral nerve block to requirement of first rescue analgesic (tramadol) will be compared in both groups.
⮚Comparative consumption of total opioid (tramadol) in first 24 hours after surgery among both groups.
⮚To compare effect on hemodynamic parameters: Blood pressure (SBP, DBP, MAP), heart rate (HR), respiratory rate,SpO2 |
0,2,4,6,8,12,16,20,24 hours |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
22/02/2024 |
| 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="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
|
Hip surgeries are commonly associated with hyperalgesia affecting recovery and convalescence, therefore effective pain management is of paramount importance. The suprainguinal fascia iliaca (SIFI) block and quadratus lumborum (QL) block are well tolerated and provide site specific analgesia hence gaining popularity.The study will be conducted in a randomized double blinded manner on a total of 54 adult patients belonging to ASA (American Society of Anaesthesiologists) grade I,II,III & IV scheduled for hip surgeries under SAB. Patients will be allocated to two groups of 27 each using computer generated random numbers list.In group S,SIFI block and in group Q,anterior QL block will be administered using 30 ml of 0.2% ropivacaine. Postoperatively, monitoring of vitals and assessment of pain will be conducted using Numerical Rating Scale (NRS) in the Post anaesthesia care unit (PACU) every 2 hourly for first 8 hours and after that 4 hourly till 24 hours. Any patient complaining of NRS>4 will be administered rescue analgesic which is injection tramadol 50mg intravenously to a maximum dose of 400 mg within 24 hours. NRS and total rescue analgesic consumption in 24 hours will be recorded.
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