| CTRI Number |
CTRI/2024/11/076544 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between hip nerve block and groin nerve block for perioperative pain control in patients undergoing hip replacement surgery |
|
Scientific Title of Study
|
Comparison between pericapsular nerve group block and suprainguinal fascia iliaca block for perioperative pain control in hip arthroplasty: A randomized controlled 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 |
ANNU JOSE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AL AZHAR MEDICAL COLLEGE |
| Address |
ROOM NO 10
DIVISION 6
DEPARTMENT OF ANAESTHESIOLOGY
AL AZHAR MEDICAL COLLEGE
EZHALLOOR PO
THODUPUZHA
IDUKKI
KERALA
INDIA
Idukki KERALA 685605 India |
| Phone |
9074775410 |
| Fax |
|
| Email |
annulizbethjose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
ANNU JOSE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AL AZHAR MEDICAL COLLEGE |
| Address |
ROOM NO 10
DIVISION 6
DEPARTMENT OF ANAESTHESIOLOGY
AL AZHAR MEDICAL COLLEGE
EZHALLOOR PO
THODUPUZHA
IDUKKI
KERALA
INDIA
Idukki KERALA 685605 India |
| Phone |
9074775410 |
| Fax |
|
| Email |
annulizbethjose@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
ANNU JOSE |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AL AZHAR MEDICAL COLLEGE |
| Address |
ROOM NO 10
DIVISION 6
DEPARTMENT OF ANAESTHESIOLOGY
AL AZHAR MEDICAL COLLEGE
EZHALLOOR PO
THODUPUZHA
IDUKKI
KERALA
INDIA
Idukki KERALA 685605 India |
| Phone |
9074775410 |
| Fax |
|
| Email |
annulizbethjose@gmail.com |
|
|
Source of Monetary or Material Support
|
| AL AZHAR MEDICAL COLLEGE
EZHALLOOR PO
PIN 685605
THODUPUZHA
IDUKKI
KERALA
INDIA |
|
|
Primary Sponsor
|
| Name |
AL AZHAR MEDICAL COLLEGE |
| Address |
AL AZHAR MEDICAL COLLEGE EZHALLOOR PO
PIN 685605
THODUPUZHA
IDUKKI
KERALA
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 ANNU JOSE |
AL AZHAR MEDICAL COLLEGE MAIN OPERATION THEATRE |
ROOM NO 10
DIVISION 6
DEPARTMENT OF ANAESTHESIOLOGY
EZHALLOOR PO 685605
THODUPUZHA
IDUKKI
KERALA
INDIA Idukki KERALA |
9074775410
annulizbethjose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee,Al Azhar Medical College,Ezhalloor |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M16||Osteoarthritis of hip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular nerve group block |
USguided nerve block technique using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.
DURATION OF PROCEDURE-20 MINUTES
DURATION OF BLOCK ACTION-24 HOURS |
| Comparator Agent |
Suprainguinal fascia iliaca block |
USguided nerve block technique using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.
DURATION OF PROCEDURE-20 MINUTES
DURATION OF BLOCK ACTION-24 HOURS |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status 1-3 patients
2.Age 25-80yrs
3.Scheduled for primary hip arthroplasty under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
1.Surgeries under GA
2.Patients who refused to give consent
3.Those with focal neurological deficit
4.History of allergy to local anaesthetic
5.Infection at the puncture site
6.Unable to understand NRS
• Coagulopathy/sepsis/hepatic or renal failure
• prior surgery of the inguinal or suprainguinal area
|
|
|
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 |
.post block NRS at rest and on passive 15° limb lifting
.Ease of spinal positioning
.postoperative morphine requirement |
30 minutes after the block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
. NRS over 24 hours
.amount of morphine used (number of rescue doses)
. degree of quadriceps weakness. |
24 hours postoperative period |
|
|
Target Sample Size
|
Total Sample Size="66" Sample Size from India="66"
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)
|
01/12/2024 |
| 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
|
Pain associated with hip surgery -a significant problem-Complications, morbidities, and low
levels of patient satisfaction.Two
blocks that have recently become popular for hip analgesia include pericapsular
nerve group (PENG) block and SIFI block.There is paucity in literature regarding these blocks and to which one
is more efficacious. We hypothesised that SIFI block would provide better analgesia without
significant quadriceps muscle weakness when compared with the PENG block
following THA. The study will be carried out in accordance
with the ethical principles of the Declaration of Helsinki, 2013. Its procedure
will be explained to each patient, and a written and informed consent will be
taken for participation in this study and for the use of the patient data for
educational and research purposes.
The consultant doing the pre-anaesthetic check-up will carry out a
consecutive sampling of all eligible participants and enroll them into the
study. Randomisation will be done by an independent statistician using software
for block randomisation techniques of varying block sizes (3–5). Allocation
concealment will be done using serially numbered, opaque, sealed envelopes
(SNOSE technique). The sealed envelope will be opened by a consultant who is
not part of the study once the patient
reaches the pre-medication room, thus assigning the participant to the
intervention. This assigned consultant then performs the block in the block
room. All
observations will be done in the operating room and PACU by the investigator who is unaware of the regional block
performed. All the
participants will remain blinded to the block administered. NRS score will be explained to the patients at the time of pre-operative
assessment.Pre-procedure pain will be
assessed during rest as well as on movement (15° passive elevation) of
the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain;
10 = worst imaginable pain]. The blocks will be performed in supine position following sterile
techniques. Both the blocks will be performed as per the standard USguided
techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone.
After the block, patient will be shifted to the operating room and will
be continuously monitored with non-invasive blood pressure every 5 minutes,
continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity
for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by
NRS at rest and on passive limb elevation. If any patient had NRS >5,
intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score
becomes 3, and then, they will be allowed for sitting position for SA.NRS score will be explained to the patients at the time of pre-operative
assessment.Pre-procedure pain will be
assessed during rest as well as on movement (15° passive elevation) of
the affected limb and recorded on numeric pain rating scale (NRS) [0 = no pain;
10 = worst imaginable pain].
The blocks will be performed in supine position following sterile
techniques. Both the blocks will be performed as per the standard USguided
techniques using 30 ml 0.2 % ropivacaine with 4mg dexamethasone. After the block, patient will be shifted to the operating room and will
be continuously monitored with non-invasive blood pressure every 5 minutes,
continuous ECG and pulse oximetry and for signs of local anaesthetic toxicity
for 30 minutes. Thirty minutes after the blocks, analgesia will be measured by
NRS at rest and on passive limb elevation. If any patient had NRS >5,
intravenous (IV) fentanyl 20 µg will be given every 5 minutes till NRS score
becomes 3, and then, they will be allowed for sitting position for SA. The amount of fentanyl used, NRS scores and scores for EOSP will be
recorded.
All observations will be done by another anaesthesiologist who is
unaware of the regional block performed. All patients will receive spinal
anesthesia with 10mg of hyperbaric bupivacaine (ie, 2mL of bupivacaine 0.5%)
and 20µg of fentanyl.All interventions will be performed by the same team of
surgeons using a posterior approach and a lateral decubitus position.
Postoperative analgesia will be
provided with IV paracetamol 1 gm every 8 h. The rescue analgesia will
be provided with 1 mg morphine on demand or when NRS is >4.All patients will
be followed up postoperatively at 2,4, 6, 8, 12 and 24 hours. |