| CTRI Number |
CTRI/2024/04/065755 [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
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Post-Operative Analgesic Efficacy of two different drug volumes of same concentration of local anesthetic in patients undergoing hip fracture surgery under ultrasound guided Pericapsular Nerve Group Block around the hip joint |
|
Scientific Title of Study
|
Comparative Evaluation of Post-Operative Analgesic Efficacy of 15 ml of 0.375 % Ropivacaine versus 25 ml of 0.375 % Ropivacaine in patients undergoing hip fracture surgery under ultrasound guided Pericapsular Nerve Group Block: A Prospective Randomised Double Blinded 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 |
Aruna Bharti |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Postgraduate
Institute of Medical Sciences Lucknow
UTTAR PRADESH
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9140225377 |
| Fax |
|
| Email |
cardarone@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sonam Pandey |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Postgraduate
Institute of Medical Sciences Lucknow
UTTAR PRADESH
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
7080635906 |
| Fax |
|
| Email |
drsonam.2013@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sonam Pandey |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences,Lucknow |
| Address |
Department of Anaesthesiology, Sanjay Gandhi Postgraduate
Institute of Medical Sciences Lucknow
UTTAR PRADESH
India
Lucknow UTTAR PRADESH 226014 India |
| Phone |
7080635906 |
| Fax |
|
| Email |
drsonam.2013@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Aruna Bharti |
| Address |
Department Of Anaesthesiology , SGPGIMS, Lucknow |
| Type of Sponsor |
Other [self] |
|
|
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 Sonam Pandey |
Apex trauma centre, SGPGI |
Operation Theatre, Department of Anesthesiology,Apex Trauma Centre, SGPGI Lucknow UTTAR PRADESH |
7080635906
drsonam.2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular Nerve Group Block |
Single shot PENG BLOCK administered using 15 ml of 0.375% Ropivacaine using USG and echogenic needle over 45 seconds |
| Comparator Agent |
Pericapsular Nerve Group Block |
Single shot PENG BLOCK administered using 25 ml of 0.375% Ropivacaine using USG and echogenic needle over 45 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who had given written informed consent
2. Patients belonging to ASA grade I and II.
3. All genders
4. Patients in the age group of 18 yrs and above
5. Patient with hip fracture ( fracture neck of femur, intertrochanteric and subtrochanteric fractures).
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. ASA grade III and IV
3. Emergency surgeries
4. Patients with polytrauma
5. Patient who had allergy and intolerance to local anesthetics & have active skin infection.
6. Patient with cognitive impairment, delirium, dementia and severe hearing impairment
7. Coexisting coagulopathy or anticoagulant or antiplatelet treatment that would be a contraindication to regional anesthesia.
8. Patient having diabetes, ischemic and valvular heart disease, pre-existing neurologic deficits in the limb .
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the Mean NRS (Numeric Rating Scale) to assess static and dynamic pain between two treatment groups |
Post operative at 2,4,6,12,18,24,30,36,42 and 48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Quality of recovery at 24 & 48 hrs as measured by the QoR 15 questionnaire
2. Mean opioid consumption at 24 & 48 hrs
3. Pain score during positioning for spinal anesthesia |
upto 48 hrs
Pain during positioning at 15 mins after giving block |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| Date of Study Completion (India) |
24/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 fracture is an increasingly common
emergency surgical presentation particularly amongst elderly and a rising
social and economic burden. This reflects the high morbidity and mortality of
the condition , particularly among the frail elderly .PENG(Pericapsular Nerve
Group) Block was first described by Phillip W.H. Peng in July, 2018 . PENG
block is a novel regional anesthesia technique that has been proposed as an
effective motor sparing block for total hip arthroplasty. PENG Block targets the
articular branches of femoral ,obturator and accessory obturator nerves
providing innervation to the anterior capsule of the hip joint. Its potential
motor sparing effect is desirable for early ambulation , better physical
therapy and earlier discharge . The potential analgesic benefit provided by
this block, without impairing motor function , positively impact patient mood,
sleep, appetite and over all well being. Ropivacaine is an amide local
anesthetic with predilection for sensory blockade. We hypothesize that 15 ml of
0.375% ropivacaine would be able to achieve similar analgesic effects as 25ml
of 0.375% ropivacaine. Studies conducted so far to assess the analgesic
efficacy of PENG block have used local anaesthetic in a volume ranging from 8
to 30 ml and concentration 0.2% to 0.5% . Inclusion criteria: 1.Patient
wo had given written informed consent 2.Patients belonging to ASA grade I and II. 3.All genders 4.Patients
in the age group of 18 yrs and above 5.Patient with hip fracture ( fracture
neck of femur, intertrochanteric and subtrochanteric fractures). Exclusion
criteria : 1.Patient refusal. 2.ASA grade III and IV 3.Emergency
surgeries 4.Patient with polytrauma 5.Patient who had allergy and
intolerance to local anesthetics & have active skin infection. 6.Patient
with cognitive impairment, delirium, dementia and severe hearing impairment.
7.Coexisting coagulopathy or anticoagulant or antiplatelet treatment that
would be a contraindication to regional anesthesia. 8.Patient having diabetes ,
ischemic and valvular heart disease, pre-existing neurologic deficits in the limb . After
obtaining approval from the institutional ethics committee of SGPGIMS and
written informed consent from the patients, the study will be conducted with
the study population being the patients undergoing surgery for hip fracture.
Patients will be randomly allocated by use of block randomization method using
software ‘Sealed Envelopeâ€.The duration of study is going to be for about 18
months. Subjects will be placed in
supine position,standard ASA monitors will be applied, oxygen will be
administered via nasal cannula. Intravenous midazolam and fentanyl will be
titrated for patient comfort. After skin disinfection and draping, a
curvilinear low frequency probe (2-5 Hz) will be initially placed in a
transverse plane over the anterior inferior iliac spine ,before being aligned
with the pubic ramus by rotating the probe 45 degree counterclockwise .The skin
puncture site will be anesthetized using 2% lignocaine (2-3 ml ) A 22G 100 mm
echogenic needle(Pajunk or Stimuplex needle) will be inserted from lateral to
medial in an in- plane approach and will be advanced to the target site i.e.
between the psoas tendon anteriorly and pubis ramus posteriorly .In group A, 15
ml of 0.375 % Ropivacaine will be injected and in group B, 25 ml of 0.375% ropivacaine will be injected
to the target site. In both the groups , 4 mg of injection dexamethasone will
be administered intravenous at the time of block placement .[8 Negative
aspiration should be observed before injection of local anesthetic into the
plane and observation of fluid spread in the desired plane. Pain during
positioning(i.e. sitting position or Hamstring stretch position) for spinal
anesthesia will be assessed using the pain score (score 0 = calm, 1 = facial
grimacing, 2 = moaning, 3 = screaming, and 4 = unable to proceed because of
restlessness or agitation). 30 minutes after placement of Pericapsular Nerve
Group Block, spinal anesthesia will be administered using 0.5 % hyperbaric bupivacaine
with a dose range of 12-15 mg based on patient height along with 15 mcg of
fentanyl. Patients in both the groups will receive same care pre and
postoperatively. Post operatively subjects in both the groups will receive
scheduled paracetamol (15 mg/kg) six hourly as part of a multimodal pain
regimen. Static and dynamic pain assessment will be done at 2h, 4h, 12h, 18h,
24h,30h, 36 h,42h, 48h, using NRS. NRS score more than 4 will be treated as
breakthrough pain and injection fentanyl
(0.5 mcg/kg) will be administered intravenous as rescue analgesic. Time
at which first rescue analgesia is demanded by the patient will also be
recorded.
|