| CTRI Number |
CTRI/2025/02/080817 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| 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
|
Comparison of pain relief due to two different injections in combination with an injection around hip bone in patinets with hip fractures |
|
Scientific Title of Study
|
A comparative study on the efficacy of PENG block with either supra-inguinal fascia iliaca block or circum-psoas block for postoperative analgesia in elderly patients undergoing surgery for proximal hip fractures |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Sancheti Hospital, Pune |
| Address |
Department of Anesthesiology, Sancheti Hospital, Pune
Pune MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Sancheti Hospital, Pune |
| Address |
Department of Anesthesiology, Sancheti Hospital, Pune Department of Anesthesiology, Sancheti Hospital Pune MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sandeep Madhusudan Diwan |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Sancheti Hospital, Pune |
| Address |
Department of Anesthesiology, Sancheti Hospital, Pune
MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan14@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
16, Shivajinagar, Pune, Maharashtra 411005 |
| 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 Sandeep Diwan |
Sancheti Hospital |
Department of Anaesthesia,
16, Shivajinagar Pune MAHARASHTRA |
8484914584
sdiwan14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SIOR |
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 |
Circumpsoas block is the comparator |
Under due asepsis, a linear array high-frequency ultrasound (US) probe with 13-6 MhZ (Fujifilm Sonosite Inc, USA) will be deployed below the inguinal ligament and the psoas tendon, iliacus muscle and fascia, femoral nerve, and femoral artery will be identified in a transverse scan. |
| Intervention |
Supra-inguinal fascia iliaca block is the intervention performed |
Intraoperative S-FICB will be performed by means of the suprainguinal technique after detection of the bow-tie sign formed by the internal oblique and sartorius muscles. A total of 30 mL of 0.2% ropivacaine with clonidine 15mcg will be injected under the abdominal muscle to maintain the spread using an in-plane technique. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
proximal femur fracture surgery (intertrochanteric, neck of femur and subtrochanteric fractures) and consenting for the trial |
|
| ExclusionCriteria |
| Details |
inability or refusal to sign informed consent, younger than 18 years, BMI greater than 35 kg/m2, intolerance to any of the drugs used in the study, a history of hepatic or renal insufficiency, coagulopathy, using chronic analgesic drugs; having additional illnesses, including liver or kidney diseases, neurological deficits in the lower extremities and illnesses that interfered with communication skills such as dementia or mechanical ventilation requirement. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24-hrs opioid consumption |
24-hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Time to the first analgesia
2. Resting NRS scores at 0, 2, 8, 12, 24 hrs
3. Dynamic NRS scores at 0,2,8,12,24 hrs
4. Number of patients with NRS 0 at 6hrs.
5. Adverse effects in the 2 groups
|
0,2,8,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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="0" Months="6" 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
|
The
fascia iliaca block is a commonly used compartment block for cutaneous
analgesia for hip surgery. The hip joint is innervated by branches of the
femoral nerve (FN), obturator nerve (ON), and sciatic nerve (SN). The lateral
femoral cutaneous nerve (LFCN) should also be blocked if the surgical incision
extends to the lateral side of the thigh. The FN, ON, and LFCN are all part of
the lumbar plexus, implying that blocking the lumbar plexus is an elegant way
to provide postoperative analgesia for THA. The fascia iliaca compartment block
(FICB) can be regarded as an anterior approach of the lumbar plexus. This block
anesthetizes the lateral femoral cutaneous nerve but has reported failure rates
of 10% to 37%. Moreover, a recent study failed to demonstrate the benefit
of a “classic†transverse FICB at the level of the FN for postoperative
analgesia after hip arthroplasty. Supra-inguinal fascia iliaca (SIFI) block
is a novel regional anaesthesia technique that was first described by Hebbard
et al. in 2015 as an alternative technique to the classic infrainguinal fascia
iliaca block on the presumption that it will provide a wider local anaesthetic
spread and better coverage of the lateral femoral cutaneous nerve. The
course of the lateral femoral cutaneous nerve below the inguinal ligament is
variable as opposed to consistent above the inguinal ligament in the pelvis.
The authors used a supra-inguinal ultrasound-guided technique and placed local
anaesthetic directly into the iliac fossa and found that it leads to extensive
fluid spread throughout the iliac fossa. They described consistent staining of
the femoral nerve and lateral femoral cutaneous nerve in their cadaveric dye
study. Subsequently, many clinical studies demonstrated its analgesic efficacy. One study comparing lumbar plexus block versus SIFI block for total hip
arthroplasty found that SIFI block provided equivalent analgesic efficacy and
longer duration of analgesia.
Circumpsoas
block (CPB) is a recently described block which is an anterior myofascial plane
block for lumbar plexus elements. In an attempt to improvise the analgesia
in patients with femoral fractures,
local anesthetic was deposited deep to anterior psoas fascia under
ultrasound guidance to block lumbar plexus elements which emerge lateral,
anterior, and medial to the psoas major muscle. . Clinical and computed
tomography contrast studies revealed that a continuous CPB infusion with a
catheter provided a reliable block of the lumbar plexus elements. No adverse
were events noted. Hence, it is implied that US guided CPB is a reliable
technique for managing postoperative pain after surgery of femur fractures.
Since SIFI block does not provide coverage for obturator nerve, we hypothesized
that PSB would provide a superior pain relief compared to SIFI block. At
present, no study has compared these two regional anesthesia techniques. Hence,
we decided to compare the two techniques for postoperative analgesic efficacy. |