| CTRI Number |
CTRI/2024/09/074454 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Comparing three Types of Pain Relief Techniques After Hip Replacement Surgery Done with Spinal Anesthesia |
|
Scientific Title of Study
|
Comparison between 3 inter-fascial plane blocks on the postoperative analgesia in patients undergoing hip arthroplasty under spinal anesthesia |
| 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 Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Tehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,
Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Tehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,
Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute of Orthopedics and Tehabiliation |
| Address |
operation theatre complex, Second floor, Department of Anesthesiology,
Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune MAHARASHTRA 411005 India |
| Phone |
8484914584 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Hospital 11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,
India |
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
11/12 Thube Park, 16, Shivajinagar, Pune – 411005 Maharashtra,
India |
| 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 Institute of Orthopedics and Rehabiliation |
Department of Anesthesiology,
Operation theater, Second floor,
Sancheti Hospital 11/12 Thube
Park, 16, Shivajinagar, Pune –
411005 Maharashtra, India Pune
MAHARASHTRA
Pune
MAHARASHTRA Pune MAHARASHTRA |
8484914584
sdiwan1965@gmx.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Erector Spinae Plane Block |
An injection of local anesthetic into the plane deep to the erector spinae muscle, targeting nerves that can provide analgesia to the hip after spinal anesthesia |
| Intervention |
Fascia iliaca block
|
An injection of local anesthetic near the fascia iliaca to block the femoral nerve and other nerves supplying the hip region after spinal anesthesia.
|
| Comparator Agent |
Quadratus lumborum block |
An injection of local anesthetic near the quadratus lumborum muscle to block nerves that supply sensation to the hip area after spinal anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults of either gender aged between age between 18- and 80-years undergoing Hip arthroplasty under spinal anesthesia
American Society of Anesthesiologists (ASA) physical status I to III
|
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy, sepsis, hepatic or renal failure
allergy to local anesthetic (LA)
Patients with history of prior arthroplasty of the inguinal or suprainguinal area, pregnancy
Patients having opioids previously
Inability to consent to the study
Patients with pre-existing neuropathies
Patients with local infection around the needle site
Revision Arthroplasty
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to first rescue opioid in postoperative period |
first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post-operative pain scores, total 24-hour opioid requirements, opioid-related side effects & duration of stay among two groups
|
pain scores at 0 2 4 8 & 24 hours
total morphine consumption after 24 hours
side effcets at 0 2 4 8 & 24 hours
time to discharge after surgery once |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Total hip arthroplasty (THA) is a common surgical procedure
that improves the health-related quality of life and functional status of
patients. However, it is often associated with significant
postoperative pain. This pain may decrease mobility, increase the risk of
venous thromboembolism, impair rehabilitation, and delay recovery. Therefore, adequate postoperative pain
analgesia after THA is essential.
Regional anesthesia (RA) helps us to provide good pain
management and recovery in hip arthroplasty. Central neuraxial
blocks and general anesthesia have been the primary methods for anesthesia
during hip arthroplasty. We have a wide range of peripheral nerve blocks
(PNB) that have been seen with better outcomes in hip arthroplasty and
significantly reduced complications in most outcome categories, such as
cardiac, pulmonary, respiratory failure, and cognitive dysfunction
complications.3 Newer approaches, such as quadratus lumborum block (QLB), suprainguinal
fascia iliaca block (SIFIB), pericapsular nerve group (PENG) block and lumbar
erector spinae block (ESPB) have also been described recently. Peripheral
nerve blocks (PNBs) block the lumbar or sciatic nerve plexus after they exit
the spinal column. The lumbar plexus innervates the skin dermatomes and femoral
component for hip procedure, while the sciatic nerve plexus covers the
acetabular innervation. These more distal approaches result in unilateral or no
blockade of the sympathetic chain, resulting in lesser hemodynamic instability,
neurological complications, or motor blockade post-arthroplasty.
US-guided SIFIB has been used as a reliable
analgesic option for hip arthroplasty. SIFIB may lead to decreased
motor strength of the surgical limb, thereby hindering postoperative
mobilization and delaying discharge after outpatient hip Arthroplasty.
PENG selectively targets the
articular branches of the femoral and accessory obturator nerves while sparing
their motor components. The
PENG block is an easy regional technique
to perform in the supine position with motor-sparing benefits. QLB has also
been shown to provide good postoperative analgesia after hip arthroplasty. Lumbar erector spinae plane block (ESP) block is an
upcoming anaesthetic modality for hip surgeries. It is a relatively safe
technique, easy to perform, and associated with a lower risk of damage to
surrounding nerves and vessels due to the USG based bony landmarks for the
procedure and inadvertent intravascular injection. It can be given safely in
anticoagulated patients or when spinal epidural is contraindicated. The large
volume of local anesthetic deposited in the interfacial plane spreads to the
lumbar plexus, along with spread to the L4-L5 nerve roots, blocking the sacral
plexus as well. Both continuous and single-shot
lumbar ESP blocks have been proven to be promising analgesic alternatives in
studies for reducing opioid consumption and ensuring early ambulation after hip
surgeries.
Utilizing regional anesthesia helps
to limit the use of opioids. However, which technique is best has yet to be
determined.
In
this randomized trial, we will compare four inter-fascial plane blocks, i.e., PENG, SIFI, QL3 and Lumbar ESP on
the postoperative analgesia in patients undergoing hip arthroplasty under
spinal anesthesia. |