| CTRI Number |
CTRI/2024/09/073817 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Ultrasound-Guided Nerve Block and Combined Foot and Ankle Nerve Block for pain relief after foot surgery |
|
Scientific Title of Study
|
A comparative study to evaluate the effectiveness of ultrasound-guided popliteal nerve block and a combination of ultrasound guided interfacial plane foot block with sural nerve block on postoperative analgesia in patients undergoing calcaneal surgery. A Randomized Controlied 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 |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
Operation Theatre Complex, Second floor, Department of Anesthesiology,Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
Operation Theatre Complex, Second floor,Department of Anesthesiology,Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| Fax |
|
| Email |
sdiwan1965@gmx.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Diwan |
| Designation |
Senior Consultant |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabiliation |
| Address |
Operation Theatre Complex, Second floor, Department of Anesthesiology,Sancheti Hospital
Pune
MAHARASHTRA
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9823029328 |
| 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 Rehabilitation |
Department of Anesthesiology,Operation theater, Second floor,Sancheti Hospital 11/12 ThubePark, 16, Shivajinagar, Pune –411005 Maharashtra, India
Pune
MAHARASHTRA |
8484914584
sdiwan1965@gmx.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe, Sancheti Institute of Orthopedics and Rehabilitation, e |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M97-M97||Periprosthetic fracture around internal prosthetic joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 2: Interfacial plane block with sural nerve block |
patients will receive Interfacial plane block with sural nerve block with 10 ml LA. The block will be give once before incision and takes about 10-15 min
|
| Intervention |
Group-1 Ultrasound-guided Popliteal Nerve Block
|
patients will be randomly allocated to receive Popliteal nerve block with 10 ml of local anesthetic (LA). The block will be give once before incision and takes about 10-15 min |
|
|
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 with American Society of
Anesthesiologists (ASA) physical status I to III undergoing calcaneal surgery |
|
| ExclusionCriteria |
| Details |
1. Patients with coagulopathy, sepsis, hepatic or renal failure 2. allergy to local anesthetic (LA) 3.Inability to consent to the study 4. Patients having opioids previously 5. Patients with pre-existing neuropathies 6. Patients with local infection around the needle site |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The times of rescue analgesia and the adverse reactions caused by the analgesics such as
pruritus, nausea and vomiting will be recorded.
|
time to anlgesia requirement when patient demandsin first 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The visual assessment scale (VAS) was used to assess the pain of patients immediately after discharge from the operating room (T1), at 1st (T2), 2nd (T3), 4th (T4), 8th (T5),2th (T6), and 24th (T7) hour after operation.
2.The satisfaction of the surgeon and patients the satisfaction concerning the block received on a Likert scale of 1-5 ( 1: least likely and 5: most likely)
3.Total tramadol consumption in 24 hours
|
VAS will be recorded at time 0, 1 h, 2 h,4h, 8h, 12 h and 24 h
total tramadol will be recorded once at 24 h
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/10/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Calcaneal
fracture is a common foot and ankle injury and is associated with severe and
difficult-to-manage pain. For patients with calcaneal fractures, surgery is generally the mainstay
of treatment to relieve pain and correct foot dysfunction.
Surgery can
result in significant postoperative pain result in significant postoperative pain for at least
24 hours and
if this postoperative pain is not managed well then it may lead to inactivity and
possible complications like hematoma and wound dehiscence. The
surgery is often done under spinal anesthesia, but its effect is limited and
patients often complain of pain after a few hours.We hypothesized that the interfacial
plane block and sural nerve combination may be like a popliteal nerve block for
calcaneal surgery.This investigator initiated
single-blinded randomized control trial will be conducted on patients who will
be admitted for calcaneal surgery at Sancheti hospital, Pune, India. This trial will be
started after getting the CTRI registration and Ethics committee
approval from institute.
Written informed consent will be obtained from the eligible patients fulfilling
the inclusion criteria. After obtaining written informed consent, we will
enrol 60 patients undergoing calcaneal surgery.
We
will explain how to report pain using the 11-point numerical rating
scale (NRS), with ‘0’ corresponding to no pain and ‘10’ being the worst possible
pain. Standard fasting guidelines will be followed for all. Outcome
measures
1. The times of rescue analgesia and the adverse
reactions caused by the analgesics such as pruritus, nausea and vomiting were
recorded.
2.
The visual
assessment scale (VAS) was used to assess the pain of patients immediately
after discharge from the operating room (T1), at 1st (T2), 2nd (T3), 4th (T4), 8th
(T5), 12th (T6), and 24th (T7) hour after operation.
3.
The satisfaction
of the surgeon and of patients the satisfaction with respect to the block
received on Likert scale of 1-5 ( 1:
least likely and 5: most likely)
4. Total tramadol consumption in 24 hours
|