CTRI Number |
CTRI/2020/09/027893 [Registered on: 18/09/2020] Trial Registered Prospectively |
Last Modified On: |
12/09/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparing two different techniques in providing pain relief for better positioning of patient while performing injection at the back of spine in patients undergoing hip fracture surgeries |
Scientific Title of Study
|
A Randomized Control Study To Compare The Efficacy Of Pre-Emptive Ultrasound Guided Fascia Iliaca Compartment Block With Pericapsular Nerve Group Block For Positioning Of Spinal Anaesthesia In Hip Fracture Surgeries |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Parameshwaran M |
Designation |
Post Graduate Student |
Affiliation |
SRM Medical College Hospital And Research Centre |
Address |
Room Number 1606 ANESTHESIA DEPARTMENT SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram
Kancheepuram TAMIL NADU 603203 India |
Phone |
9994613023 |
Fax |
|
Email |
daredoparam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Parameshwaran M |
Designation |
Post Graduate Student |
Affiliation |
SRM Medical College Hospital And Research Centre |
Address |
Room Number 1606 ANESTHESIA DEPARTMENT SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram
Kancheepuram TAMIL NADU 603203 India |
Phone |
9994613023 |
Fax |
|
Email |
daredoparam@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Karthik K |
Designation |
Associate Professor |
Affiliation |
SRM Medical College Hospital And Research Centre |
Address |
DEPARTMENT OF ANAESTHESIOLOGY SRM Medical College Hospital And Research Centre SRMIST Potheri Kancheepuram
Kancheepuram TAMIL NADU 603203 India |
Phone |
7904412483 |
Fax |
|
Email |
karthikkrishnamoorthy1981@gmail.com |
|
Source of Monetary or Material Support
|
SRM Medical College Hospital And Research Centre, SRMIST, Potheri,kattankulathur.kancheepuram District-603203 |
|
Primary Sponsor
|
Name |
SRM Medical College Hospital And Research Centre |
Address |
SRMIST SRM Nagar Potheri
|
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 Parameshwaran M |
SRM Medical College Hospital And Research Centre |
Room Number 1606
DEPARTMENT OF ANAESTHESIOLOGY Kancheepuram TAMIL NADU |
9994613023
daredoparam@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
SRM Medical College Hospital And Research Centre. |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Fascia Iliaca Compartment Block |
30 ml of 0.5% ropivacaine Is Injected Below The Fascia Iliaca Plain Using Ultrasound |
Intervention |
Pericapsular Nerve Group Block |
20 ml of 0.75% Ropivacaine Is Injected In The Interfacial Plain Aiming To Block Articular Branches Supplied By Femoral Obturator And Accesory Obturator Nerves Using Ultrasound |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
75.00 Year(s) |
Gender |
Both |
Details |
ASA 1 2 3
Patients admitted for elective and emergency hip fracture surgeries under spinal anaesthesia.
|
|
ExclusionCriteria |
Details |
patient refusal,
any contra indication for spinal anaesthesia,
infection at the site of block,
allergy to local anaesthetic drugs or other medications used in the study,
coagulopathy.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Comparison of quality of positioning for spinal anaesthesia for hip fracture surgeries |
From starting until end of performing spinal anesthesia |
|
Secondary Outcome
|
Outcome |
TimePoints |
1)To evaluate the duration of post-operative analgesia
2)Requirement of post-operative analgesics for 24 hrs.
|
Till 24 hrs Post Operatively |
|
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)
|
28/09/2020 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Patients who met the inclusion criteria will be randomly allocated into two groups, Group A and Group B with 30 in each group based on computer generated random envelope method. Group F patients will receive 30 ml of 0.5% Ropivacaine for FICB (Fascia iliaca compartment block) and Group P patients will receive PENG block. All patients will receive premedication with tablet alprazolam 0.5 mg per oral 2 hours before shifting to the operating theatre. Once the patient is shifted to premedication room, the patient’s vitals were monitored using pulse oximetry, NIBP and ECG. After taking proper aseptic precautions, under ultrasound guidance, Fascia Iliaca Compartment Block will be given using 30 ml of 0.5% ropivacaine on group F patients. Group P patients will receive PENG Block with 20 ml of 0.75% Ropivacaine. After 15 minutes of administration of the block in both the groups, the patients will be shifted to the operation theatre and spinal anaesthesia will be given using 3 ml of 0.5% bupivacaine (heavy). Intra-operatively patient will be monitored for heart rate, blood pressure, oxygen saturation, input and output monitoring. All the patients will be postoperatively monitored in the recovery room for 2 hours and then shifted to PACU . Post-operative pain will be assessed by visual analog scale (VAS). Supplementary analgesics i.e. Inj. Paracetamol 1000mg(IV) will be given if the patient had elicited a VAS score of 3 to 5 and Inj. Tramadol 100 mg (IV) will be given if the patient has a VAS score of more than 5. Total consumption of Paracetemol and Tramadol for 24 hours will be noted. Patient positioning score during spinal anaesthesia was assessed depending on the patient’s sitting comfort during administration of spinal anaesthesia. 0 – not satisfactory, 1 – satisfactory, 2 – Good, 3 – Optimal. VISUAL ANALOG SCALE: The pain will be assessed by visual analog scale (VAS), measured at rest. 0 = no pain at all 1–2 = mild pain intensity 3–5 = moderate pain intensity 6–8 = severe pain intensity 9–10 = worst pain ever felt. The duration of postoperative analgesia is defined as the time taken from the completion of FICB and PENG block to the first request for postoperative analgesia (VAS > 3). If the patient has VAS of 3 to 5 then Inj. Paracetamol 1g IV will be given and for VAS>5, inj tramadol will be given. The total consumption of tramadol and paracetamol will be noted. The occurrence of any adverse effects like nausea, vomiting, itching and respiratory depression will be noted and treated accordingly |