| CTRI Number |
CTRI/2021/07/035052 [Registered on: 22/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/07/2021 |
| 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 study to know whether injection paracetamol is effective in decreasing pain as compared to femoral nerve block( injection for nerve carrying pain from leg) during patient positioning for central neuraxial block(injection to back of patient for pain relief) in leg bone fracture surgeries
|
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Scientific Title of Study
|
Comparison of efficacy of femoral nerve block versus intravenous paracetamol in providing analgesia during positioning for central neuraxial block in patients posted for surgical fixation of femur fractures- a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srinivasan S |
| Designation |
Assosciate professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaesthesiology and criticalcare
JIPMER
Dhanvanthri nagar,Gorimedu
puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9626493045 |
| Fax |
|
| Email |
jipmersrinivasan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sharoon shah p s |
| Designation |
Juniour resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaesthesiology and criticalcare
JIPMER
Dhanvanthri nagar,Gorimedu
puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8589803069 |
| Fax |
|
| Email |
itsmesharoon@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharoon shah p s |
| Designation |
Juniour resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of anaesthesiology and criticalcare
JIPMER
Dhanvanthri nagar,Gorimedu
puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8589803069 |
| Fax |
|
| Email |
itsmesharoon@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
JIPMER
Dhanvanthri nagar,Gorimedu
puducherry, 605006 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Srinivasan S |
Jawaharlal institute of post graduate medical education and research |
Emergency OT and elective OT,2nd floor,emergency block, Department of anaesthesia and critical care
JIPMER
Dhanvanthri nagar,Gorimedu
puducherry, 605006
Pondicherry
PONDICHERRY |
9626493045
jipmersrinivasan@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Patients are injected with intravenous paracetamol before positioning for central neuraxial block |
Patients of age above 18 years,and classified as ASA physical status 1-3, undergoing surgery for femur fracture fixation are injected with intravenous paracetamol(one gram) one hour before positioning for central neuraxial block. |
| Comparator Agent |
Patients are provided with femoral nerve blockage before positioning for central neuraxial block. |
Patients of age above 18 years,and classified as ASA physical status 1-3, undergoing surgery for femur fracture fixation are given femoral nerve block before positioning for central neuraxial blockage. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age above 18 years,and classified as ASA physical status 1-3, undergoing surgery for femur fracture fixation |
|
| ExclusionCriteria |
| Details |
Allcontraindications for central neuraxial block
like localised sepsis,allergy to
drugs,raised intracranial
pressure,coagulopathy ,pregnancy and
hepatic or renal impairment. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Comparison of analgesic efficacy of femoral nerve block versus intravenous paracetamol during positioning for central neuraxial block in patients with femur fractures
between group P(intravenous paracetamol) and group F( femoral nerve blockage ) using visual analogue pain Scale (VAS score).
|
VAS scores will be assessed during patient positioning for central neuraxial blockage |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of the quality of patient position in likerts scale as perceived by the anaesthesiologist performing the central neuraxial block between both the groups. |
During patient positioning for central neuraxial blockage |
| Comparison of the rescue fentanyl dose used during the procedure to alleviate the pain in both the groups. |
if patient still has VAS score greater than 4 during positioning even after intravenous paracetamol(group P) or femoral nerve block(group F) |
| Comparison of the total time taken for performance of the block in both the groups. |
Time taken for central neuraxial block will be compared |
| Comparison of hemodynamic parameters(pulse rate and blood pressure)during the positioning of the patient in both groups. |
During patient positioning for central neuraxial blockage |
|
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Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
01/08/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
The data generated will be used for research and publication purpose. |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Central neuraxial
blocks (combined spinal epidural blocks) are one of the preferred techniques for
anaesthetising patients posted for orthopaedic surgeries for fracture femur fixation. Positioning these patients for neuraxial blockade
however is rendered very difficult due to the pain of fracture. Suboptimal positioning sometimes leads to prolonged
duration and in some cases lead to block failure as well. It also
causes severe pain and discomfort to the patients which may result in haemodynamic
distubances including tachycardia and hypertension. Femoral nerve block has been shown to be an effective
method of analgesia for spinal positioning in patients with fractured femoral shaft
and proximal femur fractures. Several drugs
including opioids have also been employed for this purpose and had been compared
with femoral nerve block.but use of opioids has disadvantages of causing drowsiness
and respiratory depression. Paracetamol is a nonopioid analgesic and is one of the
commonly used analgesic agent that had been used in various acute pain conditions
including postoperative pain .Intravenous paracetamol is the formulation which is
preferred in the perioperative period due to its increased bioavailability and is
almost safe in all age groups and is easily
accessible. The main advantage of paracetamol is that it is easily
administrable as compared to blocks.In this study we like to compare the efficacy
of femoral nerve block and intravenous paracetamol given in the preoperative period,
in improving conditions of positioning required for cental neuraxial block. Even
though paracetamol has been studied as an analgesic in intraoperative and postoperative
period, its usefulness in the preoperative period for the purpose of providing analgesia
for patient positioning for central neuraxial block in patients with femur fracture
has not been studied. Intravenous
paracetamol if it is found to be effective in providing adequate analgesia and providing
optimal conditions for patient positioning
during performance of central neuraxial block can be used routinely for this purpose
preoperatively in patients with fracture femur posted for surgery
|