| CTRI Number |
CTRI/2017/08/009523 [Registered on: 29/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
25/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pre-operative pain relief in hip fractures- which is better? Femoral Nerve Block vs Fascia Iliaca Block |
|
Scientific Title of Study
|
To compare the analgesic efficacy and hemodynamic stability in femoral block and fascia iliaca block in pre-operative pain management of patients with hip fractures. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janani A M |
| Designation |
MBBS DNB Anaesthesia |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of Anesthesiology,
5th Floor Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
9944931128 |
| Fax |
|
| Email |
janani.murli@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Janani A M |
| Designation |
MBBS DNB Anaesthesia |
| Affiliation |
Ganga Medical Centre and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of Anesthesiology,
5th Floor Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
9944931128 |
| Fax |
|
| Email |
janani.murli@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr V M Balasubramani |
| Designation |
Chief, trauma intensive care |
| Affiliation |
Ganga Medical Center and Hospital |
| Address |
Ganga Medical Center and Hospital,
Department of Anesthesiology,
5th Floor Operation theater complex,
313 Mettupalayam Road Opposite Saibaba koil
Coimbatore TAMIL NADU 641043 India |
| Phone |
|
| Fax |
|
| Email |
vmbalasubramani@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Ganga Hospital,313 mettupalayam road, sai baba colony Coimbatore 641043 Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Ganga Medical Centre and Hospital |
| Address |
313, mettupalayam Road, Opp to Sai Baba Temple, Coimbatore- 641043 |
| 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 Janani Murli |
Ganga Hospital, Coimbatore |
Department of Orthopedic and Trauma, 5th floor preoperative room Coimbatore TAMIL NADU |
9944931128
janani.murli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patients having hip fractures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascia Iliaca block |
Fascia iliaca Nerve Block was performed using 0.25% bupivacaine (according to the weight 3mg/kg) with 8mg dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance and patients were assessed for 24 hours following nerve block for pain relief. |
| Intervention |
Femoral nerve block |
Femoral Nerve Block was performed using 0.25% bupivacaine (According to the weight 3 mg/kg) with 8mg Dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance and patients were assessed for 24 hours following nerve block for pain relief. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients with isolated hip fracture
2) Patients of ASA physical Status I, II and III
3) Patients who have not been subjected to other analgesics after the fracture
4) Patients who are oriented to give consent.
|
|
| ExclusionCriteria |
| Details |
1) Pathological and periprosthetic hip fractures
2) Patients allergic to local anesthetics
3) Recent vascular injury involving the lower limb
4) Bleeding diathesis, patients on anti-platelets
5) Patients who shall be taken up for surgery within 18 hours
6) Patients less than 18 years of age
7) Patients more than 90 years of age
8) Hemodynamically compromised patients
9) Non consenting patients / relative refusal for procedure
10) Patients in ASA physical status class IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score less than 3 |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Motor Blockade, Sensory Blockade, Duration, Rescue analgesia, Side effect |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/03/2014 |
| Date of Study Completion (India) |
10/08/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study comprised of hundred patients (50 in each group) of the
age group 18-90 years, of either sex, suffering from hip fracture categorized
under American Society of Anaesthesiologists (ASA) physical status I, II&
III, after the conditions of the inclusion and exclusion criteria were
satisfied. They were divided into 2 groups using the computerized randomization
technique as follows: Group A (N=50) Femoral Nerve Block was
performed using 0.25% bupivacaine (According to the weight) with 8mg
dexamethasone under combined ultrasonography and peripheral nerve stimulation
guidance and Group B (N=50) Fascia iliaca Nerve Block was
performed using 0.25% bupivacaine (according to the weight) with 8mg
dexamethasone under combined ultrasonography and peripheral nerve stimulation guidance.
The study aims to compare the onset, duration of sensory and motor block,
duration of analgesia, hemodynamic stability and need of rescue analgesia. The
aim of the study is to compare analgesic efficacy and hemodynamic stability in
femoral nerve block versus fascia iliaca block as pain management in hip
fractures during the pre-operative period, with objectives to
determine Time of onset and duration of sensory block, time of onset and
duration of motor block, Range and duration of analgesia, Efficacy of analgesia
using VAS assessment scale at rest and at movement and the number of rescue
analgesics required in these patients, Hemodynamic stability in terms of heart
rate, blood pressure, saturation for a period of 24 hours.
Result
of our study showed that in the pre- operative period, prolonged duration of
analgesia with better hemodynamic stability is better achieved in femoral nerve
block group than the fascia iliaca block group. Femoral nerve block
administration resulted in lower VAS both at rest and during passive hip
flexion of 15 degree, longer duration of sensory and motor block, Longer
duration of analgesia and decreased amount of rescue analgesics as compared to
fascia iliaca block. Though fascia iliaca block gives a better pain relief
during the first two hours longer and better pain control in given by femoral
block. Both the blocks provided good hemodynamic stability. Thus we conclude
that femoral nerve block is better than fascia iliaca block in pain management
pre-operatively for hip fractures, whereas fascia iliaca can be preferred just
before surgery for positioning and for pain relief during the surgical
incision. |