| CTRI Number |
CTRI/2022/01/039069 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
30/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the potency of pain relief provided by the nerve block given with two drugs under ultrasound guidance in patients who have thigh bone fracture before positioning them for spinal anaesthesia. |
|
Scientific Title of Study
|
To study the efficacy of ultrasound guided fascia iliaca compartment block with bupivacaine and dexmedetomidine for positioning before spinal anaesthesia in fracture femur patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sahana S |
| Designation |
Post graduate |
| Affiliation |
DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore KARNATAKA 560045 India |
| Phone |
7483107484 |
| Fax |
|
| Email |
sahana.suresh7@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Harsoor S S |
| Designation |
Head of the department |
| Affiliation |
DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore KARNATAKA 560045 India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sahana S |
| Designation |
Post graduate |
| Affiliation |
DR. B. R. AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG Halli, Bengaluru
Bangalore KARNATAKA 560045 India |
| Phone |
7483107484 |
| Fax |
|
| Email |
sahana.suresh7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr B R Ambedkar Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Sahana S |
| Address |
OT complex, 1st floor, Department of anaesthesiology, Dr B R Ambedkar Medical College and Hospital, KG halli, Bengaluru - 560045 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sahana S |
DR B R Ambedkar Medical College and Hospital |
OT complex, 1st floor, Department of Anaesthesiology, Dr B R Ambedkar Medical College and Hospital,KG Halli, Bengaluru Bangalore KARNATAKA |
7483107484
sahana.suresh7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Dr B R Ambedkar Medical College and Hospital |
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 |
| Intervention |
Dexmedetomidine |
Fascia iliaca compartment block is generally given with only a local anaesthetic agent. As an intervention, an adjuvant, dexmedetomidine is added along with local anaesthetic agent with a dosage of 0.5 mcg/kg and observed for ease of positioning the patient for spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for surgeries for femur fracture. American Society of Anaesthesiologists (ASA) class 1 and 2 patients. |
|
| ExclusionCriteria |
| Details |
Patients with history of kown allergy to bupivacaine or dexmedetomidine, pregnancy and lactation, pre-existing neurological conditions, alcoholism, drug abuse, psychological or other emotional problems that are likely to invalidate the informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain score in terms of visual analogue scale and numerical rating scale of lesser than or equal to 3 |
20 minutes after fascia iliaca compartment block, during positioning for spinal anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess the sedation in terms of Ramsay Sedation Score |
perioperative period |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
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)
|
01/01/2022 |
| 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
|
Lower limb fractures like fracture femur
pose a challenge to anesthesiologists in positioning the patients for spinal
anesthesia. It is often difficult because of excruciating pain. This also
presents difficulty in administration of spinal anesthesia because of inappropriate
position of the patient.
Hence, there is a need to provide good
pain relief to such patients in order to facilitate appropriate positioning for
spinal anesthesia. This also provides comfort to the patient and reduces
stress response because of pain relief.
Advantages of fascia iliaca compartment
block (FICB) are that, it is inexpensive and can be easily administered using
anatomical landmarks to provide perioperative analgesia in patients with
fracture femur. Local anesthetic agent like bupivacaine has been introduced as
it is potent and long acting which offers prolonged anesthesia with post-operative
analgesia. Dexmedetomidine has been added as an adjuvant to local anesthetic
agent in various blocks to increase the efficacy.
Therefore, ultrasound guided FICB is
administered as it has better accuracy compared to landmark technique. FICB is
administered with Bupivacaine and Dexmedetomidine. VAS and NRS scores are noted
before FICB and during positioning the patient for spinal anaesthesia. |