| CTRI Number |
CTRI/2019/12/022488 [Registered on: 23/12/2019] Trial Registered Prospectively |
| Last Modified On: |
12/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Spinal and Nerve block study for hip surgeries |
|
Scientific Title of Study
|
A comparative study of minidose bupivacaine–fentanyl spinal
anesthesia with or without fascia iliaca compartment block for hip 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 Loretta raj |
| Designation |
Assistant Professor |
| Affiliation |
Kanyakumari government medical college hospital |
| Address |
Department of Anaesthesiology, Kanyakumari medical college hospital, Asaripallam
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443151170 |
| Fax |
|
| Email |
lorettaraj1986@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Edward johnson |
| Designation |
Professor & HOD & Co-author |
| Affiliation |
Kanyakumari government medical college hospital |
| Address |
Department of Anaesthesiology, Kanyakumari medical college hospital, Asaripallam
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443392974 |
| Fax |
|
| Email |
edwardjohnson2310@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Loretta raj |
| Designation |
Assistant Professor |
| Affiliation |
Kanyakumari government medical college hospital |
| Address |
Department of anaesthesiology
kanyakumari government medical college hospital
asaripallam
Kanniyakumari
TAMIL NADU
629201
India |
| Phone |
9443151170 |
| Fax |
|
| Email |
lorettaraj1986@gmail.com |
|
|
Source of Monetary or Material Support
|
| Head of the Department
Department of Anaesthesiology
Kanyakumari government medical collge
Asaripallam |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
kanyakumari govt medical college hospital, Asaripallam |
| Type of Sponsor |
Government medical college |
|
|
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 Loretta raj |
Kanyakumari government medical college hospital |
Department of Anaesthesiology,
Kanyakumari govt medical college hospital,
Asaripallam
Kanniyakumari
TAMIL NADU |
9443151170
lorettaraj1986@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, kanyakumari government medical college hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M955||Acquired deformity of pelvis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascia Iliaca compartment block combined with Spinal anaesthesia |
30 ml of saline in fascia iliaca compartment block combined with 0.5% hyperbaric bupivacaine 5mg with 25 mcg of Fentanyl given through spinal anaesthesia. |
| Intervention |
Fascia iliaca compartment block combined with spinalanaesthesia |
30 ml of 0.25% Inj bupivacaine in fascia iliaca compartment block combined with 0.5% hyperbaric bupivacaine 5mg with 25 mcg of Fentanyl given through spinal anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA risk status PS I,II, III
2.Cases posted for hip surgeries
3.Written informed consent |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.ASA PS IV
3.Coagulopathies
4.Prolonged surgery more than 180 minutes
5.Cardiovascular instability
6.Infection at site of block
7.Allergy to opioids
8.Significant peripheral neuropathy affecting lower extremity
9.Previous femoral bypass surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Stability |
From preoperative period till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative VAS Score |
From the end of surgery till 12 hours postoperatively |
| Total Opioids dosage consumed. |
From the end of surgery till 12 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Aim & Objectives: To compare the intraoperative hemodynamic stability & post operative analgesic efficacy in mini dose bupivacaine -fentanyl spinal anaesthesia combined with fascia iliaca block for hip surgeries in geriatric population.
Methods: Geriatric patients coming for hip surgeries who meet the inclusion criteria were recruited, and randomly assigned into 2 groups . Group A- Ultrasound guided fascia iliaca compartment block performed with 30 ml of normal saline, epidural catheter is inserted in L2-L3 interspace (rescue anaestheisa) and unilateral spinal anaesthesia performed in lateral position with operative limb in dependent position with 0.5% bupivacaine 5 mg+ 25 mcg fentanyl in L3- L4 inter space. Group B- Ultrasound guided fascia iliaca compartment block performed with 30 ml of 0.25% bupivacaine, epidural catheter is inserted in L2-L3 interspace (rescue anaestheisa) and unilateral spinal anaesthesia performed in lateral position with operative limb in dependent position with 0.5% bupivacaine 5 mg+ 25 mcg fentanyl in L3- L4 inter space. HR,NIBP, MAP, SPo2 will be monitored continuously from the start of giving anaesthesia till the end of the surgery at an interval of 15 minutes. postoperative VAS scores and total dose of opioids consumed assesed upto 12 hours after surgery.
Expected outcome: Decreased post operative VAS scores and Opioid consumption dosage in Group B |