| CTRI Number |
CTRI/2023/06/054534 [Registered on: 28/06/2023] Trial Registered Prospectively |
| Last Modified On: |
26/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational |
| Study Design |
Other |
|
Public Title of Study
|
Nerve Block as a Technique of Anaesthesia For Hip Surgeries as an Alternative to Spinal/General Anaesthesia |
|
Scientific Title of Study
|
Non-Neuraxial Regional Anaesthesia Technique for Hip Surgeries- A Prospective Observational Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Varsha Peesara |
| Designation |
Academy of Regional Anaesthesia Fellow |
| Affiliation |
AIG Hospitals , Gachibowli, Hyderabad |
| Address |
Department of Anaesthesia and Perioperative Medicine and Critical Care, 4th Floor OT complex, AIG Hospitals, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8308346829 |
| Fax |
|
| Email |
varshapeesara85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Varsha Peesara |
| Designation |
Academy of Regional Anaesthesia Fellow |
| Affiliation |
AIG Hospitals , Gachibowli, Hyderabad |
| Address |
Department of Anaesthesia and Perioperative Medicine and Critical Care, 4th floor OT complex, AIG Hospitals, Gachibowli, Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8308346829 |
| Fax |
|
| Email |
varshapeesara85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Varsha Peesara |
| Designation |
Academy of Regional Anaesthesia Fellow |
| Affiliation |
AIG Hospitals , Gachibowli, Hyderabad |
| Address |
Department of Anaesthesia and Perioperative Medicine and Critical Care, 4th floor ,OT complex, AIG hospitals , Gachibowli , Hyderabad
Hyderabad
TELANGANA
500032
India |
| Phone |
8308346829 |
| Fax |
|
| Email |
varshapeesara85@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIG Hospitals , Gachibowli, Hyderabad |
|
|
Primary Sponsor
|
| Name |
AIG Hospitals |
| Address |
Department of Anaesthesia and Perioperative Medicine and Critical Care, 4th floor OT complex, AIG Hospitals, Gachibowli, Hyderabad, 500032 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Varsha Peesara |
AIG Hospitals |
Department of Anaesthesia and Perioperative Medicine and Critical Care, 4th Floor OT complex,AIG hospitals, Gachibowli, Hyderabad, Telangana, 500033
Hyderabad
TELANGANA |
8308346829
varshapeesara85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian Institute of Gastroenterology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients posted for Hip Surgeries |
| Patients |
(1) ICD-10 Condition: M970||Periprosthetic fracture around internal prosthetic hip joint, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients posted for Elective and Emergency Hip Surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal, Coagulopathy, Local site infections, Age less than 18years, Bilateral Hip Surgeries, Local anesthestics allergy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve complete sensory & motor blockade for the surgery using Lumbar & Sacral plexus block |
Upto 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quantify the conversion rate from lumbar & sacral plexus to conventional techniques, To know the time taken for the onset of sensory and motor block, to know the duration of motor block , to analyse various outcome like postoperative pain, postoperative cognitive dysfunction, opioid consumption , time taken for postoperative mobilisation, complications associated with the procedure |
Upto 24 hours |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
10/07/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip surgeries are routinely done under General or Spinal Anesthesia, But in High Risk Geriatric patients these techniques carry more risk as they have multiple medical issues and are often on medications that may pose complications in the perioperative periods. Hence Peripheral Nerve blockade using Lumbar and Sacral plexus block produces Complete anaesthesia for the ipsilateral lower limb with stable hemodynamics and excellent postoperative analgesia. In this Prospective Observational Study, We aim to use Lumbar and Sacral plexus block as a sole anaesthetic technique for Hip surgeries to avoid complications associated with the conventional techniques. After taking written informed consent , patients are taken in the perioperative area with all the standard monitors attached and sedated mildly with Inj Midalozalam 1-2mg , positioned on the lateral decubitus side. Ultrasound and Peripheral Nerve stimulator guided Lumbar and Sacral Plexus block will be performed on the limb that needs to be operated . Time taken for the onset of sensory and motor block , duration of the block, time taken for postoperative mobilisation , complications associated with the procedure will be noted. Incomplete motor block cases will be converted to General or Spinal anaesthesia. |