| CTRI Number |
CTRI/2022/12/048119 [Registered on: 14/12/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2022 |
| 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
|
A study to compare the pain relief achieved after giving a nerve block (Pericapsular nerve group block) and an Intravenous Injection of a medicine (Tramadol) for performing the Anaesthetic procedure (Spinal and epidural anaesthesia) required for the surgery |
|
Scientific Title of Study
|
To compare the analgesic effect of ultrasound guided Pericapsular Nerve Group block versus intravenous tramadol on hip fracture patients for performing central neuraxial blockade - A double blinded Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RC/2022/52, Version 1, 28/09/2022 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anuprabha M |
| Designation |
MD Anaesthesiology |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
No.1, Third cross, Pattammal nagar, Mudaliarpet, Puducherry
Pondicherry Institute of Medical sciences, Village No.20, Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY
6056604
India |
| Phone |
8056182767 |
| Fax |
|
| Email |
anuprabha27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arish BT |
| Designation |
MD Anaesthesiology |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical sciences, Village No.20, Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9791853400 |
| Fax |
|
| Email |
ajstyle.bt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuprabha M |
| Designation |
MD Anaesthesiology |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
No.1, Third cross, Pattammal nagar, Mudaliarpet, Puducherry
Pondicherry Institute of Medical sciences, Village No.20, Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY
6056604
India |
| Phone |
8056182767 |
| Fax |
|
| Email |
anuprabha27@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical Sciences |
| Address |
Pondicherry Institute of Medical Sciences Village No.20, Kalathumettupathai, Ganapathichettikulam Kalapet, Puducherry 605014 |
| Type of Sponsor |
Private 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 Anuprabha M |
Pondicherry Institute of Medical Sciences |
Village No.20, Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY |
8056182767
anuprabha27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee |
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 |
Pericapsular Nerve Group Block |
Pericapsular Nerve Group Block on the side of affected hip joint under ultrasound guidance |
| Comparator Agent |
Tramadol |
Intravenous tramadol 1mg/kg body weight |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with fractures around the hip joint (Neck of femur fracture, intertrochanteric fracture, isolated trochanteric fracture, subtrochanteric fracture, acetabular fracture) undergoing fracture correction and patients undergoing total hip replacement surgeries,
hemiarthroplasty in Pondicherry Institute of Medical Sciences
2. Elective procedure
3. Patients of age between 18 to 90 years
4. Male and Female
5. ASA Physical status I, II, III (American Society of Anaesthesiologist)
6. Surgery under central neuraxial blockade |
|
| ExclusionCriteria |
| Details |
1. Altered mental status.
2. Coagulopathy
3. Allergy for local anaesthetics / opioids
4. Contraindications for central neuraxial blockade and nerve blocks
5. Patient on opioids for chronic pain
6. Resting NRS score less than 2
7. Puncture site infection |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic effect of ultrasound guided Pericapsular Nerve Group block versus intravenous tramadol by using Numerical Rating Scale (NRS) at rest post intervention in hip fracture patients for performing central neuraxial blockade. |
20 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. The pain using Numerical Rating Scale (NRS) at 15o passive straight leg raising test post intervention.
2. Patients sitting ability for central neuraxial blockade
3. Anaesthesiologist satisfaction for ease of performing central neuraxial blockade
4. The Haemodynamic parameters (Heart rate, Systolic Blood Pressure, Diastolic Blood
Pressure, Mean arterial pressure, Oxygen saturation)
5. The requirement of rescue analgesia |
20 mins |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the analgesic effect of ultrasound guided Pericapsular Nerve Group block versus intravenous tramadol on hip fracture patients for performing central neuraxial blockade - A double blinded Randomised Control Trial by Numerical Rating Scale for analysing the pain score at rest and 15 degree passive straight leg raising test |