| CTRI Number |
CTRI/2018/04/013332 [Registered on: 18/04/2018] Trial Registered Prospectively |
| Last Modified On: |
14/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of Ultrasound guided block of the pain carrying nerves and epidural anaesthesia for relieving postoperative pain in patients undergoing one-sidedl total hip replacement |
|
Scientific Title of Study
|
A randomised study comparing the efficacy of Ultrasound guided lumbar plexus block and epidural anaesthesia for post operative analgesia in patients undergoing unilateral total hip replacement |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Harjit Sharma |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and Orthopedics, GMCH 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9779895656 |
| Fax |
|
| Email |
harjitsharma18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia and Orthopedics GMCH 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukanya Mitra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Government Medical College and Hospital Sector 32 Chandigarh |
| Address |
Department of Anaesthesia GMCH 32 Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital Sec-32 Chandigarh |
|
|
Primary Sponsor
|
| Name |
GMCH Chandigarh |
| Address |
Government medical college and hospital sector 32 Chandigarh |
| 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 Harjit Sharma |
GMCH 32 Chandiagrh |
Department of Anaesthesia and Orthopedics and Orthopedics
Chandigarh
CHANDIGARH |
9779895656
harjitsharma18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee GMCH 32 Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA 1 and 2, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dr Harjit Sharma |
Post graduate Junior Resident
Anaesthesia GMCH 32 Chandigarh |
| Comparator Agent |
Dr Harjit Sharma |
Postgraduate Junior Resident
Anaesthesia GMCH 32 Chandigarh |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) - I and II
Body Mass Index - 18-35 kg/m2
Patients scheduled for unilateral hip arthroplasty |
|
| ExclusionCriteria |
| Details |
ASA - III and IV
History of drug allergy to ropivacaine and/or fentanyl
Coagulation disorders
Local or systemic infection
Cardiovascular, respiratory or neurological illness
Uncontrolled diabetes mellitus
Aberrant anatomy of the landmarks
Patients having hemodynamic instability
Pregnancy and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean pain score measured by numeric rating scale over 48 hours study period |
1,4,12,24,36,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total postoperative analgesic consumption, motor power, patient satisfaction score and any adverse effects |
1,4,12,24,36,48 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
03/09/2018 |
| Date of Study Completion (India) |
30/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/11/2019 |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Its a randomised study comparing the efficacy of ultrasound guided lumbar plexus block and epidural anaesthesia for postoperative analgesia in patients undergoing unilateral total hip replacement. 25 patients will be given ultrasound guided lumbar plexus block and the control group (25 patients) will be given epidural anaesthesia according to previously mentioned inclusion and exclusion criteria. The study is being conducted at Government Medical College and Hospital Sector 32 Chandigarh. |