| CTRI Number |
CTRI/2022/04/042165 [Registered on: 26/04/2022] Trial Registered Prospectively |
| Last Modified On: |
25/04/2022 |
| 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
|
Comparing the two methods of analgesia for postoperative pain in patients undergoing total hip arthroplasty |
|
Scientific Title of Study
|
A Randomized controlled study comparing the efficacy of ultrasound guided continuous psoas subfascial block with continuous lumbar epidural blockade for postoperative analgesia in patients undergoing total hip arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRUTHIGA |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHEIA,
CHRISTIAN MEDICAL COLLEGE,
VELLORE
Vellore
TAMIL NADU
632002
India |
| Phone |
8903544236 |
| Fax |
|
| Email |
kiruthigaravi06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRRAHUL PILLAI |
| Designation |
ASSISSTANT PROFESSOR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIA,
CHRISTIAN MEDICAL COLLEGE,
VELLORE
DEPRTMENT OF ANAESTHESIA,
CHRISTIAN MEDICAL COLLEGE,
VELLORE.
Vellore
TAMIL NADU
632002
India |
| Phone |
9894460758 |
| Fax |
|
| Email |
cmcrahulpillai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KIRUTHIGA |
| Designation |
PG REGISTRAR |
| Affiliation |
CHRISTIAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHEIA,
CHRISTIAN MEDICAL COLLEGE,
VELLORE
Vellore
TAMIL NADU
632002
India |
| Phone |
8903544236 |
| Fax |
|
| Email |
kiruthigaravi06@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTIONAL - FLUID RESEARECH GRANT,CHRISTIAN MEDICAL COLLEGE, VELLORE |
|
|
Primary Sponsor
|
| Name |
CHRISTIAN MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIA,
CHRISTIAN MEDICAL COLLEGE,
VELLORE |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Kiruthiga |
DEPARTMENT OF ANAESTHESIA, CHRISTIAN MEDICAL COLLEGE, VELLORE |
DEPARTMENT OF ANAESTHESIA
Vellore
TAMIL NADU |
8903544236
kiruthigaravi06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CHRISTIAN MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (2) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (3) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, (4) ICD-10 Condition: 7||Osteopathic, (5) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous lumbar epidural blockade with local anaesthetic for postoperative analgesia |
To prove continuous psoas subfascial block is equally effective compared to continuous lumbar epidural blockade for postoperative analgesia in patients undergoing total hip arthroplasty. Pain scores will assessed every eighth hourly for the first 48 hours of postoperative period and functional recovery during the time of discharge |
| Intervention |
Ultrasound guided continuous psoas subfascial block with local anaesthetic for postoperative analgesia |
To prove continuous psoas subfascial block is equally effective compared to continuous lumbar epidural blockade for postoperative analgesia in patients undergoing total hip arthroplasty. Pain scores will be assessed eighth hourly for first 48 hours of postoperative period and functional recovery during the time of discharge |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing unilateral and bilateral total hip arthroplasty,
ASA I,II,stable ASA III patients,
Age>18 years |
|
| ExclusionCriteria |
| Details |
ASA IV,
Age<18 years,
Patients with deranged coagulation profile,
Allergy to medication which is included in the protocol,
Patients with peripheral neuropathy |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain scores at rest and movement will be aseessed eighth hourly till the time of discharge |
Postoperative pain scores at rest and movement will be aseessed eighth hourly till the time of discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional recovery,
Requirement of rescue analgesia,
Time for initiation of ambulation,
Length of hospital stay |
Immediate postoperative peroid, eighth hourly till the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/05/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Early mobilization following hip surgeries is thought to be an imperative part of postoperative management and has been associated with a reduction in postoperative complications such as thromboembolism, pneumonia, wound breakdown, pressure ulcers and delirium. Postoperatve analgesia plays an important role in early mobilization and initiation of physiotherapy. Analgesic techniques should aim to provide optimal pain relief while minimizing postoperative nausea, vomiting, hypotension and motor blockade. Peripheral nerve blocks are the choice of postoperative analgesia for hip surgeries as they facilitate effective joint mobilization, while limiting reflex muscle spasm and avoiding the side effects of continuous epidural analgesia(hypotension, urinary retention) and PCA morphine (postoperative nausea, vomiting, sedation). Continuous psoas compartment blockade posterior approach has been shown to provide good postoperative analgesia with postoperative pain scores. This is recently described technique, whereas epidural analgesia has been the standard of care at our institution for postoperative analgesia following total hip arthroplasty. We therefore aim to compare the efficacy of ultrasound guided continuous psoas subfascial blockade to continuous lumbar epidural blockade for postoperative analgesia in total hip replacement surgeries. Patients undergoing unilateral and bilateral total hip arthroplasty will be randomized into group P and Group E. The intraoperative guidelines for both groups will be standardized. Psoas subfascial block will be performed, either pre or postoperatively in a designated block area, a catheter placed under ultrasound guidance and secured. Administration of intermittent boluses of analgesics and assessment of postoperative pain scores will be carried out by the pain team. In group E, prior to the induction of anaesthesia epidural catheter will be placed and postoperative pain will be managed by continuous infusion of the drug as per the current protocol. In both the groups the patients will be assessed for pain scores at rest and on ambulation till the time of discharge. Functional recovery will also be compared between the two groups with modified harris hip score. |