| CTRI Number |
CTRI/2024/08/071945 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare pain relieving effect of intrathecal morphine and adductor canal block in patients undergoing knee ligament repair surgery |
|
Scientific Title of Study
|
Comparison of intrathecal morphine and adductor canal block for analgesic efficacy in patients undergoing knee arthroplasty-a randomized controlled 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.Jaipriya Desigan |
| Designation |
Academic junior resident 1st year |
| Affiliation |
Aiims,Kalyani |
| Address |
Department of Anaesthesiology,Aiims, Kalyani,Basantpur,Nadia District,West Bengal
Nadia
WEST BENGAL
741250
India |
| Phone |
6379435903 |
| Fax |
|
| Email |
jaipriya.anaesth_pgt24@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Sekar L |
| Designation |
Assisstant Professor |
| Affiliation |
Aiims,Kalyani |
| Address |
Department of Anathesiology, Aiims Kalyani,Basantpur,Nadia District,West Bengal
Nadia
WEST BENGAL
741250
India |
| Phone |
8146555023 |
| Fax |
|
| Email |
sekar.anesth@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Anjum Naz |
| Designation |
Head of department |
| Affiliation |
Aiims,Kalyani |
| Address |
Department of Anaesthesiology,Aiims Kalyani,Basantpur,Nadia District,West Bengal
WEST BENGAL
741250
India |
| Phone |
9836893073 |
| Fax |
|
| Email |
anjum.anesth@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| Aiims Kalyani,Basantpur,Nadia District,West Bengal-741250 |
|
|
Primary Sponsor
|
| Name |
Aiims Kalyani |
| Address |
Aiims Kalyani,Basantpur,Nadia district,West Bengal-741250 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jaipriya Desigan |
Aiims,Kalyani |
Department of Anaesthesiology, Aiims Kalyani,Basantpur,Nadia District,West Bengal-741250
Nadia
WEST BENGAL |
6379435903
jaipriya.anaesth_pgt24@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,AIIMS,KALYANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adductor canal block |
with injection bupivacaine 0.25%
over the medial aspect of mid-thigh |
| Intervention |
Intrathecal morphine |
100mcg of intrathecal morphine along with subarachnoid puncture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of Age 18-65 years of both sexes with American Society of Anesthesiologist (ASA) 1 and 2 undergoing knee arthroplasty under spinal anesthesia
|
|
| ExclusionCriteria |
| Details |
total surgical duration more than 3 hours
ASA 3 and 4
refuse to consent for spinal anesthesia
history of coagulopathy with raised INR more than or equal to 1.5
local infection at needle insertion site
history of psychiatric illness and on antipsychotic medications
history of opioid dependence
history of chronic pain
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cumulative morphine equivalent consumption
|
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Numeric Rating scale for pain
2. Time to first postop mobilisation
3. Quadriceps muscle strength
4. Adverse effects (Nausea, Vomitting, pruritus)
|
1.Numeric Rating scale for pain at 0,2,4,6,8,12 & 24 hours
2. Time to first postop mobilisation
3. Quadriceps muscle strength at 6,8,12 & 24 hours
4. Adverse effects (Nausea, Vomitting, pruritus)
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/08/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we compare intrathecal morphine and adductor canal block for analgesic efficacy in patients undergoing knee arthroplasty by measuring 24 hours cumulative morphine equivalent consumption and also by measuring postoperative pain score by numerical rating scale
|