| CTRI Number |
CTRI/2024/07/070669 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Erector Spinae Plane block with Intrathecal Morphine for post-operative pain relief in patients undergoing surgery for gynaecological malignancies. |
|
Scientific Title of Study
|
Comparison of Erector Spinae Plane block with Intrathecal Morphine for post-operative analgesia in patients undergoing surgery for gynaecological malignancies. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aarushi Aggarwal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 413,BL Taneja Block,Department Of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002.
Central
DELHI
110002
India |
| Phone |
8178143807 |
| Fax |
|
| Email |
arushi.1696@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahil Singh |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 413,BL Taneja Block,Department Of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002.
Central
DELHI
110002
India |
| Phone |
981071902 |
| Fax |
|
| Email |
drrahilsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aarushi Aggarwal |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room No. 413,BL Taneja Block,Department Of Anaesthesiology,Maulana Azad Medical College,New Delhi,110002.
Central
DELHI
110002
India |
| Phone |
8178143807 |
| Fax |
|
| Email |
arushi.1696@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital,Jawaharlal Nehru Marg,near Delhi Gate,New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College,2,Bahadur Shah Zafar Marg,New Delhi,110002 |
| 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 Aarushi Aggarwal |
Lok Nayak Hospital |
Gynae OT,1st floor,Obstetrics and Gynaecological Block,Department of Anaesthesiology
Central
DELHI |
8178143807
arushi.1696@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Plane Block |
erector spinae plane block with 20 ml of 0.25% bupivacaine each injected bilaterally at L2-L3 level in the pre-induction period for post-operative analgesia in patients undergoing surgery for gynaecological malignancy. |
| Intervention |
Erector Spinae Plane Block with Intrathecal Morphine |
20 ml of 0.25% bupivacaine each injected bilaterally at L2-L3 level in erector spinae plane block in the pre-induction period compared with 200 mcg of morphine in 2ml of normal saline injected intrathecally at L3-L4 level in the pre-induction period for post-operative analgesia in patients undergoing surgery for gynaecological malignancies. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients of age 18-80 years
2. Patients fulfilling American Society of Anesthesiologists (ASA) physical status I, II, III criteria.
3. BMI: 18-35kg/m2 (body weight atleast 40 kg)
4. Surgical approach via midline abdominal incision. |
|
| ExclusionCriteria |
| Details |
1. Known allergy to the drugs in the study 2. Pregnancy 3. Any contraindication to a regional/neuraxial local anesthetic, such as bleeding disorders or local infection 4. History of chronic pain or patient on chronic pain medication 5. Drug abuse |
|
|
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 |
| Time to request for first rescue analgesia. |
24 hours in the post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Numerical Rating Scale at 2,4,6,12 and 24 hours postoperatively.
2. Total consumption of intravenous fentanyl intraoperatively.
3. Number of patients reporting any opioid related complications over 24 hours postoperatively (pruritis, nausea and vomiting) 4. Total consumption of rescue analgesic medication in 24 hours.
5. Sedation score at 2,4,6,12, and 24 hours postoperatively
6. Quality of recovery ( QoR-15 ) at 24 hours post operatively. 7. Patient satisfaction score at 24 hours postoperatively |
12 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arushi.1696@gmail.com].
- For how long will this data be available start date provided 13-07-2025 and end date provided 14-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
We are comparing Erector Spinae Plane Block with Intrathecal morphine for post-operative analgesia in patients of age group 18-80 yrs undergoing surgery for gynaecological malignancy.The aim of the study is to compare Erector Spinae Plane Block with Intrathecal morphine for post-operative analgesia in patients undergoing surgery for gynaecological malignancy, taking a total sample size of 38, 19 patients in each group. |