| CTRI Number |
CTRI/2022/10/046523 [Registered on: 17/10/2022] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study long term benefits of Ultrasound guided Erector Spinae Plane block on pain after 3 to 6 months of breast surgery: A Randomized Controllrd Trial |
|
Scientific Title of Study
|
To study the long term benefits of Ultrasound guided Erector Spinae Plane block on Post Mastectomy Pain Syndrome in patients undergoing breast surgery: A Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
POONAM GODHWAL |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
South
DELHI
110608
India |
| Phone |
09968646162 |
| Fax |
|
| Email |
godhwalpoonam@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
NISHKARSH GUPTA |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
South
DELHI
110608
India |
| Phone |
09013310014 |
| Fax |
|
| Email |
drnishkarshgupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
POONAM GODHWAL |
| Designation |
Senior Resident |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
Department of oncoanaesthesia and palliative medicine, IRCH, AIIMS, New Delhi
South
DELHI
110608
India |
| Phone |
09968646162 |
| Fax |
|
| Email |
godhwalpoonam@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
AIIMS, Ansari Nagar, New Delhi 110608 |
| 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 |
| Poonam Godhwal |
AIIMS, New Delhi |
Department of Oncoanaesthesia and Palliative Medicine, IRCH, AIIMS, New Delhi
South
DELHI |
9968646162
godhwalpoonam@yahoo.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
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 |
| Comparator Agent |
control group |
no intervention will be done in this group |
| Intervention |
Ultrasound guided Erector Spinae Plane block |
• ESP block will be performed in the operative room following standardized monitoring, including noninvasive blood pressure, electrocardiogram, and pulse-oximetry. All blocks will be performed approximately 20 min before induction of general anaesthesia by the anaesthesiologist with experience in ultra sound (US) guided nerve blocks. Patients will be placed in sitting position and spine will be palpated from C7 downward to T5 and point will be marked to identify the spinous process. Ultrasound machine (Fujifilm Sonosite M-Turbo) with high frequency linear probe (5-13MHz) will be used for block performance using 22G x 50mm echogenic block needle (SonoTAP). The block will be performed unilaterally (on the side of surgery) after skin preparation using 10% povidone iodine, using linear probe with a sterile cover. The linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. The three muscles from outward will be recognized trapezius, rhomboideus major, and erector spinae muscle. Once the erector spinae muscle and the transverse process is identified, the needle will be inserted in-plane to the ultrasound beam in a cranial- caudal direction until contact is made with the T5 transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5ml of local anaesthetic (LA), 20 ml of 0.25% ropivacaine will be administered for block performance after negative aspiration. LA distribution will be performed in both cranial and caudal direction. The patients will be observed for 20 min after block performance. The sensory level of block will be assessed by anaesthesiologist with pin-prick sensation every 5 min in each dermatomal distribution from T1 to T8. The total number of dermatomes that has less pain to pin prick compared with opposite side will be noted. If the pin-prick sensation does not decrease in any segment up to 15 min, it will be considered as a block failure and patient should be excluded from study. The patients ECG and SpO2 will be monitored continuously, and heart rate (HR) and NIBP will be recorded at baseline, after performing the block, and every 5 min for 15 min. Any block-related complications, such as hypotension or vascular puncture, will be recorded. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 20-65 years
American Society of Anesthesiologists (ASA) physical status I-II
Scheduled for elective surgery for breast cancer (unilateral surgical procedure).
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection of the skin at the site of the needle puncture
3. Chronic infection
4. Known allergies to any of the study drugs
5. Coagulopathy
6. Patient already receiving analgesics
7. Mentally challenged patients
8. Liver and renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire |
• To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i. 24 hours postoperative consumption of opioids
ii. Intraoperative and postoperative hemodynamic changes
iii. Postoperative pain assessment up to 24 hours using Numeric Pain Rating Scale score (NRS) and duration of analgesia in 24 hours
iv. Incidence of nausea, vomiting, degree of sedation and any complication up to 24 hrs postoperatively
v. Neutrophil-Lymphocyte ratio (NLR), Platelet lymphocyte ratio (PLR), Number of T Helper Cells, Natural Killer Cells (NKC) and Cytotoxic T Cells at baseline and after 24 hours of surgery
vi. Effect on expression of monoclonal antibodies in leukocyte subsets CD45, CD3, CD4, CD8, CD19, CD16, CD56 for follow up of cancer recurrence. For this, patients will be recruited for 12 months and follow up will be done over next 6 months.
|
a. 6 months follow up for post mastectomy pain syndrome
b. intraoperative and postoperative for 24 hours for opioid consumption, hemodynamics, pain assessment
c. patient recruitment for 12 months and follow up over next 6 months for cancer recurrence |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
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)
|
20/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication details will be mention after the trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The peri-operative pain management appeared as major point to reduce the risk of chronic pain after surgery. A potential target for an interventional procedure for chronic pain after treatment for breast cancer is the Erector Spinae Plane (ESP) block. Here, local anaesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerve dermatomes from vertebral C5 to T6. Local anaesthetic expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally. This block can be given unilaterally for breast surgeries with anaesthesia similar to that of thoracic epidural block without its hemodynamic side effects. In this study we will compare ESP block with control for prevention of post mastectomy pain syndrome. |