| CTRI Number |
CTRI/2023/08/056620 [Registered on: 18/08/2023] Trial Registered Prospectively |
| Last Modified On: |
17/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To compare the effectiveness of pectoral nerve block and erector spinae nerve plane block in improvement of pain scores after breast cancer surgery. |
|
Scientific Title of Study
|
Comparison of ultrasound guided pectoral nerve block and erector spinae plane block in carcinoma breast patients undergoing modified radical mastectomy |
| 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 Ruchi Gupta |
| Designation |
Professor and Head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia,
Amritsar
PUNJAB
143001
India |
| Phone |
9814020805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tamanna Madaan |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia,
Amritsar
PUNJAB
143001
India |
| Phone |
9478784455 |
| Fax |
|
| Email |
tamanna.madaan94@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gagnjot Kaur |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia
Amritsar
PUNJAB
143001
India |
| Phone |
8198014504 |
| Fax |
|
| Email |
drgaganjot@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das Institute of Medical Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Mehta Road, Vallah, Amritsar |
| 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 Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Main Operation Theatre
Amritsar
PUNJAB |
9810420805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
Sham Block |
sham procedure will be performed on the side of surgery with the patient in supine position and the arm abducted. The ultrasound probe will be placed similarly as for PEC and ESP over the infraclavicular region and moved laterally. 1 ml of 2% lignocaine will be given for skin infiltration. |
| Intervention |
Ultrasound guided ESPN Block |
erector spinae plane block will be given with a high-frequency linear probe placed in a transverse orientation to visualize the right lateral tip of T4 transverse process. After identifying the three muscles trapezius, rhomboid major, and erector spinae superficial to the hyperechoic transverse process, the probe will be turned 90o longitudinally. After infiltrating 1 ml of 2% lignocaine, the block needle will be inserted in a cephalo-caudad direction to contact the transverse process. 30 ml of 0.25% levobupivacaine will be injected. The correct placement will be indicated by linear fluid spread between the erector spinae muscle and the underlying transverse processes and intercostal muscles. |
| Intervention |
Ultrasound guided PEC block |
pectoral nerve block will be performed on the side of surgery with the patient in the supine position and the arm abducted. The infraclavicular
9
region will be scanned to locate the axillary artery and vein. The probe will be moved laterally until pectoralis minor and serratus anterior muscles are identified at the level of the third rib. We will be using 1 ml of 2% lignocaine for skin infiltration. The needle will be advanced in an oblique manner until we are able to visualise its tip between the pectoralis minor and serratus anterior muscle. 20 ml of 0.25 % levobupivacaine will be deposited in between the muscles. We will withdraw the needle till the tip lies between the pectoralis major and minor and inject 10 ml of 0.25 % levobupivacaine. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Scheduled for unilateral elective carcinoma breast surgeries. |
|
| ExclusionCriteria |
| Details |
1. Patients having skin infections at the needle puncture site.
2. Patients suffering from coagulopathies/bleeding disorders.
3. Patient with chest wall/spine deformities.
4. Patients with BMI>35kg/m2.
5. Patients with a past history of neuropathies.
6. Pregnant patients.
7. Patients hypersensitive to the drugs being used in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of pectoral nerve block, erector spinae plane block |
Till 24 hours of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) To study the efficacy of PEC block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score & the number of rescue analgesics. B) To study the efficacy of ESP block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and the number of rescue analgesics. C) To study the sham block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics. D) To compare the efficacy of PEC and ESP block in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics to sham block.
|
Till 24 hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
28/08/2023 |
| 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="0"
Months="9"
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
|
BACKGROUND- Cancer breast is one of the most common causes of morbidity and mortality in females. According to National Cancer Registry, it accounts for 25-32% of all female cancers in India. Thirty one percent of the breast surgeries performed are Modified Radical Mastectomy (MRM). It is commonly performed under general anaesthesia and has been often associated with postoperative pain, nausea and vomiting; thus, causing increased patient suffering. Postoperative pain after breast cancer surgery is extremely debilitating and has been shown to be associated with severe morbidity as well as delay in recovery time. To manage this problem usually paravertebral blocks or thoracic epidurals were used but they are associated with various complications such as pneumothorax, vascular puncture, nerve damage. With the advent of ultrasound, pectoral nerve blocks (PEC) and erector spinae plane blocks (ESP) are now being performed routinely. They are considered quite effective for postoperative pain relief. But the data available for comparison of the two is limited. So, we hereby intend to compare the two latest modalities, when used along with GA for breast surgeries, i.e. the PEC block and the ESP block. OBJECTIVE- To compare the efficacy of pectoral nerve block and erector spinae plane block in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics in carcinoma breast patients undergoing modified radical mastectomy under general anaesthesia. MATERIALS AND METHODS- In three groups of 36 each, randomly selected patient, either ultrasound guided PEC block with 30ml of 0.25% levobupivacaine or ESP block with 30 ml of 0.25% levobupivacaine will be given along with GA . These two techniques will be compared with sham procedure performed with GA. EXPECTED BENEFITS- Reduction in intra-operative anaesthesia requirement, stable hemodynamics, opioid sparing effect, reduced post-operative pain, reduction in requirement of opioid analgesia during post-operative period. |