| CTRI Number |
CTRI/2024/02/063317 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effectiveness of drug given under direct vision and under ultrasound to blunt the pain after breast removal surgery |
|
Scientific Title of Study
|
A comparative study to evaluate analgesic efficacy of pre operative and intraoperative pectoralis nerve block for patients undergoing Modified Radical Mastectomy |
| Trial Acronym |
PEC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Famna Faisal C H |
| Designation |
Junior Resident Doctor |
| Affiliation |
Guru Gobind Singh Medical College Faridkot |
| Address |
Dept of Anaesthesia
Guru Gobind Singh Medical College Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9995097002 |
| Fax |
|
| Email |
fffamna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College Faridkot |
| Address |
Dept of Anaesthesia
GGSMCH, Faridkot
Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Haramritpal Kaur |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College Faridkot |
| Address |
Dept of Anaesthesia
GGSMCH, Faridkot
Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9878088013 |
| Fax |
|
| Email |
amritk_dr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Guru Gobind Singh Medical College Faridkot |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Guru Gobind Singh Medical College Faridkot |
| 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 Famna Faisal CH |
Guru Gobind Singh Medical College Faridkot |
Department of Anaesthesia
Guru Gobind Singh Medical College
Faridkot
Faridkot
PUNJAB |
9995097002
fffamna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Gobind Singh Medical College Faridkot |
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 |
| Intervention |
A comparative study to evaluate analgesic efficacy of pre operative and intraoperative pectoralis nerve block for patients undergoing Modified Radical Mastectomy |
To evaluate the effect of pre operative USG guided pectoral nerve block with 30ml 0.25% ropivacaine for pain relief for patients undergoing MRM.
To evaluate the effect of Intra-Operative under vision pectoral nerve block with 30ml 0.25% ropivacaine for pain relief for patients undergoing MRM.
To compare pre operative USG guided and intraoperative under vision pectoral nerve block with 30ml 0.25% ropivacaine for pain relief for patients undergoing MRM.
|
| Comparator Agent |
Ultrasound guided and Under vision pec 1 and 2 block |
Injection Ropivacaine 0.25%
Ultrasound sound guided technique done prior to surgery after induction and undervision pec block given by surgeon after radical dissection, the post op analgesic duration measured till 24 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients undergoing unilateral modified radical mastectomy under general anesthesia.
Age group between 18 to 65 years of either gender, giving valid informed and written consent.
American Society of Anaesthesiologist grade I and II
|
|
| ExclusionCriteria |
| Details |
Patients with any contraindication to regional anesthesia.
Patients with a history of anaphylaxis to local anaesthetics and allergy to the study drugs.
Pregnant or lactating patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of pre operative USG guided and intra operative pectoral nerve block with 30ml 0.25% ropivacaine each for pain relief for patients undergoing MRM.e pre operative USG guided and intraoperative under vision pectoral nerve block.
Analgesic efficacy evaluated with VAS score and the duration until first rescue analgesic given. |
Outcome will be assessed at the end of study of 1.5 yrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The need for rescue analgesic after the USG guided & undervision pec block |
Outcome will be assessed with in 24 hours of pec block |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/03/2024 |
| 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="6"
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 - NO
|
|
Brief Summary
|
Post operative pain associated with modified radical mastectomy in breast cancer surgery is a growing concern. Various modalities for regional anaesthesia have been studied and practiced for the same. One such latest method is pectoralis nerve block, which is found to be efficient and effective. The aim and objective is to evaluate the analgesic efficacy of pre operative ultrasound (USG) guided pectoralis nerve block and intra operative pectoralis nerve block in modified Radical mastectomy (MRM) under General anaesthesia (GA). |