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CTRI Number  CTRI/2024/10/075355 [Registered on: 16/10/2024] Trial Registered Prospectively
Last Modified On: 25/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of pain relieving effect of ultrasound guided lateral (modified) erector spinae plane block with erector spinae plane block in patient undergoingModified breast surgery 
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound-guided lateral erector spinae plane block versus erector spinae plane block in patient undergoing Modified Radical Mastectomy: A randomised control trial 
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 Shagufta Naaz 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  501, Block A, 5th Floor, IPD Building, Department of Anaesthesiology, AIIMS Patna, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shagufta Naaz 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  501, Block A, 5th Floor, IPD Building, Department of Anaesthesiology, AIIMS Patna, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shagufta Naaz 
Designation  Additional Professor 
Affiliation  All India Institute of medical Sciences, Patna 
Address  501, Block A, 5th Floor, IPD Building, Department of Anaesthesiology, AIIMS Patna, Phulwarisharif, Patna

Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Patna, Phulwarisharif, Patna, Bihar, India. Pin code 801507 
 
Primary Sponsor  
Name  AIIMS Patna 
Address  AIIMS Patna, Phulwarisharif, Patna. 801507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shagufta Naaz  All India institute of Medical Sciences, Patna  Room no.501, 5th Floor, A Block, IPD Building, All India Institute of Medical Sciences, Patna, Phulwarisharif, Patna
Patna
BIHAR 		 7765937919

drshaguftanaaz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-AIIMS-P  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector Spinae Plane block  After GA, a 21-gauge, 8 cm insulated echogenic needle will be inserted under real-time in-plane between the erector spinae and 5th vertebra transverse process on the side to be blocked, single injection of 20 ml 0.25% bupivacaine will be administered. 
Intervention  USG guided lateral erector spinae plane block  After GA, a 21-gauge, 8 cm insulated echogenic needle will be inserted under real-time in-plane between the erector spinae and 5th rib just lateral to the transverse process on the side to be blocked, single injection of 20 ml 0.25% bupivacaine will be administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. ASA I and II
2. Patients between the ages of 18-70 years
3. Duration of surgery less than 3 hrs
4. Female
5. BMI 18-30kg/m2 
 
ExclusionCriteria 
Details  History of severe liver, renal or cardiovascular disease or chronic pain disease
2. Pre-existing neurological or psychiatric illness
3. Any bleeding abnormality
4. Diagnosis of allergy to the study drug
5. History of alcohol or drug abuse
6. History of chronic use of analgesics, sedatives, opioids, or steroids
7. Pregnancy
8. Uncooperative (due to dementia, mental retardation, etc.)
9. Procedure site infection
10. History of previous mastectomy 11. Severe spine/chest wall deformity 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare postoperative opioid consumption  24 h postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Time to first rescue analgesia
2. Total intraoperative opioid consumption
3. Numerical rating score of pain in first 24 hours post operatively
4. PONV 		 1. After surgery
2. Till the end of surgery
3. At 1st, 2nd,
6th, 12th, 24th hour
4. Till 24 hour postoperatively 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 
Date of First Enrollment (India)   25/10/2024 
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 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  

For a long time, various regional anesthesia techniques including thoracic paravertebral block, Erector spinae plane block, Pecs block etc. has been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect.The Erector spinae plane block (ESPB) is an interfascial regional anaesthesia technique where local anaesthetic is infiltrated into an interfacial space between erector spinae muscles and transverse process on the posterior chest wall at the level T5. Lateral ESPB is a novel approach for ESPB where local anaesthetic is infiltrated into an interfacial space slight laterally on the rib. Just two case series have been done which has shown that this approach is efficacious in providing analgesia. In lateral ESP block, local anaesthetic is infiltrated into an interfacial space between erector spinae and intercostal muscle on posterior chest wall at the level T5. It has been also found to provide good analgesia. There is no RCT comparing these two blocks.

Novelty– This study is one of its kind where USG guided lateral ESP blocks will be performed in MRM and will be compared to the group where conventional ESP block will be performed in terms of analgesic efficacy

Aim (One sentence) – To compare the analgesic efficacy of lateral erector spinae plane block with conventional erector spinae plane block in patient undergoing MRM/abdominal surgery.

Primary Objective- To compare postoperative opioid consumption. 

Secondary Objective (Optional)

  1. Time to first rescue analgesia

  2. Total intraoperative opioid consumption

  3. Numerical rating score of pain in first 24 hours post operatively : at 1st, 2nd,

    6th, 12th, 24th hour

  4. PONV Methodology:

    A. Study design: A randomized controlled and double-blind study 

    B. Study participants– Female with breast cancer undergoing Unilateral MRM with or without axillary dissection under GA at AIIMS Patna

    i. Inclusion criteria -

    ASA I and II
    Patients between the ages of 18-70 years 

    BMI <= 35 kg/m2

    b. Sample size calculation: Alpha: 5% Confidence interval (2 – sided): 95% Beta :20%, Ratio of sample size (Group LESPB/Group EPSB): 1:1, Total 88 (44 in each group)

    ii. Exclusion criteria –

    1. History of severe liver, renal or cardiovascular disease or chronic pain disease

    2. Pre-existing neurological or psychiatric illness

    3. Any bleeding abnormality

    4. Diagnosis of allergy to the study drug

    5. History of alcohol or drug abuse

    6. History of chronic use of analgesics, sedatives, opioids, or steroids

    7. Procedure site infection

    8. History of previous mastectomy 9. Severe spine/chest wall deformity 

Group Lateral Erector Spinae 20 ml of 0.25% bupivacaine deposited between erector spinae and 5th rib just lateral to the transverse process of the side to be operated

Group Erector Spinae 20 ml of 0.25% bupivacaine deposited between erector spinae and 5th transverse process of the side to be operated

Appropriate statistical analysis will be done

Expected outcome: Administration of lateral ESP is expected to provide same analgesic efficacy as conventional ESP in the early perioperative period. 

 
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