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CTRI Number  CTRI/2024/03/064754 [Registered on: 26/03/2024] Trial Registered Prospectively
Last Modified On: 22/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of quality of pain relief provided by two block techniques given with ultrasound in the chest wall; namely Pecto-Intercostal Fascial Plane block and Serratus Anterior Plane block for managing pain after cardiac surgeries performed with incision through the breastbone.  
Scientific Title of Study   Comparison Of Ultrasound-guided Pecto-Intercostal Fascial Plane block and Serratus Anterior Plane block in managing post-sternotomy pain after cardiac surgery: A Randomised Controlled 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 Kaushal Kenchey 
Designation  Fellow, Cardiac Anaesthesia 
Affiliation  Bharati Vidyapeeth (Deemed to be) University Medical College 
Address  Department of Anaesthesia, 3rd floor, MOT complex, Bharati Vidyapeeth (Deemed to be) University Medical college, Pune-Satara Road, Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9032113377  
Fax    
Email  kaushalkenchey.kk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalyani Nilesh Patil 
Designation  Professor, Department Of Anaesthesia 
Affiliation  Bharati Vidyapeeth (Deemed to be) University Medical College 
Address  Department of Anaesthesia, 3rd floor, MOT complex, Bharati Vidyapeeth (Deemed to be) University Medical college, Pune-Satara Road, Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9673400066  
Fax    
Email  kalyanish19@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalyani Nilesh Patil 
Designation  Professor, Department Of Anaesthesia 
Affiliation  Bharati Vidyapeeth (Deemed to be) University Medical College 
Address  Department of Anaesthesia, 3rd floor, MOT complex, Bharati Vidyapeeth (Deemed to be) University Medical college, Pune-Satara Road, Dhankawadi

Pune
MAHARASHTRA
411043
India 
Phone  9673400066  
Fax    
Email  kalyanish19@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Bharati Vidyapeeth (Deemed to be) University Medical College, Pune 
 
Primary Sponsor  
Name  Bharati Vidyapeeth (Deemed to be) University Medical College, Pune 
Address  Bharati Vidyapeeth Campus, Pune-Satara road, Dhankawadi, Pune 411043. 
Type of Sponsor  Private 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 kalyani Nilesh Patil  Bharati Hospital, Pune  Department of Anaesthesia, 3rd floor, Major Operation Theatre Complex
Pune
MAHARASHTRA 
9673400066

kalyanish19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth (Deemed to be) University Medical College, Institute Ethics Committee  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 
Intervention  Ultrasound guided Pecto-intercostal fascial plane block  Bilateral Pecto-intercostal fascial plane block will be given under Ultrasound guidance, after completion of elective cardiac surgery with median sternotomy incision. The efficacy of postoperative analgesia will be assessed till 24 hours post-extubation. 
Comparator Agent  Ultrasound guided Serratus Anterior plane block  Bilateral Serratus Anterior plane block will be given under Ultrasound guidance, after completion of elective cardiac surgery with median sternotomy incision. The efficacy of postoperative analgesia will be assessed till 24 hours post-extubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status III, in the age group of 18-60 years, posted for elective cardiac surgeries with midline sternotomy, under general anaesthesia. 
 
ExclusionCriteria 
Details  Patients with delayed extubation (more than 6 hours postoperatively)
Patients with altered mental status or psychiatric illness
patients with infection or trauma at the site of block 
 
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 the efficacy of postoperative analgesia with Pecto-intercostal fascial plane block and Serratus Anterior Plane block.  Postextubation time to request of analgesic or VAS (Visual Analog Scale) more than 3, will be assessed at extubation and post-extubation at 2hours, 4 hours, 6 hours, 8 hours, 12 hours, 16 hours, 20 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare performance of Incentive spirometry.  Immediately after extubation, at 6 hours & 12 hours after extubation 
Total analgesic requirement in first 24 hours post-extubation  First 24 hours from extubation. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 
Date of First Enrollment (India)   01/04/2024 
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="0"
Months="3"
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
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. 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

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data not yet available

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Postoperative pain following sternotomy is a common occurrence in cardiac surgery, often attributed to factors like rib fractures, or intercostal nerves resulting from prolonged sternal retraction and surgical incisions. Although the intensity of acute post-sternotomy pain peaks on the first day after surgery, it can persist upto a week. In cardiothoracic surgery, regional anaesthesia is frequently integrated into multimodal analgesic strategies to mitigate acute post sternotomy pain. This approach, especially in the context of Enhanced Recovery has gained popularity for its potential to reduce opioid usage and associated side effects. Pain generated from a sternotomy incision is complex and has been attributed to various pain-generators. The quest for an ideal analgesia technique continues despite various advances in multimodal analgesia. In this study we aim to compare a novel technique of Pecto-Intercostal Fascial Plane (PIFP)  block with the well-established Serratus Anterior Plane (SAP) block. Pecto-intercostal fascial plane block is a superficial block as compared to serratus anterior plane block and can be performed in the supine position.

AIM:

 

To compare the efficacy of ultrasound guided bilateral Pecto-intercostal fascial plane (PIFP) block and Serratus anterior plane (SAP) block in managing acute post sternotomy pain in patients undergoing elective cardiac surgery with midline sternotomy.

 

OBJECTIVES: 

 

Primary:

      To compare the efficacy of postoperative analgesia with  PIFP and SAP.

 

Secondary:

       To compare PIFP & SAP with respect to:

                       Performance of incentive spirometry

                       Total analgesic requirement in first 24 hours post-extubation.

1. During the pre-anaesthesia visit, informed, valid consent will be taken from the study population, in the language best understood by them and after explaining them the study in detail. They will be also explained the visual analogue scale that will be used for assessment of postoperative analgesia.

2. Patients will be randomly allocated to one of the two groups based on a 1:1 randomization ratio (Group A or Group B) using opaque sealed envelopes one hour before surgery. Randomization will be performed using a computer-generated random number list (Microsoft Office 365 Excel, Microsoft, Redmond, WA).

3.  Each patient will be asked to choose an envelope containing the name of a group, which is numbered according to randomization, to which the patients subsequently were assigned.

4.  All patients, outcome assessors (anesthesia residents and nursing staff), and surgeons will be blinded to the group assignments. An anaesthesiologist with expertise in regional anesthesia will perform the blocks to ensure the quality and consistency.

5. The PIFP and SAP blocks will be administered after completion of cardiac surgery before final dressing of suture wound. The standard monitoring of ECG, oxygen saturation and intra-arterial blood pressure will be continued till the completion of the block.

6. PIFP and SAP block will be performed under all aseptic precautions and under ultrasound guidance using the high-frequency linear ultrasound probe (13-6 MHz).

7.    After successful and satisfactory administration of either of the blocks, the patient will be shifted to cardiac recovery ICU. The time of block completion will be noted.

8.    All patients will receive Inj Paracetamol 1gm i.v. 8 hourly.  

9.    The time to extubation will be defined as the time elapsed from the completion of block to the time of extubation of the trachea.

10.The postoperative pain will be assessed using the visual analogue scale (VAS)  at extubation, every 2 hours thereafter for first 8 hours post-extubation, and every 4 hourly thereafter till 24 hours post-extubation. 

11.If VAS >3, patients will be administered Inj. Fentanyl 0.5-1 mcg/kg intravenously as rescue analgesic.

12.The duration of postoperative analgesia will be defined as the duration from the completion of the block to the first dose of rescue analgesic administered to the patient.

13.The total analgesic consumption over 24 hours postextubation will be compared in both the groups. 

14.VAS will be assessed during incentive spirometry. 

15.The performance of incentive spirometry will be assessed and compared in both groups (no of balls lifted during incentive spirometry).

 
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