| CTRI Number |
CTRI/2024/01/061291 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
03/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of USG-Guided pain management approaches for incision through breast bone in cardiac surgeries by injecting local anaesthetic drug between Transverse Thoracic Muscle Plane versus Pecto-Intercostal Fascial. |
|
Scientific Title of Study
|
A comparative analysis of USG-Guided pain management approaches for sternotomy in cardiac surgeries: Transverse Thoracic Muscle Plane Block versus Pecto-Intercostal Fascial Block |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hemant Vanjare |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
5th floor OT complex
Sri Aurobindo Medical college,
Indore
Indore MADHYA PRADESH 453555 India |
| Phone |
08109788337 |
| Fax |
|
| Email |
drhemantvanjare@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Hemant Vanjare |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
5th floor OT complex
Sri Aurobindo Medical college,
Indore
MADHYA PRADESH 453555 India |
| Phone |
08109788337 |
| Fax |
|
| Email |
drhemantvanjare@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Hemant Vanjare |
| Designation |
Assistant Professor |
| Affiliation |
Sri Aurobindo Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
5th floor OT complex
Sri Aurobindo Medical college,
Indore
MADHYA PRADESH 453555 India |
| Phone |
08109788337 |
| Fax |
|
| Email |
drhemantvanjare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Aurbindo Institute of Medical Sciences, Indore, (M.P.) |
|
|
Primary Sponsor
|
| Name |
Sri Aurobindo Institute of Medical Sciences |
| Address |
Indore-Ujjain State Highway, Near MR-10 Crossing Sanwer road Indore |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DrHemant Vanjare |
Sri Aurobindo Institute of Medical Sciences, |
Department of Anaesthesiology,
5th Floor OT Complex,
Hospital Building Indore MADHYA PRADESH |
08109788337
drhemantvanjare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Aurobindo Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pecto-Intercostal Fascial Block (PIF) |
Group PIF, Single shot, 20ml of 0.25% ropivacaine will be injected in pecto-intercostal plane under ultrasound guidance |
| Comparator Agent |
Transverse Thoracic Muscle Plane Block (TTP) |
In group TTP, Single shot, 20ml of 0.25% ropivacaine will be injected bilaterally under ultrasound guidance in tranverse thoracic plane |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing major cardiac surgery.
Age 18-70y |
|
| ExclusionCriteria |
| Details |
Patients not extubated in first 24hr
Emergency surgery
Patient with psychiatric illness and opioid dependant patient. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find Opioid consumption |
in first 24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To access Pain score in numeric rating scale(NRS) |
In first 24 hours after sternotomy in cardiac surgery. |
|
|
Target Sample Size
|
Total Sample Size="59" Sample Size from India="59"
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)
|
15/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/01/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" 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
|
Aims-To study and compare effect of USG guided transverse thoracic muscle plane block with pecto-intercostal fascial block for post-sternotomy pain in cardiac surgery. OBJECTIVES-: ï‚· To find Opioid consumption in first 24 hours after sternotomy in cardiac surgery. ï‚· To access Pain score in numeric rating scale(NRS) in 12 hr. and 24 hr.
Introduction
Pain management has a critical role in providing an earlier return to normal activities.1 Currently, opioid-based analgesia strategies have the main role after cardiac surgery, but respiratory depression nausea, vomiting, itching, urinary retention, and risk of opioid addiction are well-known undesirable effects. Pain can cause pulmonary complications such as insufficient clearance of secretions, prolonged weaning, acute respiratory failure as a result of shallow breathing, and ineffective coughing. Effective control of pain is essential for the reduction of all these complications, including postoperative mortality and morbidity.2,3 Cardiac surgery is mostly done via open midline sternotomy. The bone cutting incision is major cause of morbidity. Most sternotomy pain occurs because of tissue injury in the skin, subcutaneous tissues, bone, and cartilage. Intercostal nerves arising from thoracic nerve roots innervate the sternum, ribs, and surrounding subcutaneous tissue. The principal thoracic nerves supplying the sternum are T2 to T6 4,5 The effectiveness of thoracic epidural and paravertebral blocks have been demonstrated following cardiac surgeries. However, many anesthesiologists are reluctant to utilize these blocks due to the possibility of developing a spinal hematoma from heparinization and hemodilution.6 In recent years, the popularity of fascial plane blocks accompanied by ultrasound has increased in the management of postoperative analgesia. With ultrasound increasing anatomic control, it encourages anesthesiologists to use regional anesthesia. Fascial plane8 blocks, in which the risk of bleeding is low compared with central neuraxial techniques or deep nerve blocks, are increasingly becoming a part of multimodal analgesia as an alternative pain management strategy in cardiac surgery. Parasternal blocks,7 erector spinae plane (ESP) blocks,8 and pectoralis nerve blocks9 have been successfully used to alleviate sternotomy pain after cardiac surgery. Transversus thoracic muscle plane block (TTMPB) was first described by Ueshima et al.10 in 2015. They showed in a cadaver study that the local anesthetic placed between the intercostal muscles and the transverse thoracic muscle covers T2-T6 intercostal nerves.11 Data other than a pilot study evaluating the effect of the TTMPB on sternotomy pain12 are in the form of case reports. To the authors’ knowledge, this study is the first randomized, controlled, double-blind study about the effectiveness of TTMPB in cardiac surgery. The PIFB consists in injecting local anesthetics close to the sternum in the plane between the pectoralis major and internal intercostal muscle TTMPB and PIFB have similar effectiveness in acute post-sternotomy pain treatment. Since PIFB is easy to apply and has a low rate of serious complications. PIFB may be a more attractive option for acute post-sternotomy pain management. The current study was designed based on the hypothesis that the perioperative analgesic effectiveness of TTPB and PIFB in children undergoing cardiac surgery via median sternotomy is comparable.
SOURCE OF DATA - This study will be carried out at the Department of Anaesthesiology and Critical Care, Sri Aurobindo Institute Of Medical Sciences Hospital, Indore (M.P).
SELECTION OF CASES- After Ethical committee clearance, a total of 59 patients age 18-70years scheduled for elective cardiac surgeries will be selected randomly. An informed written consent will be taken from all the patients relatives in groups after the approval of institutional ethical committee and as per inclusion and exclusion criteria
METHOD OF COLLECTION OF DATA – •118 Patients posted for elective cardiac surgery will be selected for the study. All patients will undergo thorough pre-anaesthetic evaluation before surgery. •Routine investigations will be done. •Written informed consent will be obtained. •Patients will be advised Nil Orally for a period of 6-8 hours prior to surgery.
After the clearance from ethical committee, Patients will be enrolled for the study and after informed consent after explaining the procedure and intervention specific to study will be taken. Patients will be divided into two groups: 1. GROUP TTP – Transverse Thoracic Muscle Plane Block 2. GROUP PIF – Pecto-Intercostal Fascial Block In group TTP 20ml of 0.25% ropivacaine will be injected bilaterally under ultrasound guidance in tranverse thoracic plane while in group PIF, 20ml of 0.25% ropivacaine will be injected in pecto-intercostal plane under ultrasound guidance . In post operative protocol time of extubation will be looked for.
Statistical Analysis Plan The data will be collected and entered in MS excel 2010. Data will be analyzed from R software and will be presented in frequency table. Descriptive statistics will be calculated as mean & SD for quantitative variable and frequency and percentage for qualitative or categorical variables. Pie or bar diagram will be used for Qualitative or demographical variables. Independent t test/Mann Whitney U test will be applied for compare between two quantitative groups. Repeated measured ANOVA test/Friedman test will be applied for more than 2 time follow up and post hoc test will be applied for multiple pre and post comparisons If p value <0.05, considered as statistically significant result and if p-value>0.05, then it is statistically insignificant result |