| CTRI Number |
CTRI/2021/08/035455 [Registered on: 05/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study comparing two pain relief methods(Transversus Thoracis Muscle plane block and Pecs block) for speeding up the recovery patients after operation on heart |
|
Scientific Title of Study
|
Randomized comparative study of effect of Pecs block and Transversus thoracis muscle plane block on ultra-fast tracking of patients undergoing cardiac surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rati Prabha |
| Designation |
Assistant Professor |
| Affiliation |
King Georges Medical University |
| Address |
Room Number 1, Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
7905912607 |
| Fax |
|
| Email |
ratiprabha83@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rati Prabha |
| Designation |
Assistant Professor |
| Affiliation |
King Georges Medical University |
| Address |
Room Number 1, Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
7905912607 |
| Fax |
|
| Email |
ratiprabha83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rati Prabha |
| Designation |
Assistant Professor |
| Affiliation |
King Georges Medical University |
| Address |
Room Number 1, Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow, Uttar Pradesh
Lucknow UTTAR PRADESH 226003 India |
| Phone |
7905912607 |
| Fax |
|
| Email |
ratiprabha83@gmail.com |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Chowk, Lucknow-226003, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Rati Prabha |
| Address |
Room no.1, Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow-226003, Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Rati Prabha |
King Georges Medical University |
Room No 1, Cardiac Surgical OT Complex, Department of Anesthesiology, King Georges Medical University, Chowk, Lucknow-226003, Uttar Pradesh Lucknow UTTAR PRADESH |
7905912607
ratiprabha83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King Georges Medical University, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pec block(for group P) |
Patients will be given bilateral ultrasound guided Pecs block using 0.25% ropivacaine and 25microgram dexmedetomidine after end of surgery(after skin closure). 10 ml drug solution will be given for Pec I block and 20 ml will be given for Pec II block on each side. |
| Comparator Agent |
Transversus thoracis
muscle plane block (for Group T) |
Patients will be given bilateral ultrasound guided transversus thoracis
muscle plane block using 0.25% ropivacaine and 25microgram dexmedetomidine after end of surgery(after skin closure). 20 ml of drug solution will be given on each side. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologists physical status III-IV, undergoing elective cardiac surgery undergoing median sternotomy for valve replacement/Coronary artery bypass graft/isolated ventricular or atrial septal defect will be recruited in the study. |
|
| ExclusionCriteria |
| Details |
Ejection Fraction less than 40%, Aortic cross clamp time more than 120 minutes, Re-do Cardiac surgery, Coagulopathy, Refusal to give consent, Surgery for both Coronary artery bypass graft and valvular repair at same time, Liver or renal disease |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia (defined as time gap between the time of giving nerve block and analgesic requested by the patient) |
post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pain intensity as measured by numeric rating scale |
Immediately after extubation, and at 3 hours, 6 hours, 12 hours, 18 hours and 24 hours after extubation |
| Time of extubation after surgery |
At time of extubation after surgery in postoperative period |
| Duration of ICU stay |
at the time of shifting out the patient from ICU |
| Duration of hospital say after surgery |
At the time of discharge of the patient from hospital after surgery |
| Cumulative post operative analgesics (paracetamol, fentanyl) consumed in first 24 hours after surgery |
At end of 24 hours after surgery |
| peak expiratory flow |
at end of 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2021 |
| Date of Study Completion (India) |
01/06/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ramanrajesh83@gmail.com].
- For how long will this data be available start date provided 31-10-2021 and end date provided 26-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Ultra-fast-tracking (UFT) in cardiac anesthesia refers to minimizing the duration of post-operative ventilatory support and ICU stay and early discharge from hospital. (1-4) This technique has advantage of reducing the post-operative respiratory complications, improved patient comfort, faster patient mobilization and better resource utilization.(1-3) Early extubation of patient’s trachea is the core component of UFT. In scientific literature, the definition of ‘early extubation’ for UFT has been used variably ranging from extubation in operating room to within 2-4 hours from end of surgery. (3) Use of short acting opioids and reduction in dose of opioids is essential for early awakening and extubation of patients. Use of regional anesthesia helps reduce the dose of opioid analgesics in several studies. (6-10). Pectoralis Nerve blocks (Pecs block) and TTP block are regional analgesic techniques suitable for providing analgesia for cardiac surgery.(11-12) Ultrasound guided TTPB has been used by Fujii et al in 20 patients undergoing elective cardiac surgery.(7) The authors recruited patients of either group aged between 18-90 years to either block group or standard care (no regional anaesthetic block was given). The authors found that the patients receiving block had lower pain scores at rest. There was no block related side effect in any patient. Use of Pecs Block for analgesia in patients for UFT in cardiac anaesthesia was assessed by Kumar et al.(6) Patients aged between 25 and 65 scheduled to undergo cardiac surgery using median sternotomy approach were divided into two groups. One group was given bilateral PEC block while the control group was given only parenteral analgesics for post-operative analgesia. Patients receiving the Pec block had shorter ventilatory support duration, had lower pain scores for first 24 hours, had lower rescue analgesic requirements and had higher inspiratory flow rates as compared to the patients of control group. 1. Nagre AS, Jambures NP. Comparison of immediate extubation versus ultrafast tracking strategy in the management of off-pump coronary artery bypass surgery. Ann Card Anaesth 2018;21:129-33 2. Taware M, Sonkusale M, Deshpande R. Ultra-fast-tracking in cardiac anesthesia “Our Experience†in a rural setup. J Datta Meghe Inst Med Sci Univ 2017;12:110-4 3. Cheng DC; Fast Track Cardiac Surgery Pathways : Early Extubation, Process of Care, and Cost Containment. Anesthesiology 1998;88:1429-33. 4. Gregory AJ, Grant MC, Manning MW, Cheung AT, Ender J, Sander M, et al. Enhanced Recovery After Cardiac Surgery (ERAS Cardiac) Recommendations: An Important First Step—But There Is Much Work to Be Done. J Cardiothorac Vasc Anesth. 2020;34:39-47. 5. Wong WT, Lai VK, Chee YE, Lee A. Fastâ€track cardiac care for adult cardiac surgical patients. Cochrane Database of Systematic Reviews 2016; 9: CD003587 6. Kumar KN, Kalyane RN, Singh NG, Nagaraja PS, Krishna M, Babu B, Varadaraju R, Sathish N, Manjunatha N. Efficacy of bilateral pectoralis nerve block for ultrafast tracking and postoperative pain management in cardiac surgery. Annals of cardiac anaesthesia. 2018;21:333-8. 7. Fujii S, Roche M, Jones PM, et al Transversus thoracis muscle plane block in cardiac surgery: a pilot feasibility study Regional Anesthesia & Pain Medicine 2019;44:556-60. 8. Mehta Y, Arora D, Sharma KK, Mishra Y, Wasir H, Trehan N. Comparison of continuous thoracic epidural and paravertebral block for postoperative analgesia after robotic-assisted coronary artery bypass surgery. Ann Card Anaesth 2008;11:91-6 9. Nanavati AJ, Prabhakar S. Fast-track surgery: Toward comprehensive peri-operative care. Anesth, Essays Res 2014;8:127–33. 10. Hammer GB, Ngo K, Macario A. A retrospective examination of regional plus general anesthesia in children undergoing open heart surgery. Anesth Analg 2000;90:1020-4. 11. Mittnacht AJ, Shariat A, Weiner MM, Malhotra A, Miller MA, Mahajan A et al. Regional techniques for cardiac and cardiac-related procedures. Journal of cardiothoracic and vascular anesthesia. 2019;33:532-46. 12. Caruso TJ, Lawrence K, Tsui BC. Regional anesthesia for cardiac surgery. Current Opinion in Anesthesiology. 2019;32:674-82. |