| CTRI Number |
CTRI/2019/09/021305 [Registered on: 18/09/2019] Trial Registered Prospectively |
| Last Modified On: |
28/10/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
It is a study to see the effect of giving local anaesthesia drug in the intercostal space to block pain carrying nerves near the mid chest bone for reducing the pain after heart operation. it will be done using a imaging device for better visualization of the nerves. |
|
Scientific Title of Study
|
ULTRASOUND GUIDED PARASTERNAL MODIFIED INTERCOSTAL NERVE BLOCK: ROLE AS A PREEMPTIVE ANALGESIC ADJUNT IN FAST TRACKING FOR MITIGATING POSTOPERATIVE STERNOTOMY PAIN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SCT/IEC/1267/AUG2018 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
santhosh |
| Designation |
SENIOR RESIDENT |
| Affiliation |
SCTIMST |
| Address |
DEPARTMENT OF ANAESTHESIA
SCTIMST
TRIVANDRUM
695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9894462248 |
| Fax |
|
| Email |
santhoshvilvan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBINSUKESAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SCTIMST |
| Address |
DEPARTMENT OF ANAESTHESIA
SCTIMST
TRIVANDRUM
695011
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8289983726 |
| Fax |
|
| Email |
subin@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
santhosh |
| Designation |
SENIOR RESIDENT |
| Affiliation |
SCTIMST |
| Address |
DEPARTMENT OF ANAESTHESIA
SCTIMST
TRIVANDRUM
695011
KERALA
695011
India |
| Phone |
9894462248 |
| Fax |
|
| Email |
santhoshvilvan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SREE CHITRA TIRUNAL INSTITUTE OF MEDICAL SCIENCES AND TECHNOLOGY(SCTIMST)
MEDICAL COLLEGE POST
TRIVANDRUM
KERALA
INDIA-695011 |
|
|
Primary Sponsor
|
| Name |
SCTIMST |
| Address |
DEPARTMENT OF ANAESTHESIA
SCTIMST |
| 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 |
| SANTHOSH |
SCTIMST |
DEPARTMENT OF ANAESTHESIA
BLOCK C
SCTIMST
TRIVANDRUM
Thiruvananthapuram
KERALA |
9894462248
santhoshvilvan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR189INSTKL2013RR16 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I252||Old myocardial infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NA |
| Intervention |
PARASTERNAL INTERCOSTAL NERVE BLOCK |
ULTRASOUND GUIDED INTERCOSTAL NERVE BLOCK.
IT IS A SINGLE SHOT INJECTION TECHNIQUE WHERE 1 ML OF LOCAL ANAESTHETIC AGENT LEVOBUPIVACAINE WILL BE INJECTED AROUND THE INTERCOSTAL NERVE USING ULTRASOUND GUIDANCE,BEFORE SURGICAL INCISION. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
CABG
40-70 YRS |
|
| ExclusionCriteria |
| Details |
Emergency Surgeries.
Redo-surgeries.
Open Sternum
Left Ventricular Ejection Fraction < 35%
Preoperative use of narcotics or illicit drug abuse.
History of chronic intractable non-cardiac pain.
Liver or Kidney disease
Allergy to Amide group of anaesthetics, Morphine or Fentanyl.
Arrhythmia history or rhythm disturbances documented in ECG.
Haemodynamically unstable patients already on preoperative inotropic support or
Intra-arterial balloon pumps (IABP).
Anticipated surgery or surgery lasting more than 6hrs.
Intubation time more than 12hrs or planned for overnight ventilation.
Patients refusing to participate.
Patients refusing the offered therapeutic options in either group.
Patients refusing for parting with medical data for analysis.
Patients refusing to participate after the start of study and desire to leave the study at any point of time.
Patients currently enrolled in another study.
Patients with inability to provide informed written consent.
Inability to complete Pain assessments.
Post-operative complications with underlying cardio-respiratory cause requiring return to operative room for re-explorations or reinstitution of mechanical ventilation.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters:
11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods:
a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
|
Quality and effectiveness of pain relief will beevaluated for 48 hrs after the surgery with routine in-hospital analgesic protocol using following parameters:
11-point 0-10 Verbal Numeric RatingEffects of the blockade on sedation, ventilation and requirement of concomitant analgesics will be assessed using following methods:
a) Alertness of patients in peri-tracheal extubation period, as assessed by Ramsay Sedation score in the initial 48 hours after the block.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Over-sedation leading to ETCO2 or PaCO2 build up during the ventilator weaning phase or peri-tracheal extubation period
2. Any requirement for temporary discontinuation of opioid infusion.
3. Any postoperative requirement for other supplemental analgesics
|
4 HRLY |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/09/2019 |
| Date of Study Completion (India) |
27/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Design: Prospective, Double Blinded Intervention study Setting: A tertiary referral centre, a university
hospital and single-centre (SCTIMST).
90 Patients coming
for elective CABG surgery will be randomized into two groups and a ultrasound
guided parasternal modified intercostal nerve block will be performed either
with 0.5%levobupivacaine or saline. All other routine standard anaesthetic and
analgesic protocols will be followed intraoperatively and postoperatively.
Objective of the study would be to do
1.
To assess the quality and
effectiveness of postoperative pain relief offered by ultrasound guided single
shot Parasternal modified-intercostal nerve block after tracheal extubation,
when the block would be administered before surgical incision providing
preemptive analgesia.
2.
Effects of the blockade on
sedation, ventilation and requirement of concomitant analgesics
To assess the patient cooperation and patient
comfort while performing the deep inspiratory exercises, coughing, and
incentive spirometry, in the immediate post Tracheal-extubation and period unto
48 Hrs. post-surgery |