| CTRI Number |
CTRI/2024/08/073030 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of 2 different plane blocks(ESPB AND SAPB)for relieving post op pain in patients undergoing minimally invasive cardiac surgery |
|
Scientific Title of Study
|
A comparative evaluation of post operative pain between ultrasound guided serratus anterior plane block(SAPB) and erector spinae plane block (ESPB) in patient undergoing minimally invasive cardiac surgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrArpit raj |
| Designation |
Junior resident1 |
| Affiliation |
JawahalalNehru medical college |
| Address |
Department of Anesthesiology and critical care, jnmch,amu, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
6395693120 |
| Fax |
|
| Email |
arpitraj1803@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Drnadeem raza |
| Designation |
Assistant professor |
| Affiliation |
JawahalalNehru medical college |
| Address |
Department of Anesthesiology and critical care,Jnmc, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417795018 |
| Fax |
|
| Email |
nadeemraza03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drnadeem raza |
| Designation |
Assistant professor |
| Affiliation |
JawahalalNehru medical college |
| Address |
Department of Anesthesiology and critical care,Jnmc, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417795018 |
| Fax |
|
| Email |
nadeemraza03@gmail.com |
|
|
Source of Monetary or Material Support
|
| JawahalalNehru medical college and hospital, Amu, Aligarh,202002, India |
|
|
Primary Sponsor
|
| Name |
DrArpit Raj |
| Address |
Department of Anesthesiology and critical care JawahalalNehru medical college and hospital,amu,aligarh |
| 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 |
| Drarpit raj |
Department of Anesthesiology and critical care JawahalalNehru medical college and hospital |
Department of Anesthesiology and critical care Jnmch, amu, Aligarh
Aligarh
UTTAR PRADESH |
06395693120
arpitraj1803@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee (Regd.) JawahalalNehru medical college and hospital, faculty of medicine, Aligarh Muslim University, Aligarh,up |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ESPB (ERECTOR SPINAE PLANE BLOCK) |
30 ml of 0.25% Ropivacaine in plane of Erector Spinae muscle groups |
| Comparator Agent |
SAPB(SERRATUS ANTERIOR PLANE BLOCK) |
30 ml 0.5% ropivacaine on the same side of surgery post operatively in between Serratus anterior and Latissimus Dorsi |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient undergoing elective minimally invasive cardiac surgery via thoracotomy incision.
Age between 14-60 yes
BMI 18- 30 Kg/m2
Patient of either sex
Consent of patient/parents |
|
| ExclusionCriteria |
| Details |
Patient refusal
Extubation time more than 6 hrs
Patient with symptomatic CHF
Hypersensitivity to drug used
Skin infection at puncture site
Coagulation disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the degree of analgesia (time for first rescue analgesia)in postoperative period using SAPB AND ESPB |
After Extubation we will assess pain of the patient at 0hr,2hr,4hr,6hr,12hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 24 hours cumulative iPods consumption post intubation |
24 hours |
| Time to extubate |
6 hours |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
10/09/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/09/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="1" |
|
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 - NO
|
|
Brief Summary
|
Enhanced recovery after surgery (ERAS) are being implemented in almost all specialties of surgery, with cardiac surgery being no exception .One of Enhanced recovery after surgery (ERAS) programs the major components of ERAS protocols is pain control using multi-modal commonly faced ""opioid- -sparing’ analgesic regimens. Postoperative pain as a necessary in the postoperative anaesthetia problem and its management is Minimally invasive cardiac surgery has significant advantages compared with care. traditional sternotomy techniques. These include reduced tissue trauma, decreased Despite being less invasive than blood loss, and shorter length of hospital stay 12 traditional sternotomy, these approaches are associated with significant nociceptive inflammatory Pain *, which is traditionally, relied on high-dose opioid-based 2,34 regimens for pain control and the cardio-protective effect of opioids, Ieading to their widespread use. Adverse effects of opioids include respiratory depression, delirium, and gastrointestinal dysfunction, which are particularly problematic in the aging and comorbid population undergoing cardiac surgery. Post thoracotomy pain (PTP) adversely affects the depth of breathing and the ability to cough leading to hypoxemia, atelectasis and other postoperative respiratory impediments to an early recoverys Nowadays analgesic procedures that reduce opioid consumption and improve postoperative outcomes from minimally invasive cardiac surgery procedures are desirable. The aforementioned elucidation of the importance of ensuring effective post thoracotomy analgesia in conjunction with an early recovery continues to evoke interest in the regional analgesia approach to PTP management. While the intercostal nerve block (ICNB) has been extensively studied and employed for post thoracotomy analgesia, the literature on improved analgesia with fascial plane blocks such as serratus anterior plane block (SAPB) and Erector spine plane block (ESPB) is promising. We, therefore aim to compare the efficacy of ultrasound guided SAPB with the ESPB block in terms of postoperative pain and cumulative opioid consumption 1N 24 hr post extubation.
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