| CTRI Number |
CTRI/2021/02/030907 [Registered on: 01/02/2021] Trial Registered Prospectively |
| Last Modified On: |
28/01/2021 |
| 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
|
Post operative analgesic consumption with or without sono-guided Erector Spinae Plane Block in patients undergoing abdominal surgery: A randomised, controlled, interventional study. |
|
Scientific Title of Study
|
Post operative analgesic requirement with or without sono-guided erector spinae plane block in patients undergoing abdominal surgery: A randomized, controlled interventional study, SMS Hospital, Jaipur |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushil K Bhati |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Sawai Man Singh Medical College and Attached Group of Hospitals, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
drsushilbhati@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushil K Bhati |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Sawai Man Singh Medical College and Attached Group of Hospitals, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
drsushilbhati@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushil K Bhati |
| Designation |
Senior Professor |
| Affiliation |
Sawai Man Singh Medical College |
| Address |
Sawai Man Singh Medical College and Attached Group of Hospitals, JLN Marg, Adarsh Nagar, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414779786 |
| Fax |
|
| Email |
drsushilbhati@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesiology, SMS Medical College and Attached Group of Hospitals, Jaipur 302004 |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology SMS Medical College and Attached Group of Hospitals |
| Address |
JLN Marg, Gangawal Park, Adarsh Nagar, Jaipur 302004 |
| Type of Sponsor |
Government 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 |
| Divyashree S |
Dept of Anaesthesiology |
SMS Medical College, JLN Marg, Gangawal Park, Adarsh Nagar, Jaipur 302004
Jaipur
RAJASTHAN |
9483781188
divyaprakashbhat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, (2) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum, (3) ICD-10 Condition: K432||Incisional hernia without obstruction or gangrene, (4) ICD-10 Condition: K689||Other disorders of retroperitoneum, (5) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (6) ICD-10 Condition: K863||Pseudocyst of pancreas, (7) ICD-10 Condition: C250||Malignant neoplasm of head of pancreas, (8) ICD-10 Condition: C23||Malignant neoplasm of gallbladder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Patients undergoing abdominal surgeries receiving multi modal analgesia |
| Intervention |
Erector Spinae Plane Block |
Erector Spinae Plane Block under ultrasound guidance using 25ml of 0.25% ropivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to American Society of Anesthesiologists (ASA):
Grade I: Without co-morbid conditions
Grade II: Controlled co-morbid conditions
Grade III : Poorly controlled co-morbid conditions
2.Weight 40-80 kg
|
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study
2.H/O allergic reactions to local anesthetics
3.Patients on anticoagulant therapy and H/O coagulation disorders
4.Local infection at the proposed site of puncture for Erector Spinae Plane block
5.Chronic use of opioids or corticosteroids.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in mean analgesic dose required post operative period in both groups |
12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the time of first rescue analgesic in both groups. |
12 hours , and every 1 hour thereafter upto 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2021 |
| 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
|
Nil. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regional anaesthesia is highly effective both
for the surgical procedure and postoperative pain management. Abdominal surgeries can lead to significant
postoperative pain. In these patients, different regional anesthesia
techniques play an important role in multimodal analgesia plans. Non-opioid
analgesia techniques are especially important in aging populations when
comorbidities are considered. Erector Spinae Plane block (ESPB), first
described by Forero et al for analgesia in thoracic neuropathic pain has
also been reported for the management of other causes of acute and
postoperative pain. In this study, we aim to determine the
postoperative analgesic effect of USG guided Thoracic ESPB (T-ESPB) in patients
undergoing abdominal surgery. |