| CTRI Number |
CTRI/2022/06/043314 [Registered on: 16/06/2022] Trial Registered Prospectively |
| Last Modified On: |
15/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to study the Efficacy of pain relief from erector spinae plane block for patients undergoing abdominal surgery
|
|
Scientific Title of Study
|
A study of assess the efficacy of ultrasound guided bilateral erector spinae block(ESPB) for abdominal surgery under general / spinal anaesthesia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
suneel ganganna ampragundi |
| Designation |
post graduate student |
| Affiliation |
Jawaharlal Nehru medical college and hospital |
| Address |
Department of anaesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9743383462 |
| Fax |
|
| Email |
suneelga628@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college, Ajmer |
| Address |
Department of anaesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kavita Jain |
| Designation |
Senior Professor |
| Affiliation |
JLN medical college, Ajmer |
| Address |
Department of anaesthesiology New OT JLN medical college Ajmer
Ajmer
RAJASTHAN
305001
India
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414006151 |
| Fax |
|
| Email |
drkavitajain15@gmail.com |
|
|
Source of Monetary or Material Support
|
| JLN MEDICAL COLLEGE AJMER
|
|
|
Primary Sponsor
|
| Name |
JLN MEDICAL COLLEGE AJMER |
| Address |
Department of anaesthesiology, JLN medical college Ajmer,
Rajasthan |
| 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 |
| Dr suneel ganganna ampragundi |
JLN medical college |
New OT Department of
anaesthesiology JLN
medical college
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN |
9743383462
suneelga628@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,J.L.N. medical college Ajmer, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K400||Bilateral inguinal hernia, with obstruction, without gangrene, (2) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (3) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (4) ICD-10 Condition: K810||Acute cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
erector spinae plan block with general anaesthesia / spinal anaesthesia |
Erector spinae plane Block
using ROPIVACAINE 0.25% 15
ml + 15 ml bilaterally with dexmedetomidine 1mcg /kg at targeted transverses process of vertebra)is given once below erector spinae muscle, above the transverse process using usg guided technique. block is given before giving spinal or general anaesthesia
only ONCE to the
patient of study . Duration of study is 72 hrs post operation |
| Comparator Agent |
Without block |
Abdominal surgeries under spinal/ general anaesthesia without giving any erector spinae block. Duration of study is 72 hrs post operation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 18 and 60 years, Body weight 30 to 80kg , Patients belonging to ASA (American Society of Anaesthesiologists) class 1 and 2 Patients undergoing
abdominal surgery of duration 1 to 2 hours in theatre with
haemoglobin atleast 9 gm/dl, Patient free from any associated
acute or chronic systemic illness |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
Uncooperative patients
Patient with chronic pain or on long-term analgesics
Any known hypersensitivity or contraindication to bupivacaine
Local pathology at the site of injection or disability limiting the
performance of block,(deformity of spine)
Patients receiving beta blockers or cardiac drugs.
History of convulsion, allergy to the drug used, bleeding disorder,
severe neurological deficit, thyroid disorder
Patient with history of respiratory, cardiac, hepatic or renal disease
(necessitating classification in ASA Class III or above)
Patients having a history of significant neurological, psychiatric, or
neuromuscular disorders
Pregnant, lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of Number and frequency of
postoperative analgesia required in both the
groups for First 36 hours Postoperatively
To assess the effective analgesia by visual
analog scale (VAS) score |
Around 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess hemodynamic changes
to assess and compare the adverse effect
to assess sensory and motor block if any in espb |
around 1 year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2022 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of our study is to assess the efficacy of erector spinae plane block (ESPB) for post operative analgesia in patients undergoing abdominal surgery under general / spinal anaesthesia using Ropivacaine (0.25%) with dexmedetomidine by creating a comparison with those without the block |