| CTRI Number |
CTRI/2023/02/049809 [Registered on: 17/02/2023] Trial Registered Prospectively |
| Last Modified On: |
16/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy of pre operative Bilateral Erector Spinae Plane Block for post operative pain relief following laparoscopic surgeries |
|
Scientific Title of Study
|
Efficacy of Pre-emptive Ultrasound guided bilateral Erector
Spinae Plane Block for Post-operative analgesia following
Laparoscopic Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANKITHA J HIREMATH |
| Designation |
POST GRADUATE |
| Affiliation |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9980741849 |
| Fax |
|
| Email |
anku3025@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR HARSOOR S S |
| Designation |
HEAD OF THE DEPARTMENT AND PROFESSOR |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9845279426 |
| Fax |
|
| Email |
harsoorss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ANKITHA J HIREMATH |
| Designation |
POST GRADUATE |
| Affiliation |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, K G HALLI, BENGALURU- 560045
Bangalore
KARNATAKA
560045
India |
| Phone |
9980741849 |
| Fax |
|
| Email |
anku3025@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU |
|
|
Primary Sponsor
|
| Name |
Dr Ankitha J Hiremath |
| Address |
DEPATMENT OF ANESTHESIOLOGY, DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU |
| 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 ANKITHA J HIREMATH |
DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL |
Department of Anaesthesiology,
OT complex, 1st floor.
Bangalore
KARNATAKA |
9980741849
anku3025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BILATERAL ERECTOR SPINAE PLANE BLOCK |
Patients posted for elective laparoscopic surgeries, will be given ultrasound guided erector spinae plane block using Bupivacaine 0.25% 20 ml on each side prior to the commencement of surgery |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for elective laparoscopic surgeries.
2. Age 18 years and more
3. American society of Anaesthesiologists class I and II |
|
| ExclusionCriteria |
| Details |
1. Patietnts with history of known allergy to bupivacaine
2. Alcoholism, drug abuse, psycological or other emotional problems that are likely to invalidate the informed consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of pre-emptive ultrasound guided bilateral Erector Spinae
Plane Block(ESPB) with bupivacaine for post-operative analgesia in patients
undergoing laparoscopic surgeries |
From the time of block till the time of request of the first dose of rescue analgesia by the patient(within 24 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see for the presence of post operative nausea and vomiting, time to
ambulation(able to walk with or without support) and the total need of rescue
analgesic in the first 24 hours after surgery. |
From the time of block upto 24 hours after the block |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
27/02/2023 |
| 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="6"
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
|
Pain in the post operative period is one of the major complaints which impedes recovery of the patient from anaesthesia and surgery. The components of post operative pain include- Somatic pain, Visceral pain, Referred pain. Laparoscopic surgery is a minimally invasive surgery. Although minimally invasive, the amount of pain the patient suffers from in the immediate post-operative period is quite significant. Techniques like Thoracic Epidural Analgesia (TEA), Thoracic paravertebral block, Quadratus lumborum block, Rectus sheath block (RSB) have been previously used for providing post-operative analgesia following Laparoscopic Cholecystectomy. However, these techniques are associated with major complications. Erector Spinae Plane Block (ESPB) is a interfascial plane block. A feature unique to Erector Spinae Plane Block is that no nerve or plexus needs to be identified to administer the block. This block targets the space between Erector Spinae Sheath and Transverse process of the vertebra. The local anaesthetic injected spreads craniocaudally blocking multiple vertebral levels. The drug also spreads anteriorly blocking the dorsal rami, ventral rami and also the rami communicates. In this background the research question of the present study is to evaluate the efficacy of ultrasound guided bilateral erector spinae plane block using bupivacaine for post operative analgesia following laparoscopic surgeries. |