| CTRI Number |
CTRI/2020/02/023451 [Registered on: 19/02/2020] Trial Registered Prospectively |
| Last Modified On: |
09/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain management in Laparoscopic cholecystectomy - Erector spinae block versus oblique subcostal transverse abdominus plane block |
|
Scientific Title of Study
|
Comparative study for post-operative pain management with Erector Spinal plane (ESP) block & oblique Sub costal transverse abdominis plane (OSTAP) block in patient undergoing laparoscopic cholecystectomy |
| Trial Acronym |
ESTA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shlok Saxena |
| Designation |
Postgraduate |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
OT complex, Department of Anesthesiology,Pradyumana Bal Memorial Hospital, KIMS,
KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
7411642092 |
| Fax |
|
| Email |
drshloksaxena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shlok Saxena |
| Designation |
Postgraduate |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
Ot complex, Department of Anesthesiology,Pradyumana Bal Memorial Hospital, KIMS, KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
7411642092 |
| Fax |
|
| Email |
drshloksaxena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shlok Saxena |
| Designation |
Postgraduate |
| Affiliation |
Kalinga Institute of Medical Sciences |
| Address |
OT complex, Department of Anesthesiology, Pradyumana Bal Memorial Hospital, KIMS, KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA
751024
India |
| Phone |
7411642092 |
| Fax |
|
| Email |
drshloksaxena@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pradyumana Bal Memorial Hospital, Kalinga Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology Kalinga Institute of Medical Sciences |
| Address |
KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha 751024 |
| 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 |
| Dr Shlok Saxena |
Pradyumna Bal Memorial Hospital Kalinga Institute of Medical Sciences |
OT complex, Department of Anesthesiology, KIMS, KIIT University, Chandaka Industrial Estate, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
7411642092
drshloksaxena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae block |
In sitting position USG landmarks, which include T7 transverse process and Erector spinae muscle will be identified. A 10 cm 21G needle will be inserted in the plane in caudal direction until the needle tip hits T7 transverse process. After hydro dissection with 2-3 ml of isotonic saline, 20 ml of 0.2% ropivacaine and 4mg dexamethasone solution will be deposited to perform block. The same procedure is repeated on the other side. |
| Comparator Agent |
Oblique Subcostal Transverse abdominus plane block |
Patients receive USG guided TAP block with an oblique subcostal approach in supine position. 20ml of 0.2% ropivacaine and 4mg dexamethasone solution will be given between rectus abdominis and transversus abdominis muscle along the subcostal line on both sides. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive hospitalized patient scheduled for laparoscopic cholecystectomy surgery |
|
| ExclusionCriteria |
| Details |
1. Infection at the injection site of block
2. Known allergy to local anesthetics
3. Chronic Opioid consumption
4. Conversion to open cholecystectomy
5. Hypertension
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Total amount of opioid use in 1st 24hrs of postoperative period.
2.Time to first rescue analgesia.
|
baseline, 24hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Presence of postoperative nausea, vomiting and respiratory depression
2.Patient satisfaction score
|
postoperative period 1hr , 4hr, 8hr, 16hr, 20hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/02/2020 |
| Date of Study Completion (India) |
12/02/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Laparoscopic cholecystectomy, a commonly performed
minimally invasive surgery causes moderate to severe postoperative pain.
Somatic pain occurs from trocar entry incision site
and visceral pain due to surgical intervention and residual CO2 intraperitoneal
cavity.
Ultrasound guided OSTAP block provides analgesia
for somatic pain and parietal pain of almost entire anterior abdomen, it fails
to relieve visceral pain
USG guided ESP block is a novel technique targeting
the ventral rami, dorsal rami, rami communicanties of spinal nerves thus
alleviating both somatic & visceral pain.
In our study we compare analgesic efficacy of ESP with
OSTAP
|