| CTRI Number |
CTRI/2024/03/063808 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| 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
|
Comparing two blocks one where local anaesthetic is injected between two muscles in back and another where local anaesthetic is injected between two muscles in abdomen for post operative pain relief in laproscopic cholecystectomy |
|
Scientific Title of Study
|
Comparison of ultrasound guided erector spine block and oblique subcoastal transverse abdominis block for postoperative analgesia after laproscopic cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manisha Singh M S |
| Designation |
Post graduate |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology,
Bangalore medical college and research institute,New Thargupet Bangalore
Department of Anesthesiology,
Bangalore medical college and research institute,New Thargupet Bangalore
Bangalore
KARNATAKA
560002
India |
| Phone |
9845377358 |
| Fax |
|
| Email |
manishasingh7715@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramachandraiah R |
| Designation |
Professor |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology,
Bangalore medical college and research institute, New Thargupet, Bangalore.
Department of Anesthesiology,
Bangalore medical college and research institute, New Thargupet, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9845377358 |
| Fax |
|
| Email |
ramachandraiah090@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Singh M S |
| Designation |
Post graduate student |
| Affiliation |
Bangalore medical college and research institute |
| Address |
Department of Anesthesiology
Bangalore medical college and research institute,New Thargupet, Bangalore.
Department of Anesthesiology
Bangalore medical college and research institute, New Thargupet, Bangalore.
Bangalore
KARNATAKA
560002
India |
| Phone |
9845377358 |
| Fax |
|
| Email |
manishasingh7715@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology Bangalore medical college and research institute KR market Bangalore 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore medical college and research institute |
| Address |
Bangalore medical college and research institute, New Thargupet,Bangalore |
| 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 |
| Ramachandraiah R |
Bangalore medical college and research institute |
Department of Anesthesiology Bangalore medical college and research institute KR market Bangalore
Bangalore
KARNATAKA |
9845377358
ramachandraiah090@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (2) ICD-10 Condition: K811||Chronic cholecystitis, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.25% bupivacaine in ultrasound guided erector spinae plane block |
Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided erector spinae plane block for postoperative analgesia in patients undergoing laproscopic cholecystectomy before extubation. |
| Comparator Agent |
0.25% bupivacaine in ultrasound guided oblique subcoastal transverse abdominis plane block. |
Single shot of 20 ml of 0.25% bupivacaine will be administered under ultrasound guided oblique subcoastal transverse abdominis plane block for postoperative analgesia in patients undergoing laproscopic cholecystectomy before extubation . |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give informed consent
2. Patients aged between 21-60 years of age of either gender.
3. Patients of ASA Grade I and ASA Grade II
4. Patients undergoing elective laproscopic chlolecystectomy. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia in 24 hour post operative period. |
Duration of analgesia in 24 hour post operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative rescue analgesia requirement for 24 hours.
evaluate the adverse effects of both the blocks |
First 24 hours after block |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laproscopic cholecystectomy ispreferred surgery due to its minimal invasive nature. Despite of being minimal invasive procedure it produces significant postoperative pain. Multimodal approach to postoperative pain management include local infiltration, peripheral nerve block’ neuroaxial analgesia, analgesic drugs with different mechanism that gives synergistic effect on pain management. Ultrasound guided erector spinae plane block ( ESPB) block mainly acts on both ventral and dorsal rami and rami communicantes of spinal nerve hence effective on both visceral and somatic pain. Oblique subcoastal transverse abdominis plane block (OSTAPB) is modification of transverse abdominis plane block(TAP) and is recently described regional analgesia technique for supraumbilicalsurgeries like laproscopic cholecystectomy. This study is designed to compare ultrasound guided ESPB and OSTAPB for postoperative analgesia after laproscopic cholecystectomy.
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