| CTRI Number |
CTRI/2023/03/050677 [Registered on: 14/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Pain relieving effect of abdominal muscle plane block in laparoscopic gall bladder surgery with full anaesthesia |
|
Scientific Title of Study
|
Study of Analgesic Efficacy of External Oblique Muscle Plane Block after Laparoscopic Cholecystectomy under General Anaesthesia- a Prospective Randomised Controlled Double-Blind Academic Trial at KPC Medical College & Hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Subrata Ray |
| Designation |
Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830021157 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Ray |
| Designation |
Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830021157 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Ray |
| Designation |
Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Dept Of anaesthesiology , room No 232, KPC Medical College & Hospital
1F, Raja S C Mullick Road, Jadavpur
Kolkata
WEST BENGAL
700032
India |
| Phone |
9830021157 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College & Hospital
Jadavpur
Kolkata 700032 |
|
|
Primary Sponsor
|
| Name |
KPC Medical College & Hospital |
| Address |
KPC Medical College & Hospital
Jadavpur
Kolkata 700032 |
| Type of Sponsor |
Private 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 Subrata Roy |
KPC Medical College & Hospital |
Dept of Anaesthesiology Room No 232 KPC Medical College & Hospital
Jadavpur
Kolkata 700032
Kolkata
WEST BENGAL |
9830021157
raysubrata62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee KPC Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA grade I & II
|
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Oblique Muscle Plane Block |
External Oblique Muscle Plane Block
Duration of intervention 10 minutes |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I& II |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Patient undergoing emergency surgery
infection at the site of needle entry |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain relief with NRS score with 11 point score |
NRS score with 11 point score at 30mins, 1,6,12 and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Satisfaction score
and
Sensory loss of cold sensation to ice |
Satisfaction score at 12 and 24hrs
Sensory loss of cold sensation at every 30mins |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
17/03/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
External Oblique Muscle Plane Block (EXOP) is an adjuvant to systemic analgesics for adult patients undergoing laparoscopic cholecystectomy under general anaesthesia in the post operative perioid. Being relatively superficial muscle plane block it will be an easy to perform with less complications and equal or better analgesic efficacy. |