| CTRI Number |
CTRI/2024/07/070260 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Post operative analgesia efficacy comparision between two Regional Anesthetic Blocks ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of two nerve block, Erector spinae plane block and Oblique subcostal transversus abdominis plane block on pain relieve after gall bladder surgery |
|
Scientific Title of Study
|
Efficacy of ultrasound guided erector spinae plane block and ultrasound guided oblique sub costal transversus abdominis plane block for postoperative analgesia in laparoscopic cholecystectomy A Comparative Study |
| 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 Amitesh kumar singh |
| Designation |
pg resident |
| Affiliation |
Pt. J N M Medical college , Raipur |
| Address |
Departmemt of anaesthesiology and pain management
Pt. J N M medical college,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770808177 |
| Fax |
|
| Email |
arcane44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Professor |
| Affiliation |
Pt. J N M Medical college , Raipur |
| Address |
Departmemt of anaesthesiology and pain management
Pt. J N M medical college,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amitesh kumar singh |
| Designation |
pg resident |
| Affiliation |
Pt. J N M Medical college , Raipur |
| Address |
Departmemt of anaesthesiology and pain management
Pt. J N M medical college,Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8770808177 |
| Fax |
|
| Email |
arcane44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesiology and pain management,
Pt JNM medical college ,raipur 492001 |
|
|
Primary Sponsor
|
| Name |
Dr Amitesh kumar singh |
| Address |
Department of anaesthesiology and pain management,
Pt J N M medical college ,Raipur,
Chhattisgarh ,India , pin 492001 |
| 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 Amitesh kumar singh |
Dr Bhim Rao Ambedkar Hospital ,Raipur |
Department of anaesthesiology and pain management
Pt J N M medical college raipur
Raipur
CHHATTISGARH |
8770808177
arcane44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt J.N.M Medical College Raipur C G |
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 |
Ultrasound‑guided erector spinae plane block |
ESP block will be performed in lateral position, erector spinae muscle will be identified superficial to the tip of the T9 transverse process.
single dose 40mg,20 mL of solution inj ropivacaine 0.2 percent and inj dexamethasone 4mg will be injected deep to the erector spine muscle via 22G 8cm needle
this is repeated on other side
total dose 80mg of ropivacaine 0.2 percent
and 8mg of dexamethasone.
effect is observed upto 24hrs
|
| Comparator Agent |
ultrasound‑guided oblique subcostal transversus abdominis plane block |
OSTAP block will be performed in supine position , After identifying the appropriate fascial plane
single dose 40mg,20 mL of solution inj ropivacaine 0.2 percent and inj dexamethasone 4mg will be injected between the rectus abdominis muscle and the transversus abdominis muscle via 22G 8cm needle
this is repeated on other side
total dose 80mg of ropivacaine 0.2 percent
and 8mg of dexamethasone.
effect is observed upto 24hrs
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients aged 18 yrs to 70yrs scheduled to undergo laparoscopic cholecystectomy
patients with ASA I –II |
|
| ExclusionCriteria |
| Details |
Patients with bleeding disorders
Patients on anticoagulants
Pre-existing cardiovascular disease, Hypertension, hepatic and renal failure
Advanced psychiatric illness
Allergy to local anaesthetics
Obesity BMI more than 30
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimation of total no of doses of 1st rescue analgesic required during first 24 hrs postoperatively |
24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 estimation of total duration of block in terms of requirement of 1st rescue analgesia
2 Mean NRS score at specific time points postoperatively.
3 Intra operative opioid requirement
4 Total number of 2nd line rescue analgesic dose required during first 24 hrs postoperatively
5 Patient satisfaction score -Likert scale (5 point)
6 Documentation of any complications in 1st 24 hrs postoperatively
|
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
18/07/2024 |
| 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
|
This study is a randomized, single blind, parallel group trial comparing the A clinical trial to study analgesic effect of two regional block, Erector spinae plane block and Oblique subcostal transversus abdominis plane block in patients undergoing laparoscopic cholecystectomy that will be conducted in India. The primary outcome measures will be Estimation of total no of doses of 1st rescue analgesic required during first 24 hrs postoperatively. The secondary outcomes will be estimation of total duration of block in terms of requirement of 1st rescue analgesia , Mean NRS score at specific time points postoperatively, Intra operative opioid requirement ,Total number of 2nd line rescue analgesic dose required during first 24 hrs postoperatively, Patient satisfaction score -Likert scale (5 point),Documentation of any complications in 1st 24 hrs postoperatively. |