| CTRI Number |
CTRI/2024/03/064503 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
15/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ultrasound guided erector spinae plane block with or without dexmedetomidine on the postoperative pain in patients undergoing laparoscopic gallbladder removal |
|
Scientific Title of Study
|
Efficacy of ultrasound guided erector spinae plane block with or without dexmedetomidine on the postoperative analgesia in patients undergoing 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 Brahmacharimayum Diparani Devi |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences Imphal West |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9615959150 |
| Fax |
|
| Email |
atumbi10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. N. Ratan Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences Imphal West |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
|
| Fax |
|
| Email |
drnratansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brahmacharimayum Diparani Devi |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences Imphal West |
| Address |
Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West
Imphal West
MANIPUR
795004
India |
| Phone |
9615959150 |
| Fax |
|
| Email |
atumbi10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Regional Institute of Medical Sciences Imphal West Manipur |
|
|
Primary Sponsor
|
| Name |
Dr Brahmacharimayum Diparani Devi |
| Address |
Regional Institute of Medical Sciences Imphal West Manipur |
| 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 Brahmacharimayum Diparani Devi |
Regional Institute of Medical Sciences Imphal West Manipur |
Operation Theatre Complex (OT 3-4) Department of Anaesthesiology Regional Institute of Medical Sciences
Imphal West
MANIPUR |
9615959150
atumbi10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board Regional Institute of Medical Sciences Imphal West Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Administration of erector spinae plane block with 19ml 0.375 percent ropivacaine plus 1ml normal saline immediately after intubation over a total period of 5 minutes |
Study population group A will receive bilateral erector spinae plane block with 19ml 0.375 percent ropivacaine plus 1ml normal saline immediately after intubation over a total period of 5 minutes |
| Intervention |
Administration of erector spinae plane block with 19ml 0.375 percent ropivacaine plus 1ml (0.5 microgram per kg ) dexmedetomidine bilaterally |
Study population group B will receive bilateral erector spinae plane block with 19ml 0.375percent ropivacaine plus 1ml (0.5 micrograms per kg )
dexmedetomidine immediately after intubation over a total period of 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a.Patients of either gender,
b. American Society of Anaesthesiologists (ASA) physical status I or II ,
c. Age 18-60 years
d. BMI (Body mass index): 18-25kg/m |
|
| ExclusionCriteria |
| Details |
a.Patient refusal and allergic to study drugs (local anaesthetics)
b. Bleeding disorder-platelet count
less than 50,000/microlitre, prothrombin time more than 14 sec and International normalised ratio (INR) more than 1.5
c. Local site infection and with neurological deficits of lower limb and torso
d. Cardiac, respiratory diseases, kidney disorders, pregnancy and spinal deformity
and mental/cognitive impairment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Duration of analgesia (hours)
2.Time to first rescue analgesic
3.Total dose of rescue analgesics consumed in first 24 hours
4.Pain score using Visual analogue scale (VAS) at 0,6,12, 24 hours
(postoperative) |
Outcomes will be recorded at 0,6,12, and 24 hours. Data collected will be assessed at the end of one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic profile- pulse rate, systolic blood pressure (SBP), diastolic
blood pressure (DBP), mean arterial pressure (MAP)
2.Complications (postoperative):
a.Hypotension and Bradycardia
b.Shivering
c.Nausea & vomiting |
All outcomes will be continously recorded for every 0,6,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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 Yet Recruiting |
| 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
|
Postoperative pain control is a substantial problem with laparoscopic cholecystectomy ,a common surgical procedure.Erector spinae plane block (ESPB), a relatively new block has been shown to have beneficial effects on post operative analgesia in neuropathic pain , thoracic surgical procedures and upper abdominal surgeries.
The aim of this prospective randomized double blinded study is to compare the efficacy of ESPB with local anaesthetic 0.375 % ropivacaine with or without dexmedetomidine as an adjuvant in laparoscopic surgeries. A total of 60 patients scheduled to undergo laparoscopic cholecystectomy will be enrolled in the study and divided into two groups .According to a computer-generated randommization table, patients in group A will receive ESPB with only local anaesthetic,while those in group B will receive ESPB with local anaesthetic admixed with dexmedetomidine 0.5 microgram per kg.The data will collected,entered in the master chart, and analysed using the student’s ’t ’ test for continuous data and the chi-square test for categorical data,,as and where appropriate. |