| CTRI Number |
CTRI/2025/02/081249 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| 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
|
Thoracic epidural analgesia and ultrasound guided erector spinae plane block for pain control after Laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparision of thoracic epidural analgesia and ultrasound guided erector spinae plane block for post-operative pain control following laparoscopic cholecystectomy :A RANDOMIZED CLINICAL TRIAL |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LIPPI LOLLEN |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences,Imphal West |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences,
Imphal West
MANIPUR
India
Imphal West
MANIPUR
795004
India |
| Phone |
8974356433 |
| Fax |
|
| Email |
lollenlippi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences,Imphal West |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences,
Imphal West
MANIPUR
India
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laithangbam Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences,Imphal West |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences,
Imphal West
MANIPUR
India
Imphal West
MANIPUR
795004
India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Regional Institute of Medical Sciences,Imphal West
MANIPUR
India
Pin code-795004 |
|
|
Primary Sponsor
|
| Name |
Lippi Lollen |
| Address |
Regional Institute of Medical Sciences,Imphal West
MANIPUR
India |
| 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 |
| Lippi Lollen |
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
Imphal West
MANIPUR |
8974356433
lollenlippi@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: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Administration of erector spinae plane block with 15ml 0.2 percent ropivacaine plus 0.75ml(7.5microgram) dexmedetomidine bilaterally immediately after intubation over a total period of 10 minutes |
Study population group will receive bilaterally ultrasound guided Erector Spinae Plane block with 15ml 0.2percent plus 7.5microgram dexmedetomidine immediately after intubation over a total period of 10 minutes |
| Comparator Agent |
Administration of Thoracic epidural analgesia with 15ml 0.375 percent Ropivacaine plus 0.75ml(7.5microgram)dexmedetomidine |
Study population group A will recieve Thoracic epidural analgesia with 15ml 0.375percent Ropivacaine plus 0.75ml(7.5microgram)
dexmedetomidine immediately after intubation over a period total period of 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a. Patients of either sex
b. Age group- 18 to 60 yrs.
c. American society of anesthesiologists (ASA) Grade I or Grade II
d. BMI: 18 to 30 kg/m2
e. Weight:40-70 kg
|
|
| ExclusionCriteria |
| Details |
a. Patient refusal
b. An allergy to local anaesthetics
c. Contraindication to epidural anaesthesia (abnormal coagulation status, a local infection, preexisting neurological deficit of torso or lower limb, and spinal diseases)
d. Pregnancy
e. Cognitive impairment
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant 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 24hours
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 and vomiting
|
All outcomes will be continously recorded for every 0,6,12 and 24 hours.Data collected will be assessed at the end of one year |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
08/03/2025 |
| 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. Thoracic epidural analgesia was gold standard for reducing pain after thoracic and upper abdominal surgeries. Erector spinae plane block(ESPB),a relatively a 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 single blinded study is to compare thoracic epidural analgesia and ultrasound guided erector spinae plane block for post operative management following laparoscopic cholecystectomy using local anaesthetic ropivacaine with dexmedetomidine.
A total of 80 patients ,aged 18-60 years belonging to American society of Anaesthesiologists(ASA) I and II scheduled to undergo laparoscopic cholecystectomy will be enrolled in the study and divided into two groups. According to compture generated table,patients in group A will receive Thoracic epidural analgesia with local anaesthetic 0.375% ropivacaine and 7.5 microgram dexmedetomidine and the group B will receive ESPB with local anaesthetic 0.187% ropivacaine with 7.5 microgram dexmedetomidine bilaterally. The data will be collected ,entered in master chart ,analysed using the student’s ’t’ test for continuous data and the chi-square test for categorical data as and where appropriate.The findings and observations made during the entire study will be tabulated,graphically depicted whenever possible,statistically analysed and inference drawn. |