| CTRI Number |
CTRI/2023/08/056800 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
21/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Compare the pain relief effect of dexmedetomidine and dexamethasone as an additive to ropivacaine in ultrasound guided block for gall bladder surgeries |
|
Scientific Title of Study
|
Compare the analgesic effect of dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound guided erector spinae plane block for laparoscopic 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 |
Ezhukattil Reshma James |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415, BL Taneja Block, 4th floor ,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8076987148 |
| Fax |
|
| Email |
ezhukattilreshma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelam Prasad |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 305, BL Taneja Block, 3rd floor ,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7982903955 |
| Fax |
|
| Email |
nprasadgovil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ezhukattil Reshma James |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415, BL Taneja Block, 4th floor ,Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8076987148 |
| Fax |
|
| Email |
ezhukattilreshma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak ,G.N.E.C.,G.I.P.M.E.R Hospitals,New Delhi |
| Address |
Bahadur Shah Zafar Marg, near Delhi Gate, Maulana Azad Medical College Campus, Balmiki Basti, New Delhi, Delhi 110002 |
| 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 |
| Ezhukattil Reshma James |
Lok Nayak Hospital |
Operation Theater Block,Lok Nayak Hospital,JLN MARG 110002
Central
DELHI |
8076987148
ezhukattilreshma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K81||Cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound(USG)guided Erector Spinae Plane Block (ESPB) [0.2% ropivacaine with dexamethasone(10mg)] |
USG guided ESPB will be given bilaterally to patients undergoing laparoscopic cholecystectomy using 0.2% ropivacaine with dexamethasone(10mg).The procedure takes 10-15 mins to perfom. Patients are followed up till 24 hrs |
| Comparator Agent |
Ultrasound(USG)guided Erector Spinae Plane Block (ESPB)[0.2% ropivacaine with dexmedetomidine (0.5mcg/kg)] |
USG guided ESPB will be given bilaterally to patients undergoing laparoscopic cholecystectomy using 0.2% ropivacaine with dexmedetomidine (0.5mcg/kg). Procedure takes 10-15 mins and patients are followed up for 24hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1)18 to 65 years of age undergoing laparoscopic cholecystectomy
2)Patients of ASA I and II.
|
|
| ExclusionCriteria |
| Details |
1)Patient refusal.
2)Bleeding diathesis.
3)Local skin infection at the site of block.
4)Psychiatric disorder or risk of psychiatric disease.
5)Laparoscopic cholecystectomy turned to open cholecystectomy.
6)Any allergy to local anaesthetics or adjuvants dexmedetomedine/dexamethasone.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain using NRS score at various time intervals in both groups. |
0 mins
30 mins
1 hours
2 hours
6 hours
12 hours
24hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)The time at which the first rescue analgesia will be requested post operatively in both groups
2) Total amount of analgesic consumption within 24 hours postoperatively in both groups
3) Time of initiation of ambulation.
4) Respiratory Function(FEV1, FVC, FEV1/FVC & PEFR) pre-operatively and24hrspost-operatively using hand held spirometer.
5) Incidence of PONV.
6) Patient satisfaction.
|
Within 24 hr |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/08/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We are comparing the analgesic effect of dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound guided erector spinae plane block for laparoscopic cholecystectomy in patients between the age of 18 to 65 yrs. Erector spinae plane block will be given bilaterally before standard general anaesthesia induction to patients undergoing laparoscopic cholecystectomy .The aim of the study is to compare the analgesic effect of two groups .Two groups are DX- 0.2% ropivacaine with dexamethasone(10mg) , DM - 0.2% ropivacaine with dexmedetomidine (0.5mcg/kg). patients will be assigned into two groups by randomisation using lottery method, into groups DX and DM. Postoperative pain using NRS score at various time intervals in both groups will be noted, also 1)The time at which the first rescue analgesia will be requested post operatively in both groups 2) Total amount of analgesic consumption within 24 hours postoperatively in both groups 3) Time of initiation of ambulation. 4) Respiratory Function(FEV1, FVC, FEV1/FVC and PEFR) pre-operatively and24hrspost-operatively using hand held spirometer. 5) Incidence of post operative nause and vomiting PONV6) Patient satisfaction will also be noted.
|