| CTRI Number |
CTRI/2024/07/069697 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two medicines as an add on to Local anaesthetics medication used in procedure |
|
Scientific Title of Study
|
A prospective randomized, comparative study of Dexmedetomidine Vs Dexamethasone as an adjuvant to Ropivacaine in Usg Guided Erector Spinae Plane Block for Patients Undergoing Laproscopic 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 |
Dr Uppala Eswar |
| Designation |
Junior Resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College, Ground floor, Room No G-12, Dept. of Anaesthesiology LLRM Medical College, Jagrati Vihar, Meerut
Uttar Pradesh
250004 India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7036856930 |
| Fax |
|
| Email |
uppalaeswar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sweta |
| Designation |
Associate professor |
| Affiliation |
LLRM Medical College |
| Address |
Dept. of Anaesthesiology, Room No G-12, Ground Floor, Near IT parking, LLRM Medical College, Jagrati Vihar, Meerut
Uttar Pradesh
250004 India
Meerut
UTTAR PRADESH
250004
India |
| Phone |
8750933442 |
| Fax |
|
| Email |
swetaanae@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Uppala eswar |
| Designation |
Junior resident |
| Affiliation |
LLRM Medical College |
| Address |
LLRM Medical College, Department of Anaesthesiology, Ground floor, Room No-G-12, Beside IT parking, Garh Road, Jagrati Vihar, Meerut
Meerut
UTTAR PRADESH
250004
India |
| Phone |
7036856930 |
| Fax |
|
| Email |
uppalaeswar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, LLRM Medical College, |
|
|
Primary Sponsor
|
| Name |
Dr Uppala Eswar |
| Address |
LLRM Medical College, Department of Anaesthesiology, Meerut, Uttar Pradesh-250004 |
| 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 Uppala Eswar |
Sardar Vallabai Patel Hospital |
Room No. 14 Ground floor, Beside IT Parking, Department of Anaesthesiology, LLRM Medical College
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
7036856930
uppalaeswar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Principal, LLRM Medical College, Meerut |
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 |
| Comparator Agent |
Inj Dexmedetomidine with Inj Ropivacaine
- Inj Dexamethasone 8 mg |
Inj Dexmedetomidine 50mcg or Inj Dexamethasone 8 mg with Inj Ropivacaine 0.2% 15 ml of Injection will be given Intramuscular (IM) Interfacial plane of erector spinae muscle and transverse process and Post operative pain assessment will be assessed at 5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 60 min, 120 min, 240 mins, 360 mins and 12th hour and 24th hour |
| Intervention |
Ultrasound guided Erector spinae plane block . |
Erector Spinae block will be given to all the participants of the study. The procedure will be done using ultrasound for more accuracy of the block. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I and grade II Patients
2. Age- 20 to 60 years of either sex
3. Weight of patient ranging 50-70 kg.
4. Patients undergoing elective laparoscopic cholecystectomy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal to ESPB,
2. ≥ Patients with ASA physical status III-IV,
3. Infection at injection site,
4. Coagulopathy or bleeding disorder, bradycardia, cardiac conduction block, were administered B-adrenergic antagonist or an antiplatelet agent,
s Any systemic illness like DM, HTN etc
6. 1st 2nd and 3rd deggree heart block
7. Known allergy or hypersensitivity to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the duration of postoperative analgesia |
Injection will be given and Post operative pain assessment will be assessed at 5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 60 min, 120 min, 240 mins, 360 mins and 12th hour and 24th hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesia consumption in 24 hrs.
2. Duration of sensory block
3. Any intraoperative or postoperative complication (Incidence of post op nausea and vomiting, shoulder pain, bradycardia etc.,)
4. postoperative Quality of Recovery Score(QoR)
|
In the recovery room, all patients will be given inj. Tramadol as per request. Total tramadol consumption in 24 hrs will be recorded. Post operative quality of recovery score (QoR) will be used for pain assessments at awakening ,1st,2nd ,4th, 6th, 12th and 24th h postoperatively. Patients will be questioned for shoulder pain and the incidence of nausea and vomiting |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
09/07/2024 |
| 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="6"
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 trial is to compare the effect of Inj Ropivacaine along with Inj. Dexmed and Inj Dexamethasone as an adjuvant in Erector spinae muscle block post lap cholecystectomy . We will be studying the efficacy and duration of the block in this study. |