| CTRI Number |
CTRI/2020/12/029526 [Registered on: 03/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Postoperative Pain management :Interscalene block versus Suprascapular with Infraclavicular block for Arthroscopic shoulder cuff repair |
|
Scientific Title of Study
|
Comparing Postoperative Analgesia:Interscalene block versus Suprascapular with Infraclavicular block for Arthroscopic shoulder cuff repair. |
| Trial Acronym |
SSB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhuri Dadke |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti hospital |
| Address |
Department of Anaesthesia,first floor Sior OT
Sancheti hospital
11,12 Thube Park,
16,Shivajinagar,
Pune
411005
Department of Anaesthesia,first floor Sior OT
Sancheti hospital,
11,12 Thube Park,
16,Shivajinagar,
Pune
411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9850738571 |
| Fax |
912025530333 |
| Email |
mmdadke@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhuri Dadke |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti hospital |
| Address |
Department of Anaesthesia
Sancheti you hospital
First floor Sior Ot
11,12 Thube Park,
16,Shivajinagar,
Pune
411005
Department of Anaesthesia
Sancheti hospital
First floor Sior OT
11,12 Thube Park,
16,Shivajinagar,
Pune
411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9850738571 |
| Fax |
912025530333 |
| Email |
mmdadke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhuri Dadke |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Sancheti hospital |
| Address |
Department of Anaesthesia
Sancheti hospital
First floor Sior OT
11,12 Thube Park,
16,Shivajinagar,
Pune
Department of Anaesthesia
Sancheti hospital
First floor Sior OT
11,12 Thube Park,
16,Shivajinagar,
Pune
411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9850738571 |
| Fax |
912025530333 |
| Email |
mmdadke@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sancheti Hospital |
| Address |
11/12 Thube Park ,
16, Shivajinagar, Pune, Maharashtra 411005 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Madhuri Dadke |
Sancheti Hospital |
Department of Anaesthesia ,
First floor Sior OT
11/12 Thube Park 16, Shivajinagar, Pune, Maharashtra 411005
Pune
MAHARASHTRA |
9850738571
mmdadke@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Sancheti hospital |
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 |
Ultrasound guided Interscalene block for arthroscopic shoulder cuff repair |
Ultrasound guided Interscalene block will be performed on the side of surgery after anaesthesia is induced |
| Intervention |
Ultrasound guided Suprascapular block with infraclavicular block for arthroscopic shoulder cuff repair |
Ultrasound guided Suprascapular and infraclavicular block will be performed on the side of surgery after anaesthesia is induced |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Pts consenting to procedure and willing to participate,
Patients of ASA grades 1 to 3 |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Patients with bleeding disorders or on anticoagulant
Previous surgery at site of block
SUG or alcohol abuser’s
Pts allergic to local anaesthetic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare analgesic efficacy of ultrasound guided interscalene block versus Suprascapular with infraclavicular block |
Baseline ,at 4 hrs,8 hrs ,16 hrs and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare pain scores,hemodynamics,postoperative motor blockade,and complications in both groups
Diaphragmatic palsy |
24hrs |
|
|
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)
|
15/12/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will be recruiting 60 ASA grade 1 to 3 patients age group 18 to 75 years in each group .Patients with shoulder cuff injuries for arthroscopic cuff repairs and willing to participate will be included.Patients with severe cardiac,pulmonary,renal,hepatic diseases ,allergic to local anaesthesic drugs ,pregnant patients,and coagulopathies and emergency patients will be excluded.Patients refusing to participate or not able to give consent will be excluded. All patients will receive standardised general anaesthesia followed by the block as per randomisation. Group 1 will receive ultrasound guided interscalene block 12 ml of 0.2 %Ropivacaine with 30 micrograms of clonidine. Group 2 will receive ultrasound guided Suprascapular block 5 ml and infraclavicular block 10 ml of 0.2%Ropivacaine with 30 micrograms of clonidine . Patients will be monitored postoperative VAS NRS score,PONV at regular intervals, IV Paracetamol will be used for breakthrough pain if NRS is more than 4 .A 24 hour Fentanyl consumption will be compared in both groups which will be primary outcome.Secondary outcomes will be comparison of VAS scores ,hemodynamics and PONV. Complications related to block performance (LAST),blood on aspiration will be noted and compared. With the help of biostatistician the collected data will be analysed. Consent procedure:consent will be taken in the language best understood by the patient and will include the description of the purpose of the study ,the protocol involved,risks and benefits and the choice of exiting the study at any point of time.
|