| CTRI Number |
CTRI/2018/05/013671 [Registered on: 03/05/2018] Trial Registered Prospectively |
| Last Modified On: |
27/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study for postoperative pain relief using two drugs in combination in patients undergoing arthroscopic shoulder surgery. |
|
Scientific Title of Study
|
Postoperative pain relief in arthroscopic shoulder surgery with ultrasound guided interscalene block with ropivacaine and fentanyl combination using two techniques- A prospective randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishav Monga |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital Sector-32 Chandigarh |
| Address |
A-201,Royale Mansion Society,Peer Muchalla,Zirakpur
Chandigarh
CHANDIGARH
140603
India |
| Phone |
9779118486 |
| Fax |
|
| Email |
monga.vishav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Sector-32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital Sector-32 Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Sukanya Mitra |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Sector-32 Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital Sector-32 Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121521 |
| Fax |
|
| Email |
drsmitra12@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector-32 Chandigarh State Chandigarh Pin 160031 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia and Intensive Care |
| Address |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector-32 Chandigarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Orthopaedics |
Department of Orthopaedics Government Medical College and Hospital Sector-32 Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishav Monga |
Government Medical College and Hospital Sector-32 Chandigarh |
Elective Orthopaedics Operation Theatre Section, 3rd floor, C Block, Government Medical College and Hospital Sector-32 Chandigarh
Chandigarh
CHANDIGARH |
9779118486
monga.vishav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE,GMCH,CHANDIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients fit for shoulder surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
injection dexamethasone injection ropivacaine, injection fentanyl |
Patients will receive a single shot of intravenous injection dexamethasone 8 mg and perineural continuous infusion of 0.2% ropivacaine and 2 mcg /ml fentanyl at the rate of 5ml/h with patient controlled boluses(PCA) of 5ml with a lockout interval of 30 min for a period of two days. |
| Intervention |
injection dexamethasone,injection ropivacaine, injection fentanyl |
Patients will receive a single shot of intravenous injection dexamethasone 8 mg and perineural patient controlled boluses of 5ml of 0.2% ropivacaine with 2 mcg/ml fentanyl with a lock out interval of 30 min for a period of two days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists (ASA)
physical status I-II
BMI – 18-30 kg/m2
Undergoing Arthroscopic shoulder surgery such
as rotator cuff injury repair, recurrent
shoulder dislocations, superior labrum
anterior and posterior (SLAP lesion),
acromioplasty, labral cyst removal.
|
|
| ExclusionCriteria |
| Details |
Patient refusing to give informed consent
History of relevant drug allergy
History of psychiatric illness, substance
abuse
Severe cardiovascular, respiratory, metabolic
or neurological disease
Pregnancy and lactation
Coagulopathy
Contralateral phrenic nerve dysfunction
Infection at planned injection site
Patients on steroids
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean postoperative pain score measured by numeric rating scale(NRS) over 48h study period. |
Mean NRS pain score between the two groups over 48h study period at time intervals of 1,4,12,24,36,48h. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Difference in total analgesic consumption, rescue analgesic use, manual muscle test scoring, patient satisfaction and adverse effects if any.
|
Difference in total analgesic consumption, rescue analgesic use, manual muscle test scoring, patient satisfaction and adverse effects if any checked at intervals of 1,4,12,24,36,48 hour time period.
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/09/2018 |
| 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="2"
Days="3" |
|
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)?
|
|
Brief Summary
|
Regional anaesthesia has proven to be a highly effective technique for pain relief in patients undergoing total shoulder arthroplasty. Continuous Interscalene block for orthopaedic surgery may be used as either the primary anaesthetic or as an adjunct to general anaesthesia. Shoulder surgeries are associated with substantial pain which may be exacerbated by shoulder movement on physiotherapy employed for postoperative rehabilitation and optimal surgical outcome. The benefit of effective continuous interscalene block include reductions in opoid requirements, reduced requirement for systemic analgesics, decrease postoperative nausea and vomiting, decreased time to functional recovery alongwith reduction in postoperative pain for prolonged period. So in this study we plan to compare the efficacy of ropivacaine (0.2%) and fentanyl (2 micrograms/ml) when used as perineural boluses of local anaesthetic delivered as on demand with continuous perineural infusion in interscalene block against only patient controlled boluses, along with intravenous dexamethasone (8 mg) as an adjunct in both groups after arthroscopic shoulder surgery. |