| CTRI Number |
CTRI/2025/09/095269 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [Randomised controlled trial] |
| Study Design |
Other |
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Public Title of Study
|
Comparing combination of two drugs namely 0.25 percent Ropivacaine and Dexmedetomidine when used with Clonidine in nerve blocks to compare pain relief in patients aged 18 to 64 yrs who are posted for shoulder arthroscopic surgeries
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Scientific Title of Study
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Comparison of 0.25 percent Ropivacaine with Dexmedetomidine vs Clonidine as an adjuvant in Interscalene Brachial plexus block for post operative analgesia in shoulder arthroscopy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandra Monis |
| Designation |
Post graduate |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
7022474598 |
| Fax |
|
| Email |
sandramonis9@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nischala Dixit |
| Designation |
Professor Department of Anaesthesia St. Johns Medical College Hospital |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
9535148078 |
| Fax |
|
| Email |
drnischala01@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sandra Monis |
| Designation |
Post graduate |
| Affiliation |
St. Johns Medical College and Hospital, Bangalore |
| Address |
Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Department of Anesthesiology St. Johns Medical College and Hospital Sarjapura Road Koramangala Bengaluru-560034 Bangalore KARNATAKA 560034 India |
| Phone |
7022474598 |
| Fax |
|
| Email |
sandramonis9@gmail.com |
|
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Source of Monetary or Material Support
|
| Department of Anesthesia and Critical Care St. Johns Medical College and Hospital, Bengaluru-560034 |
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Primary Sponsor
|
| Name |
ST JOHNS MEDICAL COLLEGE AND HOSPITAL |
| Address |
OT Complex, 2nd floor, St. Johns Medical and Hospital, Sarjapur-Marathahalli Rd,beside Bank of Baroda, John Nagar, Koramangala Bengaluru-560034 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandra Monis |
St. Johns Medical College and Hospital |
OT Complex, 2nd floor St. Johns Medical College and Hospital Sarjapura road Koramangala Bengaluru-560034 Bangalore KARNATAKA |
7022474598
sandramonis9@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, St. Johns Medical College and Hospital |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 - Inj 0.25 % Ropivacaine + Clonidine |
Patients randomised into group 1 will receive an interscalene brachial plexus block with 0.25 percent Ropivacaine plus Clonidine. |
| Comparator Agent |
Group 2 - Inj 0.25 % Ropivacaine + Dexmedetomidine |
Patients randomised into group 2 will receive an interscalene brachial plexus block with 0.25 percent Ropivacaine plus Dexmedetomidine. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group- 18 - 59years,
2) Scheduled for elective shoulder arthroscopic surgeries under GA
3) ASA Grade I and II patients
|
|
| ExclusionCriteria |
| Details |
1) Patient refusal
2) Bleeding disorders
3) Patients with known local anesthetic sensitivity
4) morbidly obese patients
5) Previous h/o upper limb nerve damage
6) Respiratory insufficiency
7) Infection at the block location.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of 12 ml of 0.25% Ropivacaine + Dexmedetomidine vs 12 ml of 0.25% Ropivacaine + Clonidine on duration of analgesia when used in Interscalene Brachial Plexus block for shoulder arthroscopy. |
Postoperatively VAS scores of patients will be assessed for 2,4,6,8,10,12,24 hrs |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1)VAS Score over 24 hours
2)Time to first request of post operative analgesia
3)Total IV PCA Fentanyl consumption over 24 hrs
|
Vas score will be assessed at 2,4,6,8,10,12,24 hrs post block |
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Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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 4 |
|
Date of First Enrollment (India)
|
06/10/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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Introduction
Arthroscopy is one of the greatest advancements
in the field of orthopaedic surgery. The advent of such a minimal invasive
procedure made away with the need for standard open surgical techniques
resulting in a decrease in post op complications thereby facilitating faster
recovery. Shoulder Arthroscopy, the second most performed orthopaedic procedure
is now employed to treat a myriad of pathologies like labral tears, rotator
cuff tears, adhesive capsulitis, subacromial impingement, degenerative
arthritis, proximal biceps pathology, loose bodies etc. It also offers a
comprehensive view of intraarticular pathologies if any. A study on
patient perception of shoulder arthroscopy vs open techniques showed that a
vast majority of patients perceived the former to be superior to open surgery
in terms of functional outcome. However, shoulder arthroscopic surgeries
are reputed to produce intense post operative pain. This is usually
circumvented by administering blocks like Inter scalene block which is reported
to deliver excellent post-operative analgesia. It is a type of regional
anaesthesia that targets the Brachial Plexus, a complex network of nerves
originating from the cervical spine, and is performed with local anaesthetics,
the choice of which is determined by the magnitude and duration of surgery.
Long-acting drugs such as Ropivacaine or Levobupivacaine are usually employed
for most surgeries. The block can be further enhanced by using adjuvants
like Adrenaline, Soda bicarbonate, Clonidine, Buprenorphine, Dexamethasone and
Dexmedetomidine.
Dexmedetomidine is a highly selective a2-adrenergic agonist that
inhibits Norepinephrine release, leading to enhanced analgesia and sedation.
Compared to clonidine, it provides a more potent and controlled sedation, along
with a faster onset of action. Clonidine, which also functions as an
a2-adrenergic agonist shares a similar mechanism of action but has a more
prolonged duration of action. However, its sedative and analgesic effects tend
to be less pronounced than those of Dexmedetomidine.
Methodology · The
study will be non blinded and will be conducted after obtaining approval from
the Institutional Ethics Committee (IEC) and written informed consent of
patients.
·
42 patients of ASA
grades 1 and 2 aged between 18-59 years of age undergoing shoulder arthroscopic
surgeries will be included in this study and will be divided into two
groups by simple randomisation
in a 1:1ratio based on a computer-generated sequence - Group 1 and Group 2.
· Detailed
Pre- anaesthetic evaluation and relevant investigations will be done for each
patient following which written informed consent will be taken.
· The
patients will be kept Nil per oral- 6 hours for solids and 2 hours for clear
liquids.
·
In the operation
theatre Standard monitors including electrocardiography (ECG), non-invasive
blood pressure (NIBP) and pulse oximetry (SPO2) will be connected and vitals
will be monitored.
·
Patients will be preoxygenated with 100%
oxygen for 3 min, followed by induction with Propofol 2 mg/kg intravenously and
Atracurium 0.5 mg/kg to facilitate endo tracheal intubation. Patient will be
maintained on general anaesthesia with Isoflurane/O2/air mixture
With a MAC value of 1.2. Muscle relaxation will be provided by intermittent
boluses of Atracurium.
· Following
intubation, the patient’s head will be turned 30
degrees away from the side to be blocked and ipsilateral arm will be
kept in adducted position. Supraclavicular fossa and surrounding area will be
painted in circular motions and draped.
· The
block will be performed by a
practitioner who has given a minimum of 20 USG guided supraclavicular blocks in
the past.
· Linear
USG probe will be applied in supraclavicular fossa to visualize the brachial
plexus posterolateral to the subclavian artery
· Local
infiltration at site of needle entry with 1 mL of 2% Lignocaine.
·
In both the groups, local
anaesthetic drug used will be a mixture of 12ml of 0.25% Ropivacaine
.
Group
1 (Clonidine) – Clonidine (1mcg/kg) + 12 ml of Inj 0.25 % Ropivacaine
Group
2 (Dexmed)- Dexmedetomidine (1mcg/kg) +12 ml of Inj 0.25 % Ropivacaine
The
primary outcome of this study is duration of analgesia which will be assessed
as the time interval between extubation and the patient’s first request for
pain relief: VAS scores will be measured at 2, 4, 6, 8, 10, 12 and 24 hours postoperatively.
When post op VAS score>6, Inj. Fentanyl will be given as a rescue analgesic.
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