| CTRI Number |
CTRI/2026/03/106032 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to see if adding dexmedetomidine to the anesthetic used for a shoulder nerve block provides longer and better pain relief after shoulder surgery. |
|
Scientific Title of Study
|
Efficacy of low dose dexmedetomidine as a perineural adjunct to ropivacaine for single shot interscalene brachial plexus block in arthroscopic shoulder surgery - A prospective randomized controlled study. |
| 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 NAGIPOGU PRIYANKA |
| Designation |
Junior Resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room no 2 , MOT , 1st floor, Department of Anesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9618560718 |
| Fax |
|
| Email |
priyankaoji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narmada Padhy |
| Designation |
Professor |
| Affiliation |
Nizams Institute of medical sciences |
| Address |
Room no 1, 1st floor, IDOT, Department of Anesthesia, Outpatient building, Nizams institute of medical sciences, Punjagutta, Hyderabad 500082, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9392408465 |
| Fax |
|
| Email |
narmadapadhy1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAGIPOGU PRIYANKA |
| Designation |
Junior Resident |
| Affiliation |
Nizams institute of medical sciences |
| Address |
Room no 2 , MOT , 1st floor, Department of Anesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, India
Hyderabad
TELANGANA
500082
India |
| Phone |
9618560718 |
| Fax |
|
| Email |
priyankaoji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, India |
|
|
Primary Sponsor
|
| Name |
NAGIPOGU PRIYANKA |
| Address |
Room no 2 , MOT , 1st floor, Department of Anesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, India |
| 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 NAGIPOGU PRIYANKA |
Nizams Institute of Medical Sciences |
Room no 2 , MOT , 1st floor, Department of Anesthesia, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad 500082, India
Hyderabad
TELANGANA |
9618560718
priyankaoji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group : Ropivacaine |
Preoperatively, patients receive 0.2%ropivacaine in ultrasound guided single shot interscalene brachial plexus block
Block duration is around 10 to 20 mins |
| Intervention |
Interventional Group : Ropivacaine with Dexmedetomidine |
Preoperatively, patients receive 0.2% ropivacaine along with dexmedetomidine 0.5mcg/kg in ultrasound guided single shot interscalene brachial plexus block.
Block duration is around 10-20 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria :
1.Patients aged 18-60 years
2.Undergoing elective shoulder arthroscopic surgery under general anesthesia.
3. American Society of anesthesiologists(ASA) physical status, classification I or II, indicating those with no systemic disease or mild systemic disease.
4.Ability to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1.History of allergy or hypersensitivity to dexmedetomidine.
2. Patients on antihypertensives such as methyldopa, clonidine, and other alpha2 agonists
3. Having BMI more than 30kg/m², peripheral neuropathy, coagulopathies, uncontrolled diabetes, liver and kidney dysfunctions
4. Participating in other clinical trials currently.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary objective is to measure the duration of analgesia |
T1 Before giving Block (R/DR)
T2 After giving Block(R/DR)
T5 5 min after block
T10 10 min after block
T15 15 min after block
T20 20 min after block
T25 25 min after block
T30 30 min after block
T45 45 min after block
T60 60 min after block
T90 90 min after block
TE END OF SURGERY
TP1 1 hr post surgery
TP2 2 hr post surgery
TP3 3 hr post surgery
TP4 4 hr post surgery
TP6 6 hr post surgery
TP8 8 hr post surgery
TP10 10 hr post surgery
TP12 12 hr post surgery
TP24 24 hr post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective:
a)To assess VAS (Visual Analog Scale) pain score.
b) To monitor total intraoperative fentanyl requirement and postoperative tramadol requirement.
c) To assess patient satisfaction (Likert scale).
d) To monitor hemodynamic variables and complications if any.
|
T1 Before giving Block (R/DR)
T2 After giving Block(R/DR)
T5 5 min after block
T10 10 min after block
T15 15 min after block
T20 20 min after block
T25 25 min after block
T30 30 min after block
T45 45 min after block
T60 60 min after block
T90 90 min after block
TE END OF SURGERY
TP1 1 hr post surgery
TP2 2 hr post surgery
TP3 3 hr post surgery
TP4 4 hr post surgery
TP6 6 hr post surgery
TP8 8 hr post surgery
TP10 10 hr post surgery
TP12 12 hr post surgery
TP24 24 hr post surgery
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="0"
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
|
Arthroscopic shoulder surgery is commonly associated with significant postoperative pain, which can affect early recovery and patient comfort. The interscalene brachial plexus block is considered the gold standard regional anesthesia technique for providing perioperative analgesia in shoulder surgeries. Ropivacaine is widely used for this block because of its long duration of action and favorable safety profile. However, the duration of analgesia with local anesthetics alone may be limited, leading to the need for additional postoperative analgesics. Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has been increasingly used as an adjuvant to local anesthetics in peripheral nerve blocks. When administered perineurally, dexmedetomidine may prolong the duration of sensory and motor blockade, enhance the quality of analgesia, and reduce postoperative analgesic requirements. This prospective randomized controlled study aims to evaluate the efficacy of low-dose dexmedetomidine as a perineural adjunct to ropivacaine in single-shot interscalene brachial plexus block for patients undergoing arthroscopic shoulder surgery. The study will assess block characteristics, duration of postoperative analgesia, time to first rescue analgesic, total analgesic consumption, and incidence of adverse effects.
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