| CTRI Number |
CTRI/2026/04/107592 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
02/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs (Dexmedetomidine and Fentanyl) added to local anaesthesia for pain relief in shoulder surgeries |
|
Scientific Title of Study
|
To compare the effect of dexmeditomedine and fentanyl as an adjuvant to bupivacaine in peripheral nerve stimulator guided interscalene brachial plexus block in shoulder surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avani Pareek |
| Designation |
Junior Resident |
| Affiliation |
Dutta Meghe Institute of Medical and Research |
| Address |
Dutta Meghe Institute of Medical Sciences and Research
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7247596569 |
| Fax |
|
| Email |
avanipareek@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Dutta Meghe Institute of Medical Sciences and Research |
| Address |
Dutta Meghe Institute of Medical Sciences and Research
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karuna Taksande |
| Designation |
Professor |
| Affiliation |
Dutta Meghe Institute of Medical Sciences and Research |
| Address |
Dutta Meghe Institute of Medical Sciences and Research
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College,Sawangi Meghe,Wardha,Maharashtra,442001 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
Sawangi Meghe, Wardha, Maharashtra, 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Avani pareek |
Acharya Vinoba Bhave Rural Hospital |
Department of Anesthesia,
Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital,
Datta Meghe Institute of Higher Education and Research (Deemed to be University),
Sawangi (Meghe), Wardha,
Maharashtra – 442107,
India.
Wardha
MAHARASHTRA |
7247596569
avanipareek@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S422||Fracture of upper end of humerus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmeditomedine |
Dexmeditomedine ia a highly selective alpha2 adrenergic receptor agonist having 8 times more affinity compared to alpha1, it is used as an adjuvant to local aesthetic and found increase the duration of block
Dexmedetomidine 50 mcg (0.5 ml) added to 20 ml of 0.5% bupivacaine, administered as a single-shot perineural injection via peripheral nerve stimulator-guided interscalene brachial plexus block.
Route: Perineural
Frequency: Single dose
Total duration of intervention: Single administration intraoperatively (block performed once prior to surgery). |
| Comparator Agent |
Fentanyl |
Fentanyl is an opioid that has shown to enhance the analgesic potency of bupivacaine for nerve block, it prolongs the duration of analgesia in early postoperative period
Fentanyl 50 mcg (1 ml) added to 20 ml of 0.5% bupivacaine, administered as a single-shot perineural injection via peripheral nerve stimulator-guided interscalene brachial plexus block.
Route: Perineural
Frequency: Single dose
Total duration of intervention: Single administration intraoperatively (block performed once prior to surgery). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2
Patient undergoing elective shoulder surgeries
Duration of surgery 120-180 minutes |
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to local anaesthetic and opioids
Local infection at the site of block
Pregnant women
Severe cardiopulmonary disease
Patient with neurological deficit in operating arm |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the effect of dexmeditomidine and fentanyl used as an adjuvant to bupivacaine in post operative analgesia given as inter scalene brachial plexus block in shoulder surgeries |
6 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time of onset of secondary blockade
duration of secondary blockade
time of onset of motor blockade
duration of onset of motor blockade
incidence of side effects |
6 hours |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2026 |
| 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 Yet Recruiting |
| 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 study aims to compare the efficacy of dexmedetomidine and fentanyl as adjuvants to bupivacaine in peripheral nerve stimulator-guided interscalene brachial plexus block in patients undergoing elective shoulder surgeries. A total of 50 patients will be randomly allocated into two groups to receive either dexmedetomidine or fentanyl along with bupivacaine. The study will evaluate onset and duration of sensory and motor block, duration of postoperative analgesia, hemodynamic parameters, and any adverse effects. The objective is to determine which adjuvant provides better analgesia and block characteristics with minimal side effects. |