| CTRI Number |
CTRI/2025/02/081136 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the Effects of Adding Dexmedetomidine to Bupivacaine versus Using Bupivacaine Alone in Nerve Blocks for Shoulder Surgery |
|
Scientific Title of Study
|
Comparative study to evaluate the effect of dexmeditomedine as adjuvant to 0.5% bupivacaine with 0.5% plain bupivcaine under USG guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anaesthesia. |
| 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 Meenal Rajput |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Second Floor, SMSC Building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8305044403 |
| Fax |
|
| Email |
drminals10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Taksande |
| Designation |
Professor , Dept. of Anesthesia |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Second Floor, SMSC Building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karuna Taksande |
| Designation |
Professor , Dept. of Anesthesia |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Second Floor, SMSC Building Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
7722037738 |
| Fax |
|
| Email |
karunahp1878@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India-442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Wardha, Maharashtra, India-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 |
| Dr Meenal Rajput |
Jawaharlal Nehru Medical College |
Department of
Anaesthesiology
Shalinitai Meghe
Superspeciality Hospital
AVBRH campus
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
8305044403
drminals10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe Institute of Higher Education and Research 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 |
0.5% plain bupivacaine |
Effect of post-operative analgesia achieved with 0.5% plain bupivacaine will be assessed in ultrasound-guided interscalene brachial plexus block for shoulder arthroscopy under general anaesthesia. Route of administration: -interscalene brachial plexus block Dose administration: -20 ml 0.5% plain bupivacaine Duration: Post operative 0 hr to 6 hrs |
| Intervention |
Dexmeditomedine as adjuvant to 0.5% bupivacaine |
Effect of Dexmedetomidine as adjuvant to 0.5% bupivacaine will be assessed for post-operative analgesia in patients of interscalene brachial plexus block for patient undergoing ultrasound-guided shoulder arthroscopy under general anesthesia. Route of administration: -Interscalene brachial plexus block Dose administration: - 0.2 ml Dexmedetomidine and 20 ml,0.5% bupivacaine Duration: Post operative 0 hr to 6 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with ASA physical status I & II will be considered for inclusion.
2.Patients who are scheduled to undergo elective shoulder arthroscopy will be eligible.
3.Individuals aged between 18 and 65 years old will be included in the study.
4.Patients who express a willingness to actively participate in the study will be considered for enrollment. |
|
| ExclusionCriteria |
| Details |
1.Patients who refuse to participate will be excluded from the study.
2.Individuals with known allergies to local anesthetics and opioids will not be included.
3.Patients with a local infection at the site of the intended block will be excluded.
4.Pregnant women will not be eligible for participation.
5.Individuals with severe cardiopulmonary diseases will be excluded from the study.
6.Patients with neurological deficits in the arm selected for surgery will not be considered.
7.Individuals with bleeding disorders or those currently on anticoagulant medications will be excluded from participation. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of post-operative analgesia with dexmeditomedine as adjuvant to 0.5% bupivacaine will be significantly more as compared to 0.5% plain bupivcaine. |
Assessments will be done at 30 min, 1 hour, 2, 3,4,5 and 6 hours. Study will be conducted over a period of 2 years. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative Hemodynamic stability and Side Effects
|
Intraoperative Hemodynamic stability will be assessed at 5mins, 15 mins, 30 mins , 1 hr and 2 hrs.
2. evaluation of the occurrence of any adverse effects.
|
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2025 |
| 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 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 protocol aims to evaluate the effect of dexmeditomedine as adjuvant to 0.5% bupivacaine and 0.5% plain bupivacaine under usg guided interscalene brachial plexus block (ISBPB) for patient undergoing shoulder arthroscopy under general anesthesia. The primary objective is to assess the postoperative analgesia with dexmeditomedine as adjuvant to 0.5% bupivacaine with 0.5% plain bupivacaine under usg guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anesthesia. Secondary objectives include to evaluate the Intraoperative Hemodynamic stability and Side effects (if any). The study will be conducted at Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital in Sawangi, Wardha, over a 2-year period. The study design is Prospective Randomized Interventional Study, and the source of data will be patients aged 18 to 65 years undergoing under usg guided interscalene brachial plexus block for patient undergoing shoulder arthroscopy under general anesthesia. A total of 60 patients will be included, with 30 in each group. Patients meeting the inclusion criteria will be alternative randomly allocated into one of those two groups (Group B & Group BD of patients in each group and both groups will receive equal volume of drug (0.5% Bupivacaine 20ml + 0.2 ml adjuvant, so total of 20.2 ml). Outcome measures include the postoperative analesgia, Intraoperative Hemodynamic stability and Side effects as well as pain scores assessed using a visual analogue scale. Postoperative pain was measured for first 6 hours using the visual analog scale (VAS). Data will be analyzed using appropriate statistical tests, and ethical considerations will be followed throughout the study. The results of this study are expected to provide insights into the potential benefits of dexmedetomidine as an adjuvant in peripheral nerve blocks for shoulder arthroscopy, contributing to enhanced postoperative pain management strategies and patient outcomes. |