| CTRI Number |
CTRI/2025/04/084341 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Preoperative Neck Nerve Block on Pain Relief and Anesthesia Use in patients undergoing Upper Arm Surgery |
|
Scientific Title of Study
|
Effect of preoperative Interscalene block on intraoperative anaesthetic requirements in patients undergoing upperarm surgeries 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 Nithya |
| Designation |
PG student |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
BMCRI
Dept of Anaesthesiology
BANGALORE -560002
KARNATAKA
INDIA
BMCRI
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
09500175571 |
| Fax |
|
| Email |
nithyarajagopal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudheesh K |
| Designation |
Professor |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
BMCRI
Dept of Anaesthesiology
BANGALORE -560002
KARNATAKA
INDIA
BMCRI
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
9900134694 |
| Fax |
|
| Email |
dr.sudhi77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithya |
| Designation |
PG student |
| Affiliation |
BANGALORE MEDICAL COLLEGE AND HOSPITAL |
| Address |
BMCRI
Dept of Anaesthesiology
BANGALORE -560002
KARNATAKA
INDIA
BMCRI
BANGALORE
Bangalore
KARNATAKA
560002
India |
| Phone |
09500175571 |
| Fax |
|
| Email |
nithyarajagopal1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE,BANGALORE,KARNATAKA 560002 |
|
|
Primary Sponsor
|
| Name |
VICTORIA HOSPITAL |
| Address |
BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
BANGALORE
KARNATAKA-560002
INDIA |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nithya |
VICTORIA HOSPITAL |
BANGALORE
KARNATAKA 560002
INDIA
Bangalore
KARNATAKA |
9500175571
nithyarajagopal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M218||Other specified acquired deformities of limbs, (2) ICD-10 Condition: M244||Recurrent dislocation of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GA alone |
PROPOFOL,FENTANYL,DEXAMETHASONE,ATRACURIUM,VECURONIUM,NEOSTIGMINE AND GLYCOPYROLATE
duration 1-3hrs |
| Intervention |
Preoperative interscalene block +GA |
INJ.BUPIVACAINE,PROPOFOL,FENTANYL,DEXAMETHASONE,ATRACURIUM,VECURONIUM,NEOSTIGMINE AND GLYCOPYROLATE
duration-1-3 hrs |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients ( 18- 65 yrs) of both genders are included after receiving informed written consent ( Annexure 1)
2.Patients belonging to American Society of Anesthesiologist Class 1-2 (Annexure 3)
3.Patients undergoing upper limb surgeries under General anaesthesia.
|
|
| ExclusionCriteria |
| Details |
1. Uncooperative patients
2. Patients with obstructive pulmonary disease,Diabetes,Neuropathy, brachial plexus and radial nerve injury, Contralateral diaphragmatic paralysis, chest wall and lung injury, history of allergy to study drug
3. Patients having contraindications for Interscalene block
4. Patients on antiepileptics,psychotropic drugs,long term analgesics.
|
|
|
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 |
compare the changes in heart rate,systolic blood pressure and Diastolic blood pressure at before
,during and after cannulation
Compare the VAS score anong the two groups
compare the ease of cannulation between two groups. |
Baseline
Preinduction
Post induction
Post Intubation
5min
10 min
15 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
55 min
60 min
65 min
70 min
75 min
80 min
85 min
90 min
95 min
100 min
105 min
110 min
115 min
120 min
125 min
130 min
140 min
150 min
160 min
170 min
180 min
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare the ease of cannulation between two groups. |
aseline
Preinduction
Post induction
Post Intubation
5min
10 min
15 min
20 min
25 min
30 min
35 min
40 min
45 min
50 min
55 min
60 min
65 min
70 min
75 min
80 min
85 min
90 min
95 min
100 min
105 min
110 min
115 min
120 min
125 min
130 min
140 min
150 min
160 min
170 min
180 min
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="46"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
18/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
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
|
Interscalene nerve block (ISB) has been commonly used as a sole anaesthetic technique and also alleviate postoperative pain and provide optimal analgesia during shoulder and upper arm surgeries. Ultrasound-guided interscalene nerve block (UISB) can reduce opioid use and its concomitant opioid-related adverse effects such as pruritus, nausea, vomiting, consciousness disturbance, and constipation. However, these trials focused mainly on the postoperative opioid-sparing effects of nerve blocks and did not show an impact on the intraoperative consumption of volatile anesthetics and opioids . Desflurane is a newer inhalational anaesthetic with minimal metabolism in the human body, and is associated with rapid recovery.Opioid consumption was reduced using a single ISB at the day of surgery They found that ISB is superior to GA and GA + ISB in patients undergoing shoulder arthroscopy in terms of faster recovery and analgesics consumption. |