CTRI Number |
CTRI/2023/06/054070 [Registered on: 19/06/2023] Trial Registered Prospectively |
Last Modified On: |
17/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
|
A comparative study of Dexamethasone by two different routes as an adjuvant to Ropivacaine in USG guided supraclavicular block for upper limb surgeries |
Scientific Title of Study
|
To compare the analgesic efficacy of perineural and intravenous Dexamethasone as an adjuvant to 0.5% Ropivacaine for ultrasound guided brachial plexus block for upper limb surgeries: A randomised, triple blind placebo controlled trial. |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
ANIL KUMAR |
Designation |
JUNIOR RESIDENT |
Affiliation |
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA |
Address |
DEPARTMENT OF ANAESTHESIOLOGY
DR RAJENDRA PRASAD GOVERNMENT
MEDICAL COLLEGE TANDA KANGRA H.P 176001
Kangra HIMACHAL PRADESH 176001 India |
Phone |
8580857471 |
Fax |
|
Email |
anilsohal199@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr SHYAM BHANDARI |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA AT KANGRA |
Address |
DEPARTMENT OF ANESTHESIOLOGY
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9805135129 |
Fax |
|
Email |
dr.bhandari@yahoo.Co.in |
|
Details of Contact Person Public Query
|
Name |
DR SHYAM BHANDARI |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA |
Address |
DEPARTMENT OF ANESTHESIOLOGY
DR RAJENNDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA AT KANGRA TANDA
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9805135129 |
Fax |
|
Email |
dr.bhandari@yahoo.Co.in |
|
Source of Monetary or Material Support
|
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA AT KANGRA |
|
Primary Sponsor
|
Name |
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA |
Address |
DEPARTMENT OF ANESTHESIOLOGY
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE TANDA AT KANGRA PIN CODE 176001 |
Type of Sponsor |
Government 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 ANIL KUMAR |
DR RAJENDRA PRASAD GOVERNMENT MEDICAL COLLEGE KANGRA AT TANDA |
DEPARTMENT OF ANESTHESIOLOGY
DR RAJENDRA PRASAD MEDICAL COLLEGE KANGRA AT TANDA PIN CODE 176001 Kangra HIMACHAL PRADESH |
8580857471
anilsohal199@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
DR RAJENDRA PRASAD GOVT MEDICAL COLLEGE TANDA AT KANGRAia-176001 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S423||Fracture of shaft of humerus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
to compare analgesic efficacy of perineural vs intravenous dexamethasone in prolonging analgesia in ultrasound guided supraclavicular block |
Group A includes 25 patients. We will give 19ml of 0.5% Ropivacaine with 1ml of 4mg Dexamethasone perineurally and 1ml iv Normal saline. |
Intervention |
to compare analgesic efficacy of perineural vs intravenous dexamethasone in prolonging analgesia in ultrasound guided supraclavicular block |
Group C includes 25 patients and will receive 19ml of 0.5% Ropivacaine with 1ml NS perineurally and 1ml normal saline i.v. as placebo. |
Intervention |
To compare analgesic efficacy of perineural vs intravenous dexamethasone in prolonging analgesia in ultrasound guided supraclavicular block in patients. |
Group B includes 25 patients and will receive 19 ml of 0.5% of Ropivacaine and 1ml Normal saline perineurally with 1ml of 4mg Dexamethasone i.v. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Males and females between the age
group18-65 years.
2.ASA class I-II.
3.BMI 18.5-29.9.
4.Undergoing surgeries around mid-arm,
elbow, forearm and hand. |
|
ExclusionCriteria |
Details |
1.Patient’s refusal for block.
2.History of cardiac, renal or hepatic
disease, CNS disorders, neuropathy.
3.Patients having bleeding disorders.
4. Hypersensitivity to local anaesthetics
and study drugs.
5.Local infection at the site where needle
for block is to be inserted.
6.Patients in whom the block effect will
be partial and will require
supplementary anaesthesia. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Time of first analgesic request. |
Time of first analgesic request after successful supraclavicular block.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
The secondary outcome measure include the number of supplemental analgesic requirements, VAS pain, patient satisfaction, random blood sugar. |
Postoperatively the patients will be evaluated for pain at 4,6,12,18,24 hours with visual analog scale pain score. Sensory & motor blockade will be assessed every 2 min for first 20 mins, then every 5 mins till 40 mins, then every 15 mins till end of surgery & thereafter every 30 mins till recovery of sensory & motor block. Random blood sugar will be monitored every 4 hourly in post-operative period for 24 hrs. following Dexamethasone injection.
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
25/06/2023 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Not yet started |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Supraclavicular brachial plexus block is considered to be one of the most effective approach for anesthesia for upper limb surgery. The brachial plexus is most compact at the level of the trunks formed by the C5–T1 nerve roots, so nerve block at this level has the greatest likelihood of blocking all of the branches of the brachial plexus. The compactness of the brachial plexus in this location facilitates a rapid onset and complete block of the brachial plexus for procedures distal to the shoulder. Ultrasound guided supraclavicular brachial plexus block has improved the success rate of block with excellent localization as well as improved safety margin. The supraclavicular block is ideal for operations involving the arm and forearm.
Various local anesthetics like Ropivacaine, Bupivacaine etc ,have been used with safety and efficacy in performing such blocks. Local anesthetics act on the voltage-gated sodium channels that conduct electrical impulses and mediate fast depolarization along nerves. they target open channels and prevent ion flow. This act on potassium channels, but they block sodium channels more. They preferentially binds to the inactivated state of voltage gated sodium channels, but has also been found to bind potassium channels, G-protein coupled receptors, NMDA receptors, and calcium channels in vitro. Adjuvants are those drugs which, when co-administered with local anesthetic agents, may improve the speed of onset and duration of analgesia and counteract disadvantageous effects of local anesthetics. By adding these adjuvants, the dose of local anesthetics can be reduced, thereby reducing its side effects like myocardial depression, hypotension, bradycardia, heart block, and ventricular arrhythmias. Various adjuvants has been introduced with these agents to prolong the duration of blockade in long surgeries. Some of the additives used with local anesthetics include alpha2 agonists, NSAIDS, opioids, and glucocorticoids. Addition of long acting glucocorticoids like Methylprednisolone with local anesthetics have been used to treat chronic pain. Latest to this series is Dexamethasone which not only prolongs the analgesia but also decreases the local inflammation by inhibiting action of phospholipase A2 at the site of surgery. Dexamethasone helps by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge and inhibiting potassium channel-mediated discharge of nociceptive C-fibres. Addition of steroid to local anesthetics effectively and significantly prolongs the duration of analgesia as well as producing earlier onset of action in adults. Based upon previous studies as an adjuvant to regional analgesia perineural Dexamethasone significantly shortened the onset of sensory and motor block, prolong duration of analgesia, prolong the time to first analgesic request with minimal side effects. Intravenous Dexamethasone during general anesthesia has proven beneficial in reducing pain, postoperative nausea and vomiting, decreasing airway complications in patients with bronchial hyperreactivity because of worry of physiochemical impacts from perineural adjuvants Dexamethasone, few authors have suggested against its use as an adjuvant to local anesthetic or have proposed that alternative route of administration i.e. intravenous are preferable. Dexamethasone has been used in different doses ranging between 1 to 8 mg. but it has been found that 1, 2 and 4 mg dexamethasone when added to 0.5% Ropivacaine resulted in similar prolongation of motor blockade and analgesia. The present study is undertaken with null hypothesis that perineural and i.v administration of Dexamethasone have no clinical difference in terms of block characteristics. |