| CTRI Number |
CTRI/2024/07/070502 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study between Clonidine and Buprenorphine as adjuvants Ropivacaine in Ultrasound guided Infraclavicular Brachial Plexus Block |
|
Scientific Title of Study
|
A comparative study between Clonidine and Buprenorphine as adjuvants to 0.5 percent Ropivacaine in Ultrasound guided Infraclavicular Brachial Plexus Block |
| 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. Pramathesh A |
| Designation |
post graduate student |
| Affiliation |
Department of Anaesthesiology |
| Address |
Vydehi Institute of Medical Sciences and Research Centre, whitefield, Bangalore
Bangalore KARNATAKA 560066 India |
| Phone |
7760498220 |
| Fax |
|
| Email |
pramathesh.a@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Shishir KR |
| Designation |
Associate professor |
| Affiliation |
Department of Anaesthesiology |
| Address |
Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore
Bangalore KARNATAKA 560066 India |
| Phone |
|
| Fax |
|
| Email |
shishirsmashes@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Pramathesh A |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesiology |
| Address |
Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore
Bangalore KARNATAKA 560066 India |
| Phone |
7760498220 |
| Fax |
|
| Email |
pramathesh.a@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vydehi Institute of Medical Sciences and Research Center, Whitefield, Bangalore-560066 |
|
|
Primary Sponsor
|
| Name |
vydehi institute of medical sciences and research centre |
| Address |
whitefield, bangalore-560066 |
| 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 Pramathesh A |
vydehi institute of medical sciences and research centre |
Department of Anaesthesiology, Whitefield, bangalore-560066 Bangalore KARNATAKA |
7760498220
pramathesh.a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vydehi Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: T07||Unspecified multiple injuries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
buprenorphine |
Buprenorphine is a dehydroxylated phenanthrene and is chemically similar to other opioids such as hydrocodone, oxycodone, levorphanol, hydromorphone, oxymorphone, and others. Buprenorphine is a partial agonist at the m-opioid receptor (MOR) and an antagonist at k receptors. As a partial agonist, buprenorphine is able to activate MORs at low to moderate doses and it can achieve the same or superior analgesia compared to a full m-opioid agonist
administered in a dose of 2mcg/kg body weight |
| Comparator Agent |
clonidine |
Clonidine, a selective alpha-2 adrenergic agonist inhibits nociceptive impulses by activating postjunctional alpha-2 adrenoreceptors both at peripheral and spinal nerve endings. It improves block characteristics of local anaesthetics in peripheral nerve blocks without producing any side effects like sedation, bradycardia and hypotension as seen in spinal blocks
Administered as a dose of 1.5mcg/kg body weight |
| Intervention |
INFRACLAVICULAR BRACHIAL PLEXUS BLOCK |
Regional anaesthesia is comparatively safer and does not involve the potential side effects and complications that may arise from sedation and general anaesthesia. It is also effective as it more acceptable amongst the patients, thus providing the doctors an increased patient compliance and consent for surgery. The infraclavicular block is a safe and effective approach for Brachial plexus block that can provide anaesthesia for hands, wrist and forearm.
Administered as 30ml of 0.5% Ropivacaine along with either 1.5mcg/kg of Clonidine or 2mcg/kg of Buprenorphine |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex, aged 21-60 years, undergoing elective upper limb surgeries.
2. Patients belonging to American Society of Anesthesiologist (ASA) physical status I, II.
3. Patients within the weight range of 50-80kgs and within normal BMI.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal for the study.
2. Patients with coagulopathy or on anticoagulants.
3. Patients with pre-existing neuropathy involving brachial plexus.
4. Patients who have undergone prior surgeries of the infraclavicular fossa.
5. Patients with localized skin infections at site of block.
6. Patients with hypersensitivity to local anaesthetic
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate and compare the onset for sensory blockade.
2. To evaluate and compare the onset for motor blockade.
3. To evaluate and compare the duration of sensory blockade.
4. To evaluate and compare the duration of motor blockade.
|
5 mins
10 mins
15 mins
20 mins
25 mins
30 mins
1 hour
2 hours
3 hours
6 hours
12 hours
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess hemodynamic variables.
2. To identify adverse effects to the drugs.
|
hemodynamic variables are monitored in patients who receive the block for a duration of 24 hours & the at an interval sterting with 0min, 15min, 30min, 45min, 1hr, 2hrs, 3hrs, 6hrs, 12hrs & 24hrs
Adverse effects are noted upto a duration of 24hours if any |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2024 |
| 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="3" 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - available in person
- For how long will this data be available start date provided 17-03-2024 and end date provided 17-03-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
General anaesthesia was one of the
most common methods employed to provide anaesthesia for upper limb surgeries.
With the introduction of newer and safer local anaesthetics and better
advantages, regional anaesthesia has taken over as the principal technique for
upper limb surgeries.
Regional anaesthesia is comparatively
safer and does not involve the potential side effects and complications that
may arise from sedation and general anaesthesia. It is also effective as it
more acceptable amongst the patients, thus providing the doctors an increased
patient compliance and consent for surgery. The infraclavicular block is a safe
and effective approach for Brachial plexus block that can provide anaesthesia
for hands, wrist and forearm.
Ropivacaine is a propyl analogue of
bupivacaine that has the same potency with longer duration of action and lesser
cardiac and central nervous system toxicity of bupivacaine. Several adjuvants can
be used to lengthen the duration of infraclavicular brachial plexus block such
as clonidine, opioids, neostigmine, midazolam and buprenorphine
[1].
Clonidine, a selective alpha-2
adrenergic agonist inhibits nociceptive impulses by activating postjunctional
alpha-2 adrenoreceptors both at peripheral and spinal nerve endings. It
improves block characteristics of local anaesthetics in peripheral nerve blocks
without producing any side effects like sedation, bradycardia and hypotension
as seen in spinal blocks
[2].
Buprenorphine is a dehydroxylated phenanthrene and is
chemically similar to other opioids such as hydrocodone, oxycodone,
levorphanol, hydromorphone, oxymorphone, and others. Buprenorphine is a partial
agonist at the m-opioid receptor (MOR) and an antagonist at k receptors. As a
partial agonist, buprenorphine is able to activate MORs at low to moderate
doses and it can achieve the same or superior analgesia compared to a full m-opioid
agonist [3].
There are studies that compare the effects of adding
clonidine as an adjuvant to ropivacaine or bupivacaine for brachial plexus blocks
[1]. But there are
limited studies with buprenorphine as an adjuvant in infraclavicular blocks.
After thorough research in literature, it was concluded that
limited data is available that compares and assess the effects of these drugs
as adjuvants to ropivacaine.
Hence, this study is being undertaken which intends to
compare and evaluate the effects of clonidine and buprenorphine as adjuvants to
ropivacaine in infraclavicular brachial plexus blocks. |