| CTRI Number |
CTRI/2024/07/071614 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to find the duration of postoperative pain relief between two drugs,
Dexmedetomidine and Buprenorphine which are given before the surgery through a needle near shoulder in healthy patients undergoing upper limb surgery.
|
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Scientific Title of Study
|
Comparison of the Analgesic Efficacy of Dexmedetomidine and Buprenorphine as adjuvant to 0.5 Percent Levobupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block in Patients Undergoing Upper Limb Surgeries-A Prospective Randomized Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIRANCHAN RAMANATHAN |
| Designation |
POSTGRADUATE |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Postgraduate, Department of Anaesthesiology,2nd Floor, Hospital Building,
Tagore Medical College and Hospital, Rathinamangalam, Chennai, Tamil Nadu, India,
Pincode-600127.
Chennai TAMIL NADU 600127 India |
| Phone |
7550171454 |
| Fax |
|
| Email |
niranchan.ram@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
NIRANCHAN RAMANATHAN |
| Designation |
POSTGRADUATE |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Postgraduate, Department of Anaesthesiology,2nd Floor, Hospital Building,
Tagore Medical College and Hospital, Rathinamangalam, Chennai, Tamil Nadu, India,
Pincode-600127.
Chennai TAMIL NADU 600127 India |
| Phone |
7550171454 |
| Fax |
|
| Email |
niranchan.ram@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
NIRANCHAN RAMANATHAN |
| Designation |
POSTGRADUATE |
| Affiliation |
Tagore Medical College and Hospital |
| Address |
Postgraduate, Department of Anaesthesiology,2nd Floor, Hospital Building,
Tagore Medical College and Hospital, Rathinamangalam, Chennai, Tamil Nadu, India,
Pincode-600127.
Chennai TAMIL NADU 600127 India |
| Phone |
7550171454 |
| Fax |
|
| Email |
niranchan.ram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,2nd Floor, Hospital Building,
Tagore Medical College and Hospital, Rathinamangalam, Chennai, Tamil Nadu, India,
Pincode-600127. |
|
|
Primary Sponsor
|
| Name |
NIRANCHAN RAMANATHAN |
| Address |
Postgraduate, Department of Anaesthesiology,2nd Floor, Hospital Building,
Tagore Medical College and Hospital, Rathinamangalam, Chennai, Tamil Nadu, India,
Pincode-600127.
|
| Type of Sponsor |
Other [Principal Investigator] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVinodh Mani |
Tagore Medical College and Hospital |
Department of Anaesthesiology,
2nd Floor, Hospital Building,
Tagore Medical College and Hospital, rathinamangalam, Chennai, Tamil Nadu, India, Pin code-600127.
Chennai TAMIL NADU |
9962985906
cellsbeta@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tagore Medical College and Hospital Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buprenorphine, Dose 0.3mg, administered once subcutaneously and duration is 5 minutes |
Supraclavicular block will be performed for 5 minutes under Ultrasound guidance using a 23G Quincke’s insulated Needle after giving local anaesthesia using lignocaine with adrenaline. 0.5% Levobupivacaine 30ml with 50mcg Dexmedetomidine/0.3mg of Buprenorphine will be injected using 23G Quincke’s needle. Onset and Duration of Sensory and Motor Blockade will be collected at every 5 mins for first 30 minutes and entered in the Data Collection Sheet |
| Comparator Agent |
Dexmedetomidine, Dose 50mcg, administered once subcutaneously and duration is 5 minutes |
A total of hundred and twenty patients who are proposed for elective Upper Limb surgeries will be selected for the study and randomly allocated using Random Allocation Software into two groups of sixty each to be administered into the following,
1.0.5% Levobupivacainewith 50mcg Dexmedetomidine (Group A)
2.0.5% Levobupivacaine with 0.3mg Buprenorphine (Group B)
An independent anaesthesiologist who will not participate in the study will prepare the study medication in Syringes and will maintain the records of the allocation. The details of the allocation will be provided to the principal investigator at the end of the data collection.
Monitors will be Connected as per ASA Standards and Baseline hemodynamic parameters will be recorded before the procedure, after achieving sensory and motor blockade, at times of adverse events and at the end of the surgery. End of injection was taken as time 0, thereafter sensory and motor blockade were monitored for every 5 minutes for first 30 mins to find the onset time. Then parameters are monitored till the reappearance of the pinprick response.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 to 65 years who are posted for Upper limb surgeries.
2.American Society of Anaesthesiologists (ASA) physical Status I and II patients.
|
|
| ExclusionCriteria |
| Details |
1.Patients who refuse to give informed written consent.
2.Patients who are medically unstable.
3.Patients with deranged coagulation profile.
4.Patients who are addicted to narcotics.
5.Patients who are allergic to levobupivacaine, ropivacaine, Dexmedetomidine.
6.Pregnant women
7.Patients on opioid medications.
8.Neurological and musculoskeletal disease.
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|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Visual Analogue Scale (VAS) to calculate the duration of Pain relief. Rescue analgesia will be given when VAS score was more than or equal to 4. |
Baseline Visual Analogue Score (VAS) is measured from the time patient is admitted at Postoperative ward and every 60 minutes for next 24 hours. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
To assess the Onset & Duration of sensory & motor blockade, intraoperative & intraoperative Hemodynamics & Sedation.
|
Onset of sensory blockade is defined by a score of 1 on pinprick response.
Onset of motor blockade will be the complete motor paralysis of wrist & hand.
Hemodynamic parameters will be monitored using routine monitors used during a Surgery.
Baseline is measured from the end of the intervention & every 5 minutes after that for next 30 minutes. |
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Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/08/2024 |
| Date of Study Completion (India) |
31/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The brachial plexus nerve block is a novel regional anaesthetic technique which is evolving and flourishing as an adjuvant and sometimes as an alternative to general anaesthesia. Brachial plexus provides a large part of sensory and motor innervation to upper limb, hence, blocking it is an effective method of providing anaesthesia from shoulder to finger tips. It has also been shown to be an attractive option, due to its effectiveness in terms of cost, along with benefit of postoperative analgesia. Several adjuvants can be added to the local anaesthetic to increase the quality and duration of the blockade. Levobupivacaine is an amino-amide long-acting local anaesthetic and the (S)-enantiomer of bupivacaine. It exerts its local anaesthetic effect by blocking voltage-gated sodium channels in the peripheral neurons. Dexmedetomidine a second generation α2 adrenergic receptor specific agent. The increased α2 selectivity results in more predictable and effective sedation and analgesia and fewer side effects. Buprenorphine is a semisynthetic opioid. It has the greater safety margin compared to other classical opioids. It blocks the Na+ channels by binding to the intracellular part of the receptor where the local anaesthetics bind. This study aims to find the analgesic efficacy of buprenorphine and dexmedetomidine as an adjuvant to 0.5% Levobupivacaine in ultrasound guided supraclavicular brachial plexus blocks. |