| CTRI Number |
CTRI/2026/02/104595 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two Pain Relieving Add on Medicines with Local Anaesthetic for Numbing the Arm During Upper Limb Surgeries |
|
Scientific Title of Study
|
Comparative Clinical Study Of Dexmedetomidine And Clonidine As Adjuvants To Levobupivacaine In Supraclavicular Brachial Plexus Block In Upper Limb Surgeries. |
| 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 Ajeet Jyotipurkar |
| Designation |
Assistant Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur |
| Address |
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Nagpur MAHARASHTRA 440017 India |
| Phone |
9561306782 |
| Fax |
|
| Email |
ajeet.jyotipurkar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajeet Jyotipurkar |
| Designation |
Assistant Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur |
| Address |
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Nagpur MAHARASHTRA 440017 India |
| Phone |
9561306782 |
| Fax |
|
| Email |
ajeet.jyotipurkar@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajeet Jyotipurkar |
| Designation |
Assistant Professor |
| Affiliation |
NKP Salve Institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital Nagpur |
| Address |
Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Department of Anaesthesiology, NKP Salve Institute Of Medical Sciences and Research Centre and Lata Mangeshkar Hospital,Digdoh Hills, Hingana road, Nagpur 440017 Nagpur MAHARASHTRA 440017 India |
| Phone |
9561306782 |
| Fax |
|
| Email |
ajeet.jyotipurkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| NKP Salve Institute of Medical Sciences & Research centre and Lata Mangeshkar Hospital Nagpur |
|
|
Primary Sponsor
|
| Name |
NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital |
| Address |
Department Of Anaesthesiology, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road,Nagpur |
| 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 Ajeet Jyotipurkar |
Lata Mangeshkar Hospital, Nagpur |
Department of Anaesthesiology, Fourth Floor, Operation theatre complex, NKP Salve Institute of Medical Sciences, Digdoh Hills, Hingna Road, Nagpur Nagpur MAHARASHTRA |
9561306782
ajeet.jyotipurkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NKP Salve Institute of Medical Sciences and Lata Mangeshkar Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Levobupivacaine with Dexmedetomidine And Levobupivacaine with Clonidine. |
19ml of 0.5% Levobupivacaine and 0.75 mcg/kg of Dexmedetomidine diluted to 1ml with Normal Saline for a total volume of 20ml And
19ml of 0.5% Levobupivacaine and 1 mcg/kg of Clonidine diluted to 1ml with Normal Saline for a total volume of 20ml |
| Intervention |
Supraclavicular block |
Supraclavicular brachial plexus block will be performed for providing anaesthesia and analgesia for upper limb surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists physical status 1 and 2
Body Mass Index less than 30 kg per m2.
|
|
| ExclusionCriteria |
| Details |
History of allergy to study drug.
Infection at the site of injection.
Coagulopathies.
Patients on Beta blockers.
Neurological deficit in the operating arm.
Patients on anti psychotic and anti epileptic drugs.
Patient not willing to participate. |
|
|
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 |
To evaluate efficacy of Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
1.Onset of sensory blockade .
2.Onset of motor blockade.
3.Duration of sensory blockade
4.Duration of motor blockade.
5.Intensity of motor blockade. |
Time of completion of injection of local anaesthetic will be labelled as 0 minutes
After the block performance assessment of onset and duration of sensory block will be done by loss of sensation of pin prick
onset and duration of motor block assessment will be done by bromage scale.
Assessment of sensory and motor blockage will be done every 5 mins post block performance till 30 mins and then at an interval of 1 hr post surgery till the first 12 hrs and until the block had worn off completely.
Assessment of intensity of motor blockade will be assessed every 5 mins till grade 3 motor block is achieved. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate postoperative analgesia with Dexmedetomidine as an adjuvant to 0.5% Levobupivacaine versus Clonidine with 0.5% Levobupivacaine in Ultrasound-Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries in terms of
1.Visual analogue score for pain assessment.
2.Time for requirement of first rescue analgesia.
3.Total analgesic requirement in 24 hours.
4.Complications like Hypotension , Bradycardia , Sedation. |
Time of completion of injection of local anaesthetic will be labelled as 0 minutes.
Visual Analog Score will be assessed immediately post operatively
Total rescue analgesia will be assessed in 24 hours
Hemodynamic parameters and sedation will be monitored every 5 mins for first 30 mins and then every 30 mins for the rest of the surgery. |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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 |
|
Date of First Enrollment (India)
|
15/03/2026 |
| 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
|
Regional blocks have secured a pivotal role in modern anaesthetic practice with their ability to achieve ideal operative conditions without much of systemic side effects. They offer an excellent alternative for patients who are hemodynamically compromised or too ill to tolerate general anaesthesia . For the majority of upper limb surgeries carried out on a daily basis, supraclavicular brachial plexus blockade is the technique of choice due to its effectiveness in terms of success rates, margin of safety, and efficient postoperative analgesia . The first supraclavicular brachial plexus block was performed by Kulenkampff D in 1912 .Though relatively new, ultrasonographic visualization of the targeted nerves shows promise for the future. This makes it possible to see the block needle, the distribution of local anesthetic, and peripheral nerves directly. Past few years have observed a great increase in the use of ultrasound for regional nerve blocks. An ideal drug should have a fast sensory onset, differential offset, with an earlier offset of motor than sensory blockade, enabling early ambulation or movements with prolonged analgesia. Several combinations of LAs and adjuvants such as tramadol, sufentanil, clonidine and fentanyl have been employed in the search for near ideal agent, which has proven to be unattainable Currently, levobupivacaine ie S enantiomer of bupivacaine with favorable clinical profile and lesser cardiotoxicity when compared with racemic bupivacaine is being favoured LA for regional block. Dexmedetomidine, a pharmacologically active dextro-isomer of medetomidine, is a selective alpha 2 adrenoceptor agonist employed for use as an adjuvant during regional anaesthesia.It inhibits the neuronal conduction by blocking hyperpolarization activated cation currents and produces analgesia. Dexmedetomidine has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of dexmedetomidine, such as 1to 2 mcg per kg, but at the expense of more adverse effects, such as bradycardia and hypotension.There are very few studies which evaluated the efficacy of low dose ie 30mcg of dexmedetomidine as an adjuvant to local anaesthetic to prolong the block characteristics. Clonidine had been used as an adjunct to local anaesthetic agents in various regional techniques to extend the duration of block. It is a centrally acting alpha-2 adrenergic agonist. It has been added perineurally at various doses; however, the optimal dose is still unknown. Analgesia lasts longer at higher doses of clonidine. Hence this study aims to evaluate the efficacy of 0.5 mcg per kg dexmedetomidine with 0.5 percent levobupivacaine versus 1 mcg per kg clonidine with 0.5 percent levobupivacaine in ultrasound guided supraclavicular block which can be beneficial to Indian population. |