| CTRI Number |
CTRI/2025/09/094493 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Adductor canal block is a type of injection given near thigh to numb specific nerves that carry pain. The nerve is blocked using certain drugs. The study is conducted in patients undergoing lower limb operations to reduce their pain after operation. |
|
Scientific Title of Study
|
Comparison between Dexmedetomidine Versus Clonidine as Adjuvant to Ropivacaine in Ultrasound Guided Adductor canal block for Post-operative Analgesia in Lower Limb Orthopaedic Surgery: A Prospective Observational Study in a Tertiary Care Hospital in Mandya. |
| 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 Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical College Mandya |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical College Mandya |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivakumar G |
| Designation |
Professor and HOD |
| Affiliation |
Mandya Institute of Medical College Mandya |
| Address |
Department of Anaesthesiology Mandya Institute of Medical College Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9900468451 |
| Fax |
|
| Email |
dranashiv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya Institute of Medical Sciences, Mandya, Karnataka- 571401 |
|
|
Primary Sponsor
|
| Name |
Dr Shivakumar G |
| Address |
Professor and HOD Department of Anaesthesiology
Mandya Institute of Medical Sciences Mandya |
| Type of Sponsor |
Other [] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Archana B N |
Assistant Professor Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya |
| Dr Shwetha A |
Post graduate Student Mandya Institute of Medical Sciences Mandya |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shwetha A |
Mandya Institute of Medical Sciences Mandya |
Major OT complex Department of Anaesthesiology Mandya Institute of Medical Sciences Mandya Karnatka
Mandya
KARNATAKA |
9940839422
shwethaarun08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee |
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 |
Clonidine |
30 ml of Ropivacaine 0.2% with 150 mcg Clonidine is given as single shot dose |
| Intervention |
Dexmedetomidine |
30 ml of Ropivacaine 0.2 % with 100mcg Dexmedetomidine is given as single shot dose |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of height 150-180 cm
Weight 40- 80 kg
Patient undergoing lower limb orthopaedic surgeries
Patients with ASA PS grade 1 and 2.
Patients willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
Patients having any local infection at site of insertion of needle.
patients having any known allergy to local anesthesia, peripheral neuropathy and coagulopathy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesia of clonidine and dexmedetomidine as adjuvant to 0.2% ropivacaine in adductor canal block
To compare the intraoperative hemodynamic parameters between the groups. |
To compare the adverse effects and the sedation scores between the groups upto a duration of 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the adverse effects and sedation scores between the groups |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2025 |
| 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="6"
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
|
Various adjuvants have been added in peripheral nerve block to prolong the duration of analgesia. The present study is conducted to compare the clinical efficacy between Clonidine and Dexmedetomidine as adjuvants to Ropivacaine in ultrasound guided Adductor canal block in parameters of sensory blockade, duration of analgesia, number of rescue analgesia required in 24 hours and perioperative complications. The study is mainly conducted for post operative analgesia for patients undergoing elective lower limb orthopaedic surgeries. The adjuvants used in this study prolongs the duration of analgesia in the patients. Dexmedetomidine and clonidine are both having alpha 2 agonistic action and thus when added to a local anaesthetic like ropivacaine, have synergestic action. |