| CTRI Number |
CTRI/2025/06/088951 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study evaluating the route of administration of dexmedetomidine and dexamethasone in local anaesthetic in patients receiving nerve block for upper limb surgeries. |
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Scientific Title of Study
|
EFFECT OF DEXMEDETOMIDINE AND DEXAMATHASONE ADMINISTRATION ROUTE AS LOCAL ANAESTHETIC ADJUVANT IN BRACHIAL PLEXUS BLOCK A THREE ARM RANDOMISED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pravin K |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Anaesthesiology Pain medicine Critical care Medicine 2nd floor AIIMS Guwahati Changsari Kamrup guwahati
Kamrup
ASSAM
781101
India |
| Phone |
09543735226 |
| Fax |
|
| Email |
ksppravin58@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bheemas B Atlapure |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Anaesthesiology Pain medicine Critical care Medicine 2nd floor AIIMS Guwahati Changsari Kamrup guwahati
Kamrup
ASSAM
781101
India |
| Phone |
9901127633 |
| Fax |
|
| Email |
bheemas4atlapure@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pravin K |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Guwahati |
| Address |
Department of Anaesthesiology Pain medicine Critical care Medicine 2nd floor AIIMS Guwahati Changsari Kamrup guwahati
Kamrup
ASSAM
781101
India |
| Phone |
09543735226 |
| Fax |
|
| Email |
ksppravin58@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
Pravin K |
| Address |
Department of Anaesthesiology Critical care and Pain Medicine Silbharal Changsari AIIMS Guwahati Assam 781101 |
| Type of Sponsor |
Other [Self] |
|
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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 |
| Pravin k |
AIIMS Guwahati |
Department of Anaesthesiology Pain medicine Critical care Medicine 2nd floor AIIMS Guwahati Changsari Kamrup guwahati
Kamrup
ASSAM |
09543735226
ksppravin58@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
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, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Three arm parallel study Group 1 |
Perineural dexmedetomidine 5 mcg plus Intravenous dexamethasone 8 mg |
| Intervention |
Three arm parallel study Group 2 |
Perineural dexamethasone 8 mg plus Intravenous Dexmedetomidine 0.5 mcg per kg |
| Comparator Agent |
Three arm parallel study Group 3 |
Perineural Dexamethasone 8 mg plus Intravenous 0.9 percent Normal Saline |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists ASA physical status I II or III who were scheduled for elective upper extremity surgery under supraclavicular BPB
Both elective and emergency surgeries
|
|
| ExclusionCriteria |
| Details |
Contraindication for BPB Refusal to consent severe coagulopathy sepsis infection at the block site
Preexisting neuropathy of the surgical limb
Pregnancy
BMI more than 35 kg per m2
Patient on an alpha agonist as a hypertensive medication
Uncontrolled Diabetes Mellitus RBS more than 250 mg per dl
Actual body weight less than 40 kg
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Method of Generating Random Sequence
|
Stratified block randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome:
Duration of analgesia time between block completion and the first request for analgesic supplementation
|
Primary outcome:
Duration of analgesia time between block completion and the first request for analgesic supplementation
Secondary outcomes
1 Includes motor block duration defined as the time between block completion and complete resolution of the motor block; a score of 2 in the 3-point modified Bromage score
2. The duration of sensory blockade is defined as the time between block completion (withdrawal of block needle) and resolution of sensory block (Temperature) at the dermatomal level of C5).
3. Sensory block onset (time between block completion and sensory block (Temperature) at the dermatomal level of C5).
4. Motor block onset (time between block completion and achieving score of 1 in 3-point modified Bromage Scale);
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|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes
1 Includes motor block duration defined as the time between block completion and complete resolution of the motor block; a score of 2 in the 3-point modified Bromage score
2. The duration of sensory blockade is defined as the time between block completion (withdrawal of block needle) and resolution of sensory block (Temperature) at the dermatomal level of C5).
3. Sensory block onset (time between block completion and sensory block (Temperature) at the dermatomal level of C5).
4. Motor block onset (time between block completion and achieving score of 1 in 3-point modified Bromage Scale);
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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
|
N/A |
|
Date of First Enrollment (India)
|
26/06/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Title Comparative Evaluation of Perineural Versus Intravenous Administration of Dexmedetomidine and Dexamethasone as Local Anesthetic Adjuvants in Supraclavicular Brachial Plexus Block Introduction Regional anesthesia techniques particularly brachial plexus block BPB are widely used for upper limb surgeries providing effective anesthesia and postoperative analgesia. However the duration of analgesia is often limited leading to rebound pain and increased opioid dependence Adjuvants such as dexmedetomidine and dexamethasone have been introduced to enhance block efficacy but the optimal route of administration remains debated. Objectives To compare the efficacy of perineural versus intravenous dexmedetomidine and dexamethasone in BPB. To evaluate their effects on analgesia duration motor blockade onset and duration postoperative pain sedation hemodynamic stability and patient satisfaction Methodology A randomized controlled trial will be conducted with patients undergoing supraclavicular BPB for upper limb surgeries. Participants will be divided into three groups receiving either perineural dexmedetomidine plus IV dexamethasone or perineural dexamethasone plus IV dexmedetomidine or perineural dexamethasone plus IV saline Outcome measures will include analgesia duration sedation levels blood glucose variations and hemodynamic changes tracked over a 48-hour postoperative period Expected Outcomes Identification of the most effective administration route for prolonged analgesia and optimal motor blockade Evaluation of postoperative pain relief and sedation profiles across groups Recommendations for optimizing regional anesthesia protocols to enhance patient recovery and minimize opioid requirements Conclusion This study will provide valuable insights into anesthetic adjuvant optimization contributing to evidence-based anesthesia practices The findings will aid clinicians in choosing the most effective administration route improving patient outcomes and perioperative safety
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