| CTRI Number |
CTRI/2025/04/084011 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare analgesic effects of two adjuvants when used with same local anaesthetic in axillary brachial plexus block for forearm and hand surgeries. |
|
Scientific Title of Study
|
A Double Blind Randomized Controlled Trial for analgesic role of Dexmedetomidine vs Dexamethasone as adjuvant in Axillary Brachial plexus block in forearm and hand 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 |
Hena Ahmed Khan |
| Designation |
Post Graduate Trainee |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata
Kolkata
WEST BENGAL
700058
India |
| Phone |
8961718567 |
| Fax |
|
| Email |
khan.a.hena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anjan Das |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
OT Complex, College of Medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata
Kolkata
WEST BENGAL
700058
India |
| Phone |
9874171440 |
| Fax |
|
| Email |
anjan2k8@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anjan Das |
| Designation |
Professor, Department of Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
OT Complex, College of Medicine and Sagore Dutta Hospital, Department of Anaesthesiology, 578, Barrackpore Trunk Road, Kolkata
Kolkata
WEST BENGAL
700058
India |
| Phone |
9874171440 |
| Fax |
|
| Email |
anjan2k8@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, College of Medicine and Sagore Dutta Hospital, 578, Barrackpore Trunk Road, Kamarhati, Kolkata, West Bengal, India, 700058. |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital, 578, Barrackpore Trunk Road, Kamarhati, Kolkata, West Bengal, India, 700058. |
| Type of Sponsor |
Government 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 |
| Prof Dr Anjan Das |
College of Medicine and Sagore Dutta Hospital |
OT Complex, 578, Barrackpore Trunk Road, Kamarhati.
Kolkata
WEST BENGAL |
9874171440
anjan2k8@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, College of Medicine and Sagore Dutta Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Axillary Brachial Plexus Block with 0.5% Levobupivacaine and
Dexmedetomidine (50 mcg) |
30 ml of 0.5% Levobupivacaine (150
mg) and 0.5 ml Dexmedetomidine
(50 mcg) with 1.5 ml Distilled Water; Dose: Levobupivacaine (2-3mg/kg), Dexmedetomedine (1-1.2mcg/kg) ; Frequency: Once ;
Site: Perineural infiltration of
brachial plexus by axillary
approach. Duration of
procedure: 10 minutes |
| Comparator Agent |
Axillary Brachial Plexus Block with 0.5% Levobupivacaine and Dexamethasone (8 mg) |
30 ml of 0.5% Levobupivacaine (150 mg) and 2 ml Dexamethasone (8 mg); Dose: Levobupivacaine (2-3 mg/kg), Dexamethasone (8 mg); Frequency: Once ; Site: Perineural infiltration of brachial plexus by axillary approach. Duration of procedure: 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA Grade I and II.
2. Enrolled for elective forearm and hand surgery under axillary brachial plexus block. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal for either the axillary brachial block or participation in the study.
2. Any hypersensitivity or contraindication to study drugs.
3. Pregnant or lactating mothers.
4. Hepatic, renal, or cardiopulmonary abnormality.
5. Chronic alcoholism, uncontrolled hypertension, diabetes, long-term drug therapy.
6. Bleeding diathesis, local skin site infections.
7. History of significant neurological, psychiatric, or neuromuscular disorders (generalized or regional).
8. Patients who have undergone any other clinical trial within the last 3 months.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean analgesic duration between two groups. |
6 hours and 12 hours in post-operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the onset time of sensory & motor block among the two groups.
2. To compare the haemodynamic changes (heart rate & mean blood pressure) among two groups.
3. To compare the total analgesic need among the two groups (over 24 hrs).
|
1. 0 minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes.
2. 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes in the intra-operative period, 150 minutes, 210 minutes, 270 minutes, 330 minutes, 390 minutes, 450 minutes, 510 minutes, 570 minutes, 630 minutes, 690 minutes, 720 minutes in the post-operative period.
3. Up to 24 hours in the post-operative perod.
|
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Patient compliance and duration of analgesia are two very important
aspects of anaesthetic care. Therefore, in recent times it is quite essential
to formulate better combination of drugs that provide adequate analgesia for
longer duration. Dexamethasone has
commonly been used for extension of spinal anaesthesia duration. Alpha-2 agonists are
often mixed with local anaesthetic agents to extend the duration of spinal,
epidural and peripheral nerve blocks. Our study
will compare the efficacy of dexmedetomidine as adjuvant to 0.5% Levobupivacaine
versus dexamethasone as adjuvant to 0.5% Levobupivacaine for prolongation of
duration of analgesia with axillary brachial plexus block in forearm and hand surgeries. There is paucity of studies comparing Dexamethasone and Dexmedetomidine with
local anaesthetic agents in axillary brachial plexus block. Hence, the study
will be beneficial to compare the effect of an alpha 2 agonist with respect to
a steroid when used with a local anaesthetic agent in prolonging the duration
of analgesia.
Expected outcome: The use of
dexmedetomidine as an adjuvant to 0.5% levobupivacaine should provide longer duration of
analgesia than dexamethasone as an adjuvant to same drug. Both the drugs are haemodynamically
stable but slightly more bradycardia is seen with dexmedetomidine. In the outcome of our
proposed study, it will be determined whether there is any significant
difference in prolonging the
duration of analgesia and reducing postoperative pain while using dexmedetomidine
with respect to dexamethasone as adjuvants to 0.5% levobupivacaine in axillary brachial plexus
block and to assess different adverse effects of both.
|