| CTRI Number |
CTRI/2021/01/030282 [Registered on: 06/01/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Adding Epinephrine to Bupivacaine and Dexmedetomidine in Ephinephrine Anaesthesia for Lower Limb Surgeries |
|
Scientific Title of Study
|
The Effect of Adding Epinephrine To Combination of 0.5% Bupivacaine and Dexmedetomidine in Epidural anaesthesia for Lower Limb Surgeries - A Prospective, Double Blinded Randomized Control Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRAGYA SHUKLA |
| Designation |
SENIOR RESIDENT |
| Affiliation |
TRAUMA CENTER BHU |
| Address |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221106
India |
| Phone |
9637233147 |
| Fax |
|
| Email |
shukla.pragya0509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANDEEP LOHA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
TRAUMA CENTER BHU |
| Address |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8960919866 |
| Fax |
|
| Email |
drsandeepscb@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEKHAR ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
TRAUMA CENTER BHU |
| Address |
DEPARTMENT OF ANAESTHIOLOGY
TRAUMA CENTER
IMS, BHU
VARANASI
TRAUMA CENTER
IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATIENTS AT TRAUMA CENTER IMS BHU |
|
|
Primary Sponsor
|
| Name |
NOT APPLICABLE |
| Address |
NOT APPLICABLE |
| Type of Sponsor |
Other [NOT APPLICABLE ] |
|
|
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 SHEKHAR ANAND |
TRAUMA CENTER IMS BHU |
DEPARTMENT OF ANAESTHESIOLGY 1ST FLOOR
TRAUMA CENTER IMS BHU
VARANASI
Varanasi
UTTAR PRADESH |
9389006418
shekharanand989@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BANARAS HINDU UNIVERSITY |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S899||Unspecified injury of lower leg, (2) ICD-10 Condition: S929||Unspecified fracture of foot and toe, (3) ICD-10 Condition: S999||Unspecified injury of ankle and foot, (4) ICD-10 Condition: S999||Unspecified injury of ankle and foot, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: O||Medical and Surgical, (7) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (8) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (9) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural anaesthesia at the L2-4 level in sitting position |
Patients were administered epidural block with 18 gauge Touhy needle at the L2-4 level in sitting position, catheter was secured 3–4 cm into epidural space and a test dose of 3 ml of 2% lignocaine hydrochloride solution containing adrenaline 1:200,000 was injected, followed by epidural injections of studied drugs in respective groups. The surgical position was made after complete establishment of sensory and motor blockade.
|
| Comparator Agent |
GROUP A- Combination of bupivacaine 0.5%, dexmedetomidine and 1:1000 epinephrine
|
Group A- bupivacaine 0.5% (1mg/kg), dexmedetomidine 1mcg/kg and 1:1000 epinephrine 5mcg/ml (Epinephrine 1mg/ml, diluted upto 10 ml i.e, 100mcg/ml)
After giving epidural anaesthesia onset of sensory block to level T10, maximum height of dermatome achieved, onset of motor blockade to modified bromage. Modified bromage scale 3, regression of sensory level to dermatome S1, return of motor activity to modified bromage 0 level and total duration of analgesia will be recorded. Sedation score will also be recorded every 10-min interval for the first 30 min and then every 15-min interval till the completion of surgery. |
| Comparator Agent |
GROUP B- Combination of bupivacaine 0.5%, dexmedetomidine and normal saline. |
Group B- Bupivacaine 0.5% (1mg/kg), dexmedetomidine 1mcg/kg and normal saline 1 ml
After giving epidural anaesthesia onset of sensory block to level T10, maximum height of dermatome achieved, onset of motor blockade to modified bromage. Modified bromage scale 3, regression of sensory level to dermatome S1, return of motor activity to modified bromage 0 level and total duration of analgesia will be recorded. Sedation score will also be recorded every 10-min interval for the first 30 min and then every 15-min interval till the completion of surgery. |
|
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Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Lower limb surgery of probable duration of 2hrs.
|
|
| ExclusionCriteria |
| Details |
Patients refusal
Contradiction to regional anaesthesia
Coagulopathy
History of significant coexisting diseases like ischemic heart disease, hypertension, impaired renal functions, rheumatoid arthritis, and severe liver disease
Pregnant patients
Chronic alcoholics and malnourished patients
Atrioventricular block, incomplete or partial heart blocks or intake of beta-blockers
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
After 2 hours every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block & motor block |
After 2 hours every 15 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2021 |
| Date of Study Completion (India) |
30/11/2023 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to evaluate epidural anaesthesia and postoperative analgesia by adding epinephrine to combination of bupivacaine and dexmedetomidine.
In earlier studies, the use of dexmedetomidine as an adjuvant to bupivacaine is a good alternative to other adjuvants like fentanyl in epidural anesthesia, and dexmedetomidine has an edge over fentanyl as an adjuvant when used with bupivacaine in epidural anesthesia. Whereas, addition of epinephrine to bupivacaine resulted in longer duration of analgesia in comparison to plain bupivacaine in labor analgesia.
We hypothesized that epidural 0.5% bupivacaine with dexmedetomidine and adrenaline 1:1000 would be comparable to 0.5% bupivacaine with dexmedetomidine and normal saline, for the efficacy of anesthesia and analgesia, and in addition would provide a better postoperative recovery profile and readiness for discharge.The purpose of the present study is to observe the effect of mentioned study drugs in epidural anaesthesia for duration of sensory and motor block with duration of analgesia.
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