| CTRI Number |
CTRI/2021/01/030449 [Registered on: 14/01/2021] 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 COMBINATION OF ISOBARIC ROPIVACAINE AND DEXMEDETOMIDINE IN EPIDURAL ANAESTHESIA |
|
Scientific Title of Study
|
The Effect of Adding Epinephrine To Combination of 0.75% Ropivacaine
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 SHEKHAR ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
Department of Anaesthesiology
Trauma center
IMS BHU
VARANASI
TRAUMA CENTER,
IMS BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHEKHAR ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY TRAUMA CENTER,
IMS, BHU
VARANASI
TRAUMA CENTER,
IMS, BHU
VARANASI
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09389006418 |
| Fax |
|
| Email |
shekharanand989@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHEKHAR ANAND |
| Designation |
SENIOR RESIDENT |
| Affiliation |
IMS BHU |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY 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 GHANSHYAM YADAV |
TRAUMA CENTER INSTITUTE OF MEDICAL SCIENCES BHU |
DEPARTMENT OF ANAESTHESIOLOGY
1ST FLOOR
TRAUMA CENTER IMS BHU
VARANASI
Varanasi
UTTAR PRADESH |
9838894169
ghanshyambhu1976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee BANARAS HINDU UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (2) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (3) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EPIDURAL ANAESTHESIA |
Patients were administered epidural block with 18 gauge Touhy needle at the L2-4 level in sitting position with all aseptic condition & 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. |
| Comparator Agent |
Group A- Ropivacaine 0.75% , Dexmedetomidine and 1:1000 Adrenaline . |
Group A- ropivacaine 0.75% 13ml, dexmedetomidine (1mcg/kg) and 1:1000 adrenaline 5mcg/ml.
Dose calculation of epinephrine- Epinephrine 1mg/ml, diluted upto 10 ml i.e, 100mcg/ml.
The surgical position was made approximately after 25–30 minutes of epidural administration of drugs in every patient after complete establishment of sensory and motor blockade.
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- Ropivacaine 0.75%, dexmedetomidine and normal saline . |
Group B- Ropivacaine 0.75% 13ml, dexmedetomidine (1mcg/kg) and normal saline 1 ml.
The surgical position was made approximately after 25–30 minutes of epidural administration of drugs in every patient after complete establishment of sensory and motor blockade. 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. |
|
|
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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia |
After 2hrs every 15 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of sensory block & motor block |
After 2hrs 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)
|
17/01/2021 |
| Date of Study Completion (India) |
05/09/2023 |
| 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
|
The study is designed to evaluate efficacy of epidural anesthesia and postoperative analgesia by adding epinephrine to a combination of ropivacaine and dexmedetomidine in lower limb surgeries. Epidural Dexmedetomidine as an adjuvant to Ropivacaine is associated with prolonged sensory and motor blockade, hemodynamic stability, prolonged postoperative analgesia and reduced demand for rescue analgesics when compared to plain Ropivacaine. Whereas Epinephrine, a vasoconstrictor, decreases the absorption of local anesthetics into the bloodstream, which reduces its systemic toxicity when used as an adjuvant. Resulting, prolonged duration of anesthesia. It is also widely used for early differentiation of intravascular absorption. In previous studies epinephrine improves the pain relief and reduces the side effects of a thoracic epidural infusion of ropivacaine and fentanyl after major thoracic or upper abdominal surgery. We hypothesized that epidural isobaric 0.75% ropivacaine with dexmedetomidine and 1:1000 adrenaline would be comparable to isobaric 0.75% ropivacaine 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 analgesia.
|