CTRI Number |
CTRI/2018/02/011923 [Registered on: 15/02/2018] Trial Registered Retrospectively |
Last Modified On: |
19/05/2015 |
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
|
ROLE OF DEXMEDETOMIDINE IN EPIDURAL BLOCK FOR PROLONGED PAIN RELIEF |
Scientific Title of Study
|
To study the effects of dexmedetomidine in two different doses as an adjunct to Ropivacaine in epidural for hip surgeries: A randomized controlled 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 Vishal Devra |
Designation |
JUNIOR RESIDENT |
Affiliation |
Dr. R.P.Govt. Medical College |
Address |
Dr. Vishal Devra,
Depatrment Of Anesthesia,
Dr Rajendra Prasad Government Medical College;
Kangra at Tanda.
Dr. Vishal Devra,
Depatrment Of Anesthesia,
Dr Rajendra Prasad Government Medical College;
Kangra at Tanda. Kangra HIMACHAL PRADESH 176001 India |
Phone |
9805365929 |
Fax |
|
Email |
vishaldevra87@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sudarshan Kumar |
Designation |
Proff. and Head Of Department Of Anesthesia |
Affiliation |
Dr. R.P.Govt. Medical College |
Address |
Dr. Sudarshan Kumar,
Proff. and Head Of Department Of Anesthesia,
DR R.P.G.M.C.
Dr. Sudarshan Kumar,
Proff. and Head Of Department Of Anesthesia,
DR R.P.G.M.C. Kangra HIMACHAL PRADESH 176001 India |
Phone |
09418086604 |
Fax |
|
Email |
sudarshan_58@rediffmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Vishal Devra |
Designation |
JUNIOR RESIDENT |
Affiliation |
Dr. R.P.Govt. Medical College |
Address |
dr. vishal devra,
room no 320,
satluj hostel,
dr r.p.g.m.c.
tanda.
Kangra HIMACHAL PRADESH 176001 India |
Phone |
9805365929 |
Fax |
|
Email |
vishaldevra87@gmail.com |
|
Source of Monetary or Material Support
|
Dr Rajendra Prasad Government Medical College,
Kangra at Tanda,
Himachal Pradesh. |
|
Primary Sponsor
|
Name |
Dr Rajendra Prasad Government Medical College |
Address |
Dr Rajendra Prasad Government Medical College;
Kangra at Tanda.(H.P.) |
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 |
DR VISHAL DEVRA |
DR. R.P.G.M.C TANDA |
Dpartment Of Anesthesia,
Dr. Rajendra Prasad Government Medical College;
Kangra at Tanda. Kangra HIMACHAL PRADESH |
9805365929
vishaldevra87@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Dr Rajendra Prasad Government Medical College Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
ANY PATIENT MEETING INCLUSION CRITERIA AND UNDERGOING HIP SURGERY, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
epidural anesthesia |
TWO DIFFERENT DOSES OF DEXMEDETOMIDINE AS AN ADJUNCT TO ROPIVACAINE IN EPIDURAL FOR POSTOPERATIVE ANALGESIA IN PATIENTS OF HIP SURGERIES |
Comparator Agent |
Group R |
Group R- patients will receive epidural 0.2% Ropivacaine 20mg (10 ml) with 1ml normal saline |
Comparator Agent |
Group RD0.5 |
Group RD0.5- patients will receive epidural 0.2% Ropivacaine 20mg (10 ml) with 0.5mcg/kg dexmedetomidine (preservative free) diluted in normal saline (1ml).
|
Comparator Agent |
Group RD1 |
Group RD1-patients will receive epidural 0.2% Ropivacaine 20mg (10 ml) with 1mcg/kg dexmedetomidine (preservative free) diluted in normal saline (1ml). |
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
ASA Class I-III,
Undergoing Hip Surgeries
|
|
ExclusionCriteria |
Details |
1. Patient’s refusal for the block.
2. Uncontrolled and labile hypertension.
3. Patients using alpha2-adrenergic receptors antagonists
4. Patients noted to have dysrhythmias on the electrocardiogram (ECG).
5. Allergic to study drugs.
6. Absolute contraindication for spinal or epidural anaesthesia.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To study and compare the duration of postoperative analgesia |
Base line
1Min
5 Min
10 Min
15 Min
20 Min
25 Min
30 Min
40 Min
50 Min
60 Min
75 Min
90 Min
105 Min
120 Min
180 Min
240 Min
300 Min
360 Min
8th hour
10th hour
12th hour
15th hour
18th hour
24th hour
|
|
Secondary Outcome
|
Outcome |
TimePoints |
study and compare effects on haemodynamic stability, sedation, respiration |
Base line
1Min
5 Min
10 Min
15 Min
20 Min
25 Min
30 Min
40 Min
50 Min
60 Min
75 Min
90 Min
105 Min
120 Min
180 Min
240 Min
300 Min
360 Min
8th hour
10th hour
12th hour
15th hour
18th hour
24th hour
|
|
Target Sample Size
|
Total Sample Size="90" Sample Size from India="90"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
23/12/2012 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
no publication |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Post oprative pain management is of growing concern in current practice of anesthesia as inadequately controlled postoperative pain can led to higher incidence of chronic post surgical pain, increased stress response, decreased ambulation and increased incidnces of thrombo embolism, postoperative morbidities and worsened patient releted outcomes such as increased hospital stay, poor quality of life. Among the commonly used postop-analgesia methods, patient controlled analgesia (PCA) with opioids, non-steroidal anti-inflammatory drugs (NSAIDS) and epidural LA, epidural LA with adjuncts are the most effective as they provide dynamic pain relief after hip surgeries. Intrathecal and epidural route of administration has an advantage that an analgesic can be administered at the time of giving block with a single injection, which is being utilised for providing anaesthesia for surgery as well as for postoperative pain relief, thereby serving a dual purpose of anaesthesia and postoperative analgesia. Many adjuncts to local anaesthetics have been Used to supplement epidural local anaesthetics for improving and enhancing the quality and duration of anaesthesia, reducing the total dose of local anaesthetics and their side effects, increasing the duration of postoperative analgesia and reduced postoperative analgesic requirements. Adjunct used commonly in central neuraxial blocks are opioids which offer the above mentioned advantages but with side effects like delayed respiratory depression, nausea, vomiting, pruritus, constipation & urinary retention Torben et al examined the dose-response relationship of epidural clonidine at small doses (75 mcg) with respect to prolonging bupivacaine epidural anaesthesia and pain relief. They concluded that small doses of epidural clonidine (75 mcg followed by 18.75 mcg/hr infusion) significantly prolong the anaesthetic and analgesic effects of bupivacaine in a dose-dependent manner without unwarranted side effects like excessive sedation, hypotension and bradycardia Antônio et al concluded that 150 mcg clonidine and 2 mcg/kg dexmedetomidine when added to 0.75%ropivacaine epidurally in cholecystectomy procedures hastened the onset of sensory and motor block and prolonged the duration of the block produced in comparison to the use of ropivacaine alone. Bajwa SS et al found that 1.5 mcg/kg dexmedetomidine and 2 mcg /kg clonidine epidurally when added to 0.75% ropivacaine in patients undergoing vaginal hysterectomies, dexmedetomidine produced significant short onset of sensory and motor block as well as significantly longer duration of sensory and motor block than ropivacaine with clonidine without serious side effects. In another study Bajwa SS et al added 1 mcg/kg dexmedetomidine to 0.75% ropivacaine epidurally which produced prolonged motor and sensory block as compared with addition of 1 mcg/kg fentanyl with ropivacaine in lower limb orthopaedic surgeries. These reviews, aim to give background information to explore the properties and applications of the alpha2-adrenoceptor agonist, and optimal dose of dexmedetomidine epidurally with less worrysome side effects in patients of hip surgeries |