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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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