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CTRI Number  CTRI/2013/12/004250 [Registered on: 27/12/2013] Trial Registered Retrospectively
Last Modified On: 26/12/2013
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFICACY OF BUPIVACAINE WITH DEXMEDETOMODINE FOR BRACHIAL PLEXUS BLOCK  
Scientific Title of Study   COMPARISION OF EFFECT OF 0.25% BUPIVACAINE WITH DEXMEDETOMODINE AND 0.25% BUPIVACAINE ALONE IN BRACHIAL PLEXUS BLOCK BY SUPRACLAVICULAR APPROACH 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpa S N 
Designation  post graduate resident 
Affiliation  Father Muller Medical College 
Address  Dr Shilpa S N,post graduate resident, Department of Anaesthesiology,Father Muller Medical College, Kankanady, Mangalore.
room no 310,Anaesthesia PG, Ave Maria Hostel,Father Muller Medical College, Kankanady, Mangalore- 575002
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9916275903  
Fax    
Email  shilpa.sn.bly@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Radhesh Hegde 
Designation  Professor and HOD 
Affiliation  Father Muller Medical College 
Address  Professor and HOD, Department of anaesthesiology, Father Muller Medical College, Kankanady, Mangalore
Flat No:4,Venus Manor, Kadri Kamba junction, Kadri, Mangalore-575002
Dakshina Kannada
KARNATAKA
575002
India 
Phone  9845085007  
Fax    
Email  radheshhegde68@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Radhesh Hegde 
Designation  Professor and HOD 
Affiliation  Father Muller Medical College 
Address  Professor and HOD, Department of anaesthesiology, Father Muller Medical College, Kankanady, Mangalore
Flat No:4,Venus Manor, Kadri Kamba junction, Kadri, Mangalore-575002

KARNATAKA
575002
India 
Phone  9845085007  
Fax    
Email  radheshhegde68@gmail.com  
 
Source of Monetary or Material Support  
Dr Shilpa S N 
 
Primary Sponsor  
Name  Father Muller Medical College 
Address  Department of Anaesthesiology, Father Muller Medical College, Kankanady, Mangalore-575002 
Type of Sponsor  Private 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 Shilpa S N  father muller medical college  Father muller medical college, Kankanady, Mangalore-575002
Dakshina Kannada
KARNATAKA 
9916275903

shilpa.sn.bly@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Father Muller Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  patients posted for upper limb orthopaedic surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine with bupivacaine  single dose of dexmedetomidine 0.5ml (50mcg)with o.25% 34ml bupivacaine is injected into brachial plexus through supraclvicular approach before the surgery 
Comparator Agent  plain bupivacaine  single dose of 0.25%, 34ml bupivacaine will be injected into brachial plexus through supraclavicular approach before the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA(American Society of Anaesthesiologists) grade 1 and 11
2. between the ages of 18-60years, of either sex
3. Undergoing orthopaedic surgeries on upper limb
 
 
ExclusionCriteria 
Details  1. Patients on adrenoreceptor agonist and antagonist therapy
2. Known hypersensitivity to local anaesthetics
3. Uncontrolled diabetes milletus
4. Pregnant woman
5. Preexisting peripheral neuropathy
6.Patients with bleeding disorder
7. ASA 111 and above
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of 0.25% bupivaciane with dexmedetomidine and 0.25% bupivaciane alone in brachial plexus block  11/10/2012 to 11/10/2014 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the effects of 0.25% bupivacaine with dexmedetomodine in brachial plexus block
2.To study the effects of 0.25% bupivacaine in brachial plexus block
 
11/10/2012 to 11/10/2014 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   11/10/2012 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

NEED FOR THE STUDY:

            Peripheral nerve blocks not only provide intraoperative anaesthesia but also extend analgesia in the postoperative period without any systemic side effects.(1)

            There has always been a search for adjuvants to the regional block with drugs that prolongs the duration of analgesia with lesser adverse effects.(1) Many drugs have been tried like opiods, clonidine, hyaluronidase, dexamethasone, midazolam.(7)

            Alpha2 adrenergic receptor agonists have been tried either alone or in combination with another drug to prolong anaesthesia in various methods of anaesthetic administration like epidural, intrathecal and regional nerve blocks.(1) Dexmedetomidine is an α2 receptor agonist and its α 2/α1 selectivity is 8 times more than clonidine.2 Several studies have found dexmedetomidine to be safe and effective in various neuraxial and regional anaesthesia in humans including intrathecal and IV regional anaesthesia with lesser side effects.(2,3)

            The aim of this study is to evaluate the effect of addition of dexmedetomidine to 0.25% bupivacaine in brachial plexus block.

REVIEW OF LITERATURE:

            Saritha et al, conducted a study in 2012 and reported that Dexmedetomidine when added to local anaesthetics in supraclavicular brachial plexus block enhanced the duration of sensory and motor block and also duration of analgesia. It also enhanced the quality of block as compared with clonidine.(1)

           Aliye maoglu et al conducted double a blind randomized controlled study on 60 patients in 2010 and reported that dexmedetomidine added to levobupivacaine for axillary brachial plexus block shortens the onset time and prolongs the duration of block and duration of postoperative analgesia.(2)

                Rachana Gandhi et al conducted a prospective double blind study in 2012 and reported that when dexmedetomidine added to bupivacaine have better hemodynamic stability and greater postoperative analgesia as compared to only bupivacaine used in brachial plexus block.(3)

               Amany S.Ammar et al in their study on brachial plexus block reported that addition of dexmedetomidine to bupivacaine during brachial plexus block provides enhancement of onset and motor blockade, prolonged duration of analgesia, increases duration of sensory and motor block, yields lower verbal response scale pain scores and reduces supplemental opiod requirements.(4)

                Rutkowska et al conducted a study in 2009 on intravenous dexmedetomidine on brachial plexus block in patients with end stage renal disease and showed added dexmedetomidine prolongs the duration of brachial plexus block.(5)

            A. Duma  et al conducted a prospective randomised controlled double blind trial in 2005 and reported that adding clonidine to bupivacaine or levobupivaaine in brachial plexus block significantly increases the duration of block.(6)

            Esmaoglu et al conducted study in 2005 and reported that addition of dexmedetomidine  to lidocaine during intravenous regional anaesthesia improves the quality of anaesthesia and intraoperative as well postoperative analgesia without side effects.(7)

                Koj Jarbo  et al in their study in 2005 has shown that adding midazolam to bupivacaine hastened onset of sensory and motor block and improved postoperative analgesia when used in brachial plexus block.(8)

            Bazin et al reported sustained analgesic effect from opiods(sufentanil) used in supraclavicular brachial plexus block compared with saline.(9)

OBJECTIVES OF THE STUDY:

1.To study the effects of 0.25% bupivacaine with dexmedetomodine in brachial plexus block

2.To study the effects of 0.25% bupivacaine in brachial plexus block

3.To compare the effects of 0.25% bupivaciane with dexmedetomidine and 0.25% bupivaciane alone in brachial plexus block

 

MATERIAL  AND METHODS

      SOURCE OF DATA :

    Patients posted for elective orthopaedic surgeries on the upper limb admitted in Father Muller Medical College Hospital from August 2012 to July 2014.

7.2 METHOD OF COLLECTION OF DATA:

 

Study type: Prospective Randomised, Double blind study

Duration of study: Two years

Sample size: 60 patients selected using purposive sampling technique

INCLUSION CRITERIA:

            Patients for  orthopaedic surgeries on upper limbs:-

    1. ASA(American Society of Anaesthesiologists) grade 1 and 11

    2. between the ages of 18-60years, of either sex

    3. Undergoing orthopaedic surgeries on upper limb

  EXCLUSION CRITERIA:

       Patients with:-

    1. Patients on adrenoreceptor agonist and antagonist therapy

    2. Known hypersensitivity to local anaesthetics

    3. Uncontrolled diabetes milletus

    4. Pregnant woman

    5. Preexisting peripheral neuropathy

    6.Patients with bleeding disorder      

 7. ASA 111 and above                                                                                                                                        

METHODOLOGY:

        After approval of institutional ethical committee, 60 consenting patients fulfilling the inclusion criteria will be considered for our study. A pre-anesthetic checkup will be done for all patients which will include a detailed history, general physical and systemic examination. Basic investigations will be done (Hb%, complete blood counts, bleeding time, Clotting time, random blood sugar, serum urea, serum creatinine, if age is above 45yrs then ECG). Patients will be kept nil per oral overnight.

     Selected patients will be divided randomly into two groups using “slips in a box technique” of 30 each, with

 GROUP A:34ml of 0.25% Bupivacaine with 0.5ml(50µg) dexmedetomidine

 GROUP B:34ml of  0.25% Bupivacaine with 0.5ml 0.9% saline

 

     On arrival in the operating room, baseline heart rate, blood pressure and oxygen saturation will be recorded. An intravenous line will be secured in the unaffected limb and ringer lactate will be started. All the patients will be receiving brachial plexus block through the supraclavicular approach by an experienced anaesthesiologist different from the one assessing the patient intra and postoperatively. Both will be blinded to the treatment groups.

     Neural localization will be achieved using nerve stimulator, following negative aspiration, the solution containing local anaesthetic combined with dexmedetomidine or normal saline as mentioned above will be injected.

    Sensory block will be assessed by pinprick test using 3-point scale

0

Normal sensation

1

Loss of sensation of pinprick(analgesia)

2

Loss of sensation of touch(anasthesia)

   

Motor blockade will be done using Bromage three point score

1

Normal sensation

2

Decreased motor strength with ability to move fingers only

3

Complete motor block with inability to move fingers

      Sensory and motor blocks will be evaluated every 3 minutes until 30minutes after injection.

       Onset time of sensory block defined as the time interval between the end of total local anaesthetic administration and complete sensory block. Duration of sensory block was defined as the time interval between end of local anaesthetic administration and complete resolution of anaesthesia on all nerves.

            Onset of motor block defined as the time interval between the end of local anaesthetic administration and complete motor block. Duration of motor block is defined as time interval between end of local anaesthetic administration and complete resolution of motor block.

       Heart rate, systolic blood pressure(SBP), diastolic blood pressure(DBP) and saturation of oxygen(SpO2) will be recorded at 0 minutes,5 minutes,10 minutes,15 minutes,30 minutes,45 minutes,60 minutes,90 minutes and 120 minutes. Adverse events like hypotension (20% decrease in relation to baseline) and bradycardia (heart rate <50 beats per minute) will be corrected with appropriate measures. Duration of motor and sensory blockade after surgery will be recorded.

    Rescue analgesia diclofenac sodium 75mg IM will be given when patient visual analogue score >5.

0-      No pain

10- worst possible pain

STATISTICAL ANALYSIS:

Collected data will be analysed by ANOVA (analysis of variance) for repeated measures Chi-square test and Unpaired T-test.

 
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