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CTRI Number  CTRI/2016/04/006823 [Registered on: 13/04/2016] Trial Registered Retrospectively
Last Modified On: 13/04/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a study to search a suitable dose of a drug, dexmedetomidine for early onset and prolongation of anaesthesia in brachial plexus block. 
Scientific Title of Study   Comparitive evaluation of two doses of dexmedetomidine added to levobupivicaine for brachial plexus block. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  chandni sinha 
Designation  assistant professor 
Affiliation  assistant professor, Department of Anaesthesia 
Address  department of anaesthesia, faculty room, ot complex, 3rd floor, ayush pmr building, aiims, patna

Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  chandni sinha 
Designation  assistant professor 
Affiliation  assistant professor, Department of Anaesthesia 
Address  department of anaesthesia, faculty room, ot complex, 3rd floor, ayush pmr building,aiims, patna
aiims residential complex
Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dr chandni sinha 
Designation  assistant professor 
Affiliation  assistant professor, Department of Anaesthesia 
Address  department of anaesthesia, faculty room, ot complex, 3rd floor, ayush pmr building, aiims, patna

Patna
BIHAR
801505
India 
Phone  06122451205  
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
Dr. Chandni Sinha, faculty room, ot complex, 3rd floor, ayush pmr building, AIIMS, Patna 
 
Primary Sponsor  
Name  AIIMSPatna 
Address  Department of Anaesthesia, OT complex, 3rd floor, ayush pmr building, AIIMS, Patna 
Type of Sponsor  Research institution and hospital 
 
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 Chandni Sinha  AIIMS,Patna  OT complex, 3rd floor, ayush PMR Building, aiims, patna
Patna
BIHAR 
06122451205

chandni.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS patna IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  ASA I/II scheduled for upper limb orthopaedic procedures 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexmedetomidine 1ug/kg  dexmedetomidine 1 ug/kg added to 0.5% levobupivicaine 20 cc 
Comparator Agent  dexmedetomidine 2 ug/kg  dexmedetomidine 2ug/kg added to 20 cc 0.5% levobupivicaine 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age : 18 to 60 years
2. ASA I and II
3. Posted for Forearm/ elbow surgeries
 
 
ExclusionCriteria 
Details  1. ASA III or more
2. Bleeding / coagulation disorder
3. Uncontrolled diabetes/ HTN
4. Patients with heart blocks/ cardiac disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
duration of analgesia: time between the block and the first analgesic requirement(VAS4)  pain will be assessed hourly after six hours till 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1. duration of sensory blockade
2. duration of motor blockade 
1.block will be assessed hourly after surgery till 24 hours
2.motor blockade will be assessed hourly after the end of surgery till twenty four hours. 
3.to study the effect on hemodynamics(heart rate and mean arterial pressure)  every 15 minutes till three hours 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/12/2015 
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="1"
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  

INTRODUCTION

Upper limb surgeries are preferably done under regional anesthesia. Peripheral nerve blocks not only provide for intra operative anesthesia but also ensure analgesia in the post operative period without any systemic side effects. Levobupivacaine, is a new local anaesthetic having, similar pharmacological profile, but less cardiotoxicity when compared to Bupivacaine.

There has always been a search for ideal adjuvants in peripheral nerve blocks which prolong the duration of analgesia with lesser adverse effects. Various adjuvants used are clonidine, dexamethasone, tramadol etc. Lately dexmedetomidine highly selective α2 adrenergic agonist, has been used as an adjuvant to local anaesthetics. Very few clinical trials have studied the effect of dexmedetomidine as an adjuvant to levobupivicaine in supraclavicular brachial plexus block. Only a single dose of 100 ug has been studied which has been associated with hemodynamic changes.  We aim to compare the efficacy and adverse effect of 2 doses of dexmedetomidine (1ug/kg and 2ug/kg) added to levobupivicaine.

MATERIALS AND METHOD

After obtaining clearance from IEC, 90 ASA I and II patients between the age group 18 to 60 scheduled for upper limb orthopaedic surgeries under supraclavicular brachial plexus block will be included in the study.

INCLUSION CRITERIA

1.      Age : 18 to 60 years

2.       ASA I and II

3.      Posted for Forearm/ elbow surgeries

EXCLUSION CRITERIA

1.      ASA III or more

2.      Bleeding / coagulation disorder

3.      Uncontrolled diabetes/ HTN

4.      Patients with heart blocks/ cardiac disease

Computer based randomisation will be done and the patients will be randomised into either of the groups:

GRP I: 25 cc 0.5% levobupivicaine with 1ug/kg dexmed (volume=26 ml)

GRP II: 25 cc 0.5% levobupivicaine with 2 ug/kg dexmed (volume 26 ml)

All the drug preparations will be made by an anaesthesiologist not involved in the perioperative  management .

All the patients will be premedicated with 0.25 mg alprazolam a night before surgery. On arrival in the operation room, baseline heart rate, blood pressure and oxygen saturation will be recorded. An intravenous line will be secured in the unaffected limb and 10 ml/kg Ringer′s lactate given.

All the patients will receive brachial plexus block through the supraclavicular  perivascular approach ( USG guided) by an experienced anaesthesiologist blinded to the group allocation.

Sensory block will be assessed by the pin prick method. Assessment of sensory block will be done at every 2 minutes after completion of drug injection in the dermatomal areas corresponding to median nerve, radial nerve, ulnar nerve and musculocutaneous nerve till complete sensory blockade. Sensory onset will be considered when there will be a dull sensation to pin prick along the distribution of any of the above-mentioned nerves. Complete sensory block will be considered when there is complete loss of sensation to pin prick.

Sensory block will be graded as-

Grade 0: Sharp pin felt

Grade 1: Analgesia, dull sensation felt

Grade 2: Anaesthesia, no sensation felt.

Assessment of motor block will be carried out by the same observer at every 2 minutes till complete motor blockade after drug injection. Onset of motor blockade will be considered with Grade 1 motor blockade for any of the four nerves. Peak motor block was considered when there will be Grade 2 motor blockade for all the four nerves. Motor block will be determined according to a modified Bromage scale for upper extremities on a 3-point scale. 

Grade 0: Normal motor function

Grade 1: Decreased motor strength

Grade 2: Complete motor block

Motor blockade will be assessed for the 4 nerves as follows:  

1. thumb abduction (radial nerve),

2. thumb adduction (ulnar nerve),

3.  thumb opposition (median nerve),

4. flexion of elbow (musculocutaneous nerve)

 

The block will be considered incomplete when any of the segments supplied by median, radial, ulnar and musculocutaneous nerve will not have analgesia even after 30 min of drug injection. These patients will be supplemented with intravenous fentanyl (1 μg/ kg) and midazolam (0.02 mg/kg). If more than one nerve remains unaffected, it will be considered a failed block. In this case, general anaesthesia will be given intraoperatively.

ASSESSMENT

1.      Patients will be monitored for haemodynamic variables such as heart rate, blood pressure and oxygen saturation every 15 min after the block intraoperatively and every 30 min post-operatively.

2.      Sedation of patient was assessed by the Ramsay Sedation Score every 15 minutes after the block till the end of surgery and every 30 minutes post operatively till 6 hours.

3.      Postoperative pain assessment using visual analogue score every half an hour till  is >4. Once the pain reaches vas>4, Iv paracetamol 15 mg/kg will be administered for rescue analgesia and the time of administration will be noted.

4.      Adverse effects like nausea, vomiting, dryness of mouth and complications like pneumothorax, haematoma, local anaesthetic toxicity and post-block neuropathy in the intra- and post-operative periods.

5.      The duration of sensory block was defined as the time interval between the end of local anaesthetic administration and the complete resolution of anaesthesia on all nerves.

 
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