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CTRI Number  CTRI/2019/05/018960 [Registered on: 06/05/2019] Trial Registered Prospectively
Last Modified On: 02/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Study the effect of Dexamethasone as adjuvant to regional block of upper extremity surgery. 
Scientific Title of Study   Efficacy of systemic or perineural Dexamethasone as adjuvant to ultrasound guided supraclavicular block. 
Trial Acronym  D-SCBPB 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohanhariraj Angamuthammal 
Designation  Senior Assistant Professor 
Affiliation  Government Mohan Kumaramangalam Medical College, Salem  
Address  Senior Assistant Professor,Department of Anaesthesiology, Govt Mohan Kumaramangalam Medical College Hospital, Salem.
B2, MKN Arcade, Maravaneri Fifth Cross, Salem -7
Salem
TAMIL NADU
636001
India 
Phone  9994740519  
Fax    
Email  mohanhariraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohanhariraj Angamuthammal 
Designation  Senior Assistant Professor 
Affiliation  Government Mohan Kumaramangalam Medical College, Salem  
Address  Senior Assistant Professor,Department of Anaesthesiology, Govt Mohan Kumaramangalam Medical College Hospital, Salem.
B2, MKN Arcade, Maravaneri Fifth Cross, Salem -7
Salem
TAMIL NADU
636001
India 
Phone  9994740519  
Fax    
Email  mohanhariraj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manivannan Pachiappan 
Designation  Junior Resident 
Affiliation  Government Mohan Kumaramangalam Medical College, Salem  
Address  Department of Anaesthesiology, Govt Mohan Kumaramangalam Medical College Hospital, Salem.
97/85, Pallakadu,Amaragundhi post, Omalur Taluk, Salem 636503.
Salem
TAMIL NADU
636001
India 
Phone  9629262684  
Fax    
Email  manivannan.p1986@gmail.com  
 
Source of Monetary or Material Support  
The Dean, Government Mohan Kumaramangalam Medical College and Hospital, Salem 636001 
 
Primary Sponsor  
Name  Manivannan Pachiappan 
Address  Government Mohan Kumaramangalam Medical College and Hospital, Salem. 
Type of Sponsor  Other [] 
 
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 Mohanhariraj Angamuthammal  Government Mohan Kumaramangalam Medical college and Hospital  Department of Orthopedics, Ortho OT complex.Government Mohan Kumaramangalam Medical college,salem 636001
Salem
TAMIL NADU 
9994740519

mohanhariraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Mohan Kumaramangalam Medical College, Salem   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intravenous versus Perineural Dexamethasone  Compare the efficacy of systemic or perineural Dexamethasone as an adjunct to ultrasound guided Supraclavicular block in Three groups 
Intervention  To compare the efficacy of systemic or perineural Dexamethasone as an adjunct to ultrasound guided supraclavicular block  1.Onset of sensory block and motor block 2.Duration of sensory and motor block 3.Postoperative pain and analgesic requirements 4.Postoperative patients satisfaction 5.aObservation of complications if any  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients Posted for Upper extremity elective surgery
2. American Society of Anesthesiologists physical status class I-II
4. Age group : 18-60 years
5. BMI < 35 kg/m2
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Pregnancy
3. Surgical procedure duration of 180 minutes or longer
4. Severe respiratory disease
5. Chest or shoulder deformities operating side
6. Preexisting neurological deficit or neuropathy
7. Allergy to local anesthetics or dexamethasone
8. Local skin infection
9. Coagulopathy, Bleeding diathesis

 
 
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 
Onset, peak and Duration of sensory block   Sensory block will be assessed every 5mins upto 30 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Onset, Peak and Duration of motor block
2. Cumulative Postoperative analgesic usage in first 24 hours
3. 24th hour VAS
4. Recording of complications if any (nausea, vomiting, bleeding, technical failure…..)
 
motor block will be assessed every 5mins up to 30 minutes
 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   10/05/2019 
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)  Not Yet Recruiting 
Publication Details   1. Faraj W. Abdallah, MD, Intravenous Dexamethasone and Perineural Dexamethasone Similarly Prolong the Duration of Analgesia After Supraclavicular Brachial Plexus Block A Randomized, Triple-Arm, Double-Blind, Placebo-Controlled Trial Regional Anesthesia and Pain Medicine. Volume 40, Number 2, March-April 2015 2. Abdallah FW, Brull R. The facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve blockade: a systematic review and meta-analysis. Br J Anaesth. 2013 3. Choi S, Rodseth R, mccartney CJ. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth. 2014  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Supraclavicular brachial plexus block is the most consistent block for upper limb surgeries.

Local anesthetics alone provides analgesia for only 4-8 hrs. Various additives like Opioids , Clonidine etc. prolong analgesia. Steroids have powerful anti inflammatory as well as analgesic property.

Steriods relieve pain by reducing inflammation, blocking transmission of nociceptive C-fibres and by suppressing ectopic neural discharge.Systemic or perineural administration of steroids enhances efficacy of brachial plexus block. There is Paucity of study of dexamethasone as adjunt for plexus blocks in Indian population. Hence Influence of dexamethasone as a systemic or perineural additive to plexus blockade needs to be evaluated

 

Aim:

      To compare efficacy of systemic or perineural dexamethasone as an adjunct to ultrasound guided supraclavicular block

Objectives:

To compare the efficacy of Systemic or Perineural Dexamethasone as an adjunct to ultrasound guided Supraclavicular block in terms of

1.    Onset of sensory block and motor blockade

2.    Peak effect of sensory block and motor blockade

3.    Duration of sensory block and motor blockade

4.    Postoperative pain and analgesic requirement

5.    Postoperative patient satisfaction

6.    Observation of complications if any

 

Trial Design

       Prospective

       Interventional

       Parallel, Triple arm

       Randomized, active controlled

       Triple Blinded

       Single centre

 

Materials

       LOGIQ- e: Ultrasound machine and High frequency Linear Transducer (12MHZ) to scan the block area

          (Wipro GE Healthcare Pvt. Ltd., India)

       80mm 22G Sonoplex STIM needles to perform block

  (Pajunk GmbH, Germany – Hospimedica International Ltd)

Drugs

1.Inj. Bupivacaine 0.5% plain 20ml vial

   (Nandani Medical Laboratories Pvt. Ltd.) (TN Govt. Supply)

2.Inj. Dexamethasone IV 2ml vial (4mg/ml)

   (Alves Healthcare Pvt. Ltd.) (Tn Govt. Supply)

 

Methodology

Sample size 90 with 30 in each group, Computer generated randomization, allocation concealment by SNOOSE technique,

GROUP

A

B

C

Block drug

24ml of 0.5% bupivacaine + 6ml distilled water

24ml of 0.5% bupivacaine + 6ml distilled water

24ml of 0.5% bupivacaine + 4ml distilled water + 2ml (8mg) of Dexamethasone

IV drug

10ml saline

10 ml (8ml saline + 2ml (8mg ) of  Dexamethasone)

10ml saline

Procedure

After shifting the patient to the operating room, baseline monitors will be connected

       All subjects will receive

       Supplemental oxygen 6L/min via face mask

       Procedural sedation with midazolam 0.03 mg/kg and fentanyl 1 microgram/kg

       Performers will administer Supraclavicular brachial plexus block under ultrasound guidance using 22 gauge, 80mm short bevel needle with 30 ml block drug along with intravenous injection of  10 ml of IV drug both prepared by research assistant.

       After completion of block the primary researcher or secondary researcher will measure and record the following outcomes

Primary Outcome:

       Onset, Peak and Duration of sensory block

Secondary Outcomes:

       Onset, Peak and Duration of motor block

       Cumulative Postoperative analgesic usage in first 24 hours

       24th hour VAS

       Recording of complications if any (nausea, vomiting, bleeding, technical failure…..)

       Sensory block will be assessed every 5 minutes up to 30 minutes (0, 5, 10, 15, 20, 25, 30 mins)

 
 NerveArea Assessed 
 Median Volar aspect of thumb
 Radial lateral aspect of dorsum of hand
 Ulnar volar aspect of fifth finger
 Musculocutaneous Nerve lateral aspect of forearm

       The extent of sensory block will be assessed by testing for pin prick with blunted 24G hypodermic needle in the median, radial, ulnar, and musculocutaneous nerve distributions using -3-point score:

 Score Sensations
 0 normal sensation
 1 dull sensation to pin prick
 2 no sensation to pin prick
 

       Onset time is defined as time to dull sensation along any of the nerve distribution after block completion

       Peak effect is time to achieve complete loss of sensation along all the four nerve distribution after block completion (score ≥ 7)

       Motor block will be assessed every 5 minutes up to 30 minutes

   (0, 5, 10, 15, 20, 25, 30 mins)

 Nerve Movement Assessed
 Median Thumb opposition
 Radial Thumb Abduction
 Ulnar Thumb Adduction
 Musculo-cutaneous Nerve Elbow flexion in Supination and Pronation

 

       The extent of motor block will also be tested in the distribution of the median radial, ulnar and musculocutaneous nerves using -3-point scale,

 ScoreMotor movements 
 0 Normal Movement
 1 Paresis
 2 No Movement

       Onset time is considered when patient felt heaviness on abduction of arm at shoulder

       Peak effect time is considered when patient was unable to perform any of the movement as defined for each individual nerve (score ≥ 7)

       Cumulative score of 14 and above in 30 minutes is considered as block success.  Score less than 14 will be recorded as block failure and will be excluded from analysis

       Duration of analgesia is the time between sensory onset and time when patient feels pain

       Duration of motor block is time between motor onset and time when patient flexes and extends the elbow and wrist with normal power

       All Patients will receive oral paracetamol 500mg every six hours as baseline postop analgesia for 24 hours

       Inj. Tramadol 100 mg will be given intramuscularly if Visual analogue scale [VAS] ≥4) during the postop period.

       The cumulative requirement of opioid during first 24 hours will be recorded.

       Other complications if any will be recorded

 

 
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