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CTRI Number  CTRI/2015/10/006321 [Registered on: 28/10/2015] Trial Registered Retrospectively
Last Modified On: 27/10/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   CLONIDINE AS AN ADJUVANT TO ROPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK  
Scientific Title of Study   CLINICAL EVALUATION OF CLONIDINE AS AN ADJUVANT TO ROPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERY : A PROSPECTIVE, RANDOMISED, DOUBLE BLIND, 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  DrVatsal Zanzmera 
Designation  Resident Doctor 
Affiliation   
Address  Department of Anaesthesiology, Sir T. General Hospital, Kalubha Road, Bhavnagar-364001
101, Devganiya Complex, Ashanagar Society, Singanpoor Road, Katargam, Surat,Gujarat, India.
Bhavnagar
GUJARAT
364001
India 
Phone  9601291762  
Fax    
Email  vatsal.zanzmera@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKomal S Shah 
Designation  Associate Professor (PG Guide) 
Affiliation   
Address  Plot no.13, “MANUSMRUTI” Opposite Shiv- Park Society AnantwadI, Bhavnagar- 364001

Bhavnagar
GUJARAT
364001
India 
Phone  9427215252  
Fax    
Email  Shah.komal@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  DrVatsal Zanzmera 
Designation  Resident Doctor 
Affiliation   
Address  Department of Anaesthesiology, Sir T. General Hospital, Kalubha Road, Bhavnagar-364001

Bhavnagar
GUJARAT
364001
India 
Phone  9601291762  
Fax    
Email  vatsal.zanzmera@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY, GOVERNMENT MEDICAL COLLEGE AND SIR T. HOSPITAL, BHAVNAGAR-364001 
 
Primary Sponsor  
Name  Government Medical College Bhavnagar 
Address  Behind S.T. Stand, Jail Road, Bhavnagar 364001 (Gujarat) India 
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 
DrVatsal Zanzmera  GOVERNMENT MEDICAL COLLEGE AND SIR T. HOSPITAL, BHAVNAGAR  Behind S.T. Stand, Jail Road, Bhavnagar 364001 (Gujarat) India
Bhavnagar
GUJARAT 
9601291762

vatsal.zanzmera@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD (HUMAN ETHICS COMMITTEE)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  PATIENTS PLANNED FOR UPPER LIMB ORTHOPEDIC SURGERY,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INJECTION CLONIDINE AS AN ADJUVANT TO ROPIVACAINE  INJECTION CLONIDINE 90 MICROGRAM IS ADDED AS AN ADJUVANT TO ROPIVACAINE (0.5%) 30 CC AND SOLUTION IS GIVEN IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK USING NERVE LOCATOR FOR PATIETS OF UPPER LIMB ORTHOPEDIC SURGERY 
Comparator Agent  ROPIVACAINE WITH NORMAL SALINE  NORMAL SALINE 0.6 CC ADDED IN ROPIVACAINE (0.5%) 30 CC AND SOLUTION IS GIVEN IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK USING NERVE LOCATOR FOR PATIETS OF UPPER LIMB ORTHOPEDIC SURGERY 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Inclusion Criteria
• Age: 20 to 60 years.
• Gender: Either gender.
• Patients scheduled for elective upper limb orthopedic surgery
• ASA physical status II and I.
• BMI ≤ 25kg/m2.
• Informed written consent for participation in study.
 
 
ExclusionCriteria 
Details  Exclusion Criteria
• Patients refusing consent.
• Contraindications to regional anesthesia.
• Previous nerve injury.
• History of drug dependence/abuse.
• History of drug allergy.
• Patients taking analgesics and sedatives.
• Patients on anticoagulants.
• History of bleeding disorders.
• Any major systemic illness.
• Antenatal females.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
SENSORY AND MOTOTR CHARECTERISTICS- ONSET, PEAK, DURATION
 
End of the injection was taken as Time 0. Immediately after the block, sensory and motor characteristics of blockade were assessed at 1, 3, 5, 10, 15, 30 minutes and then at hourly interval till offset of sensory and motor blockade and then at two hourly interval for 24 hours.
 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of effective post-operative analgesia.
Total dose and frequency of rescue analgesics required in 24 hours
 
UP TO 24 HOURS AFTER GIVING BLOCK 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2014 
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="2"
Days="22" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Background and Objectives:

To evaluate the efficacy and safety of Clonidine as an adjuvant to Ropivacaine in supraclavicular brachial plexus blockade in respect to,

1.     Onset, peak and duration of sensory blockade.

2.     Onset, peak and duration of motor blockade.

3.     Duration of effective post-operative analgesia.

4.     Total dose and frequency of rescue analgesics required in 24 hours.

5.     Sedation score.

6.     Effects on hemodynamic variables- Heart Rate (HR), Mean Arterial Blood pressure (MAP) and peripheral oxygen saturation (SpO2).

7.     Complications if any.

Methods:

After Approval from Institutional review board and informed written consent from the patients, this prospective, randomized, double blind controlled clinical study was carried out in 120 patients of ASA physical status I and II, aged 20 – 60 years of either sex scheduled for upper limb orthopedic surgeries.

Patients were randomized to one of the two groups by sealed envelope method.

Group R (n = 60) – Ropivacaine 0.5% 30 cc + 0.6 cc normal saline

Group RC (n =60) –Ropivacaine 0.5%30 cc + 0.6 cc (90 μg) clonidine  

           Monitoring consisting of heart rate, mean arterial blood pressure and peripheral oxygen saturation was established and baseline vital parameters were recorded.

           After securing intravenous line, supraclavicular brachial plexus block was performed with the aid of nerve locator. Patients were observed for onset, peak and duration of sensory and motor brachial plexus blockade. Changes in visual analogue score (VAS) were noted and the first rescue analgesic was injected when VAS exceeded 5. The time for first rescue analgesic required and the total number of rescue analgesic doses injected in 24 hours was also noted in both the groups.

          Changes in HR, BP, Sedation Score and SpO2 were also recorded as per the specified time.

Results:

          Mean time of onset of sensory blockade was 11.36±2.42 min and 9.84±1.58 min respectively in groups R and RC. Henceforth, the onset of sensory blockade was significantly earlier in group RC as compared to group R. (p=0.0001)  

          Mean time to achieve peak of sensory blockade was 18.18±3.47 and 13.78±1.94 minutes respectively in group R and RC. Henceforth, the time to achieve peak of sensory blockade was significantly earlier in group RC as compared to group R. (P<0.0001)

Mean duration of sensory blockade was 477.00±29.77 and 678.42±104.07 minutes respectively in groups R and RC. Henceforth, the duration of    sensory blockade was significantly prolonged in group RC as compared to group R. (P<0.0001)

           The duration of analgesia was prolonged with addition of clonidine to ropivacaine. Mean duration of analgesia was 584.6±34.41 and 801±80.46 minutes respectively in groups R and RC. Henceforth, the duration of analgesia was significantly prolonged in group RC as compared to group R. (P<0.0001)

           In group R, majority of patients needed minimum of two analgesic doses during 24 hour study period while in group RC, majority of patients needed only one analgesic dose.

           Hence, clonidine as an adjuvant to ropivacaine provided significantly earlier onset and peak and prolonged duration of sensory blockade and analgesia as compared to control group.

            Similar findings were noted for motor characteristics of supraclavicular brachial blockade in the present study. Mean time of onset was16.26±3.80 and 14.5±2.36 min respectively in group R and group RC (p=0.0094), peak was 37.56±3.03 and 22.85±3.94 min respectively in group R and group RC (p<0.0001) and duration of motor blockade was 417.20±35.343 and 547.80±34.184 min respectively in group R and group RC which was statistically significant. (P<0.0001) Henceforth, the onset and peak of motor blockade was significantly earlier and duration was significantly prolonged in groups RC as compared to group R.

            Hence, clonidine as an adjuvant to ropivacaine provided significantly earlier onset and peak and prolonged duration of motor blockade as compared to control group.

           In this study, sedation score was higher in group RC (score 2) as compared to group R (score 0) without any adverse consequences. (P<0.05)

           On comparison of hemodynamics amongst the two groups, there was statistically significant decrease in HR and BP in group RC as compared to group R. Two patients developed bradycardia in group RC, which responded to Inj.atropine and was not clinically significant.

            SpO2 remained stable and comparable in both groups throughout the study period. (P>0.05)

Except bradycardia (3% in group RC), no other complication was observed in two groups.

Conclusion:

From this study, it is concluded that addition of 90 μg of clonidine to ropivacaine in supraclavicular brachial plexus blockade is safe and effective in improving the quality of blockade, prolongs the duration and provides effective analgesia with adequate sedation well extending into the postoperative period without any adverse events. 
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