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CTRI Number  CTRI/2020/04/024510 [Registered on: 08/04/2020] Trial Registered Prospectively
Last Modified On: 25/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   The effect of good pain relief on arm movement following surgeries for fractures around the elbow  
Scientific Title of Study   Effect of patient controlled continuous infraclavicular block on early functional rehabilitation following surgeries for fractures around the elbow  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arun Jagath A S 
Designation  Junior Resident, Department of Anaesthesia  
Affiliation  PGIMER, Chandigarh  
Address  House number 2114 , sector 15 c , Chandigarh

Chandigarh
CHANDIGARH
160015
India 
Phone  9717828974  
Fax    
Email  jagath9717@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Arun Jagath A S 
Designation  Junior Resident, Department of Anaesthesia  
Affiliation  PGIMER, Chandigarh  
Address  House number 2114 , sector 15 c , Chandigarh

Chandigarh
CHANDIGARH
160015
India 
Phone  9717828974  
Fax    
Email  jagath9717@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nidhi Bhatia 
Designation  Additional Professor  
Affiliation  PGIMER, Chandigarh  
Address  Dept of Anaesthesia and Intensive Care Nehru Hospital PGIMER Sector 12

Chandigarh
CHANDIGARH
160012
India 
Phone  9914207483  
Fax    
Email  nidhi.bhatia75@gmail.com  
 
Source of Monetary or Material Support  
PGIMER, Chandigarh 
 
Primary Sponsor  
Name  PGIMER 
Address  Sector 12, Chandigarh 
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 Arun Jagath AS  PGIMER  Department of Anaesthesia and Intensive Care, PGIMER, Sector 12, Chandigarh
Chandigarh
CHANDIGARH 		 9717828974

jagath9717@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  infraclavicular brachial plexus block Group  patients will receive continuous infraclavicular brachial plexus block using 0.2% Ropivacaine at a basal rate of 5 ml / hr, with a patient controlled bolus of 3ml and a lockout interval of 30 minutes . 
Comparator Agent  Intravenous group  patients will receive intravenous PCA in the postoperative period, using patient controlled bolus of 1mg Morphine intravenously with a lockout interval of 15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  patients scheduled to undergo open reduction, internal fixation surgery for fractures around the elbow, under general anaesthesia will be enrolled in the study.  
 
ExclusionCriteria 
Details  ❖ Local infection at the block site
❖ Brachial plexus injury
❖ Coagulopathy
❖ Sepsis
❖ Obesity (BMI>30)
❖ Allergy to local anesthetics / opioids
❖ Uncontrolled hypertension or ischemic heart disease
❖ Renal or hepatic dysfunction
❖ Bronchopulmonary disorders
❖ Pre-existing neurological deficit
❖ Prior surgery in the infraclavicular area
❖ Psychiatric illness
❖ Inability to cooperate or understand the study protocol.
❖ Patients who fail to understand the scoring systems used in the study
❖ Refusal to give consent for the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mayo Elbow Performance Score   3 weeks following discharge  
 
Secondary Outcome  
Outcome  TimePoints 
1.Mayo Elbow Performance Score at 3 months following discharge from the hospital
2. Numeric rating scale (NRS) score 4 hourly for 72 hours
3. NRS score at the time of physiotherapy
4. Perioperative consumption of bolus doses of opioids and local anaesthetics in the initial 72 hours after surgery

5. Total dosage of rescue analgesic consumed in 72 hours.

6. Time to first dose of rescue analgesia

7. Any complications (including nausea, vomiting, sedation) in the postoperative period.

 		 3 months - mayo elbow performance score
NRS- 4hourly for 72 hours

 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This prospective, randomised clinical trial will be conducted in the department of Anaesthesia and Intensive Care, PGIMER, Chandigarh with the aim of investigating the effect of analgesia via patient controlled continuous infraclavicular brachial plexus block technique, on early functional rehabilitation after surgery for fractures around elbow. Patients will be allocated to one of the two groups of 20 patients each: Group I patients (n=20) will receive intravenous PCA in the postoperative period, using patient controlled bolus of 1mg Morphine intravenously with a lockout interval of 15 minutes.Group II patients (n=20) will receive  continuous infraclavicular brachial plexus block using 0.2% Ropivacaine at a basal rate of 5 ml / hr, with a patient controlled bolus of 3ml and a lockout interval of 30 minutes. All patients will be assessed after 3 weeks and 3 months following discharge. MEPS score will be assessed during these sessions by an assessor who is blinded to the group allocations.

  
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