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CTRI Number  CTRI/2024/05/067005 [Registered on: 08/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of stellate ganglion block with interscalene brachial plexus block for post operative pain relief in patients undergoing surgeries of upper limb  
Scientific Title of Study   Stellate Ganglion Block vs Interscalene Brachial Plexus Block for postoperative analgesia among patients undergoing upper limb surgeries: randomized clinical trial.  
Trial Acronym  NL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abhilash Sharma 
Designation  Junior Resident 
Affiliation  PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive care, 4th floor, A block, Nehru hospital, PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8448763286  
Fax    
Email  abhilash94@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karan Singla 
Designation  Assistant professor  
Affiliation  PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive care, 4th floor, A block, Nehru Hospital PGIMER, Sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9592919073  
Fax    
Email  karansingla16@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karan Singla 
Designation  Assistant professor  
Affiliation  PGIMER Chandigarh 
Address  Department of Anaesthesia and Intensive care, 4th floor, A block , Nehru hospital PGIMER, sector 12, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9592919073  
Fax    
Email  karansingla16@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru Hospital, PGIMER, sector 12, chandigarh, India, 160012 
 
Primary Sponsor  
Name  PGIMER chandigarh  
Address  Department of Anaesthesia and Intensive Care, 4th floor, A block, Nehru hospital, PGIMER, Sector 12, Chandigarh, India. 160012  
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 Karan Singla  Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh   Operation Theatre Complex, 3rd floor, Department of Anaesthesia and Intensive Care, Advanced Trauma Centre, PGIMER, Chandigarh. 160012
Chandigarh
CHANDIGARH 
9592919073

karansingla16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S423||Fracture of shaft of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  interscalene brachial plexus nerve block  patients with upper limb fractures will be administered interscalene brachial plexus nerve block for analgesia. Post-operative pain scores using the Numerical rating Scale will be recorded at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours post operatively.  
Intervention  stellate ganglion block  patients with upper limb fractures will be administered stellate ganglion block for post operative analgesia. patients will be observed for post operative pain at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours post operatively using the Numerical rating Scale  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of ASA physical status 1–2, aged between 18 and 60 years with an upper limb fracture scheduled for surgery under general anaesthesia. We will include patients with humerus shaft fractures, humerus surgical neck fractures and humeral supracondylar fractures, where open surgery is indicated.  
 
ExclusionCriteria 
Details  BMI more than 30 kg/m2, history of substance abuse, Inability to understand a pain scale (VAS, NRS), Allergy to lignocaine , Chronic sympathetic-mediated pain syndromes affecting the upper limb, Trauma other than to the affected limb, Severe congestive heart failure , Severe Chronic obstructive pulmonary disease (COPD)
 
 
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 
To compare the efficacy of preoperative stellate ganglion block with interscalene brachial plexus block among patients undergoing upper limb surgeries as a difference in NRS of 2.   0,6,12,24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the incidence of adverse effects in each of the two groups, To determine time to administration of first rescue analgesic, To find the total dose of tramadol consumption in first 48 hours post operatively
 
0,6,12,24 hours 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   20/05/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Patients will be  evaluated before surgery to assess their fitness for the proposed surgical procedure under general anaesthesia, and written informed consent will be obtained at this stage. Patients will be instructed on the pain NRS scorebefore surgery, and will be  reminded before transfer to the operating theatre and in the post- anaesthesia care unit. All patients will be fasted for 8 h pre-operatively and premedicated with oral alprazolam 0.25 mg and ranitidine 150 mg the night before and 2 h before surgery. In the operating theatre, mandatory monitoring including NIBP (Non-Invasive Blood Pressure), heart rate, continuous ECG, oxygen saturation and end-tidal carbon 

dioxide will be placed. Intravenous access will be established and patients receive 500 ml saline 0.9% and midazolam 1–2 mg. Stellate ganglion block (SGB group) will be  performed under ultrasound guidance using the para-tracheal, out-of-plane technique. Doppler imaging will be  used to rule out any aberrant vessels along the plane of needle placement. Three millilitres of  lignocaine 2% will be injected at the level of the C7 vertebra underneath the fascia of the longus colli muscle. Correct localisation of the injection will be  demonstrated by expansion of the fascia over the muscle. Interscalene block (IBPB group)The block will be performed under sterile conditions. Using a high-frequency linear ultrasound transducer. The cervical roots and interscalene muscles will be  identified. The anaesthesiologist will  insert 22 gauge. 80 mm nerve stimulating needle lateral to medial, with an in-plane technique into the interscalene groove. Once the tip of the needle was positioned in between the C5 and C6 nerve roots,  20 ml of 0.125% bupivacaine would be injected in incremental doses with intermittent aspiration Patients in both groups will be observed for any possible adverse effects of the block such as Horner’s syndrome, motor or sensory blockade of the upper limb, recurrent laryngeal nerve or phrenic nerve block  or any other effects for 10 min before induction of general anaesthesia. 

General anaesthesia was induced with intravenous fentanyl 2 mcg/kg and propofol 2–3 mg/kg, and vecuronium 0.1 mg/kg will be administered to provide muscle paralysis. After tracheal intubation, anaesthesia will be maintained with nitrous oxide:oxygen 60:40 and isoflurane 1–2%, and intermittent boluses of vecuronium will be administered as required. Twenty minutes before the end of surgery, Tramadol 1 mg/kg and ondansetron 0.1 mg/kg will be administered intravenously. At the end of surgery, residual neuromuscular blockade will be reversed with intravenous neostigmine 50 mcg/kg plus glycopyrrolate 10 mcg/kg. 

Routine postoperative analgesia includes intravenous paracetamol 1 g every 6 h and intra- venous diclofenac 75 mg every 12 hourly. Postoperative measurements will be  made at 0, 2, 4, 6, 8, 12 24 and 48 hours postoperatively consisting of pain scores as measured by Numerical Rating scale (NRS) at rest and at movementIf NRS was >4, rescue analgesia in the form of  Tramadol 75 mg IV with ondansetron 4 mg will be administered. At every time point, Tramadol consumption, cardiovascular variables, sedation, nausea, vomiting, and any adverse effects like respiratory failure, hematoma will be recorded.

 
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