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CTRI Number  CTRI/2024/11/077160 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 17/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the anaesthetic techniques, shoulder block( nerve block) versus interscalene block(nerve block) that are given in shoulder repair surgeries done under arthroscopy(mininimally invasive procedure) for pain relief after surgery.  
Scientific Title of Study   Effectiveness of Shoulder block versus Interscalene block for Postoperative analgesia in Arthroscopic Shoulder surgeries, A Randomised Controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jacqueline James 
Designation  Post graduate student 
Affiliation  Institute of Medical Sciences and SUM hospital. 
Address  Department of Anaesthesiology and Critical care, first floor, IMS and SUM Hospital, Siksha O Anusandhan, K8, Kalinga Nagar, Bhubaneshwar

Khordha
ORISSA
751003
India 
Phone  9148701075  
Fax    
Email  kukijack13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sulochana Dash  
Designation  Professor  
Affiliation  Institute of medical sciences and Sum hospital bhubaneshwar odisha 
Address  Department of Anaesthesiology 1st floor of Institute of medical sciences and Sum hospital Siksha O Anusandhan University K8 kalinganar bhubaneshwar odisha 751003 India

Khordha
ORISSA
751003
India 
Phone  9566841303  
Fax    
Email  dr.silu76@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sulochana Dash  
Designation  Professor  
Affiliation  Institute of medical sciences and Sum hospital bhubaneshwar odisha 
Address  Department of Anaesthesiology 1st floor of Institute of medical sciences and Sum hospital Siksha O Anusandhan University K8 kalinganar bhubaneshwar odisha 751003 India

Khordha
ORISSA
751003
India 
Phone  9566841303  
Fax    
Email  dr.silu76@gmail.com  
 
Source of Monetary or Material Support  
Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha, Odisha, India, Pin 751003 
 
Primary Sponsor  
Name  Institute of medical sciences and SUM hospital 
Address  K8 kalinganagar bhubaneshwar odisha 751003 India 
Type of Sponsor  Private 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 
Dr Jacqueline James   Institute of Medical Sciences and SUM Hospital, Siksha O Anusandhan  Department of Anaesthesiology, Orthopedics OT in Modular 3 complex, first floor, Institute of medical Sciences and SUM Hospital, Siksha O Anusandhan, Bhubaneswar, Khordha, Odisha, India, Pin 751003
Khordha
ORISSA 
9148701075

kukijack13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IMS and SUM Hospital, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M244||Recurrent dislocation of joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  interscalene block under USG guidance with inj. Ropivacaine 0.375 percent with dexamethasone total 20ml  Patients are positioned supine with neck slightly extended and head turned away from the side to be blocked. After skin sterilization an ultrasound probe is placed at cricoid cartilage over the sternocleidomastoid muscle and moved laterally to identify the carotid artery, jugular vein, and the brachial plexus appearing as a hypoechoic structure between the anterior and middle scalene muscles. Color Doppler confirms the absence of vascular structures.Skin infiltration with 2 mL 2 percent lidocaine,a 22G needle is inserted in plane.Once the needle tip is close to the brachial plexus roots 20 mL of 0.375 percent ropivacaine with 8 mg dexamethasone is injected. Block success is assessed every 5 minutes until readiness for surgery.Using a 3-point scale, sensory block is assessed by pinprick tests over C5 deltoid, C6 thumb tip,C7 at the middle fingertip as 0 no block, 1 partial, 2 complete absence of sensation.Motor block is assessed by shoulder abduction and elbow flexion: 0 is no block, 1 is partial block, inability to move against resistance, and 2 complete loss of motor power.Patients with complete block failure at 30 minutes are excluded. Immediate complications paresthesia or Horner’s syndrome will be monitored. After the block general anesthesia is administered and anesthesia is maintained with air, oxygen 1 is to 1 isoflurane,and cisatracurium.Additional fentanyl is given if hemodynamic parameters exceed 20 percent of baseline. Neuromuscular blockade is reversed with neostigmine 0.05 mg per kg and glycopyrrolate 0.01 mg per kg post-surgery. Postoperative analgesia is assessed using VAS scoring that is 0 no pain to 10 worst pain at 0, 3, 5, 10, 15, and 24 hours.Rescue analgesia includes paracetamol 1g IV administered on demand or if VAS is more than or equal to 4, or tramadol 50mg as needed.The time to first rescue analgesia and total analgesia required will be recorded.Patient satisfaction rated at 24th hour as excellent,good,fair,poor. 
Intervention  Shoulder block under USG guidance with inj. Ropivacaine 0.375 percent with dexamethasone total 20ml  The suprascapular nerve block will be performed with the patient sitting, arm flexed at the elbow and resting on the thigh. After skin sterilization, a linear ultrasound (USG) probe is placed at the superior medial border of scapula in sagittal plane and moved laterally parallel to scapular spine to identify the scapular fossa where the supraspinatus muscle and the bony fossa under it and suprascapular notch where the suprascapular nerve as a round hypoechoic structure about 4cm in depth behind the transverse scapular ligament. A 22G needle is inserted in-plane with the probe into the suprascapular notch, confirmed by color Doppler the absence of vascular structure, 10 mL of 0.375percent ropivacaine is injected while aspirating every 3 mL to prevent intravascular injection. The axillary nerve block is then performed with the patient still sitting, shoulder adducted and internally rotated, and elbow flexed at 90 degrees. The probe is placed parallel to the humerus below the posterolateral part of acromion to identify the circumflex artery and locate the axillary nerve cranial to it between the teres minor muscle superiorly, deltoid muscle posteriorly, triceps muscle caudally, and shaft of humerus anteriorly. A 22G needle is inserted and remaining 10 mL of 0.375percent ropivacaine is injected slowly. Success of the sensory block will be assessed after 30 minutes using a 3-point scale for both sensory over lateral aspect shoulder regimental badge area 0 no block, 1partial, 2complete and motor function by restriction of shoulder abduction and external rotation as 0 normal movement, 1 partial block, 2 complete loss. Patients with complete block failure at 30 minutes will be excluded, and immediate complications such as paraesthesia or Horner’s syndrome will be monitored. After the blocks general anesthesia will be induced with midazolam and glycopyrrolate followed by propofol 2.0 mg per kg), fentanyl 2 mcg per kg and cisatracurium 0.2 mg per kg for intubation. Anesthesia will be maintained with air and oxygen 1is to1, isoflurane 1percent, and cisatracurium. Additional fentanyl 2 mcg per kg will be given intraoperatively if hemodynamic parameters exceed 20 percent of baseline and neuromuscular blockade will be reversed with neostigmine 0.05 mg per kg and glycopyrrolate 0.01 mg per kg at the end of surgery. Postoperative analgesia will be assessed using VAS scoring that is 0 no pain to 10worst pain at 0,3,5,10,15,24 hours. Rescue analgesia Inj. paracetamol 1 g IV will be administered on demand or if VAS will be more than equal to 4 Inj. tramadol 50 mg will be administered having inadequate pain relief as secondary rescue analgesic. Time of first rescue analgesia the time from operating room discharge until the first dose of rescue analgesia) and total analgesia required number of times analgesic rescue doses will be noted. Satisfaction in terms of overall quality of pain relief rated by the patient at the end of 24h as excellent, good, fair, and poor. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing elective shoulder surgeries
2.Patient within the age group of 18-60 years
3.Patients under ASA I and II
 
 
ExclusionCriteria 
Details  1.Patients under ASA III, ASA IV.
2.Patients with coagulation disorders
3.Patient known allergic to local anesthetic agents
4.Skin infection at local sites
5.Patients who are not willing to participate.
6.Any patient with neurological disorder
7.Chronic obstructive pulmonary disease or any respiratory disease
8.Myopathy and peripheral neuropathie
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1)To Compare the duration of analgesia between shoulder block and interscalene block (Time of requirement of 1st dose of rescue analgesic)

 
1)using visual analogue scale(VAS score that is 0 no pain to 10 worst pain at 0, 3, 5, 10, 15 and 24hours postoperatively
 
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of motor and sensory blockade.

2)Total number of doses of rescue analgesics needed

3)Patient satisfaction score

4)Complications, if any (dyspnea, Horner’s syndrome, pneumothorax, hematoma)
 
1)Block success will be assessed every 5 min from the end of the block given untill general anaesthesia is given

2)Total number of doses of analgesics required over 24hrs

3)Patient satisfaction score at 24th hr as excellent good fair poor 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 4 
Date of First Enrollment (India)   10/12/2024 
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="0"
Months="6"
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  

After the institutional ethics committee approval, this prospective randomised controlled trial will be conducted in 7American Society of Anesthesiologists (ASA) grades 1 and 2, adult (18–60 years) patients of either sex, undergoing elective unilateral arthroscopic shoulder surgery under general anaesthesia.

All patients will undergo a detailed pre-anaesthetic(PAC) check-up and will be fasting after midnight, a written informed consent will be taken for the procedure .An intravenous (IV) access will be secured using 18-G  IVcannula on the opposite hand and Ringer lactate solution will be started.Standard monitors will be attached in the form of five-lead ECG, noninvasive blood pressure monitor, pulse oximeter, and capnograph. The patients will be instructed before hand about how to use visual analogue scale (VAS) for pain postoperatively. The Interscalene block( ISB) and Shoulder block( ShB) will be performed 30 min before induction of General Anesthesia under ultrasound guidance

The procedural duration of the blocks is defined as the time that block needle will beunder the skin. The procedure will be performed by experienced who has performed at least 100 blocks.Preoperative measurements (baseline vital parameters, procedural duration, pain on injection, sensory and motor block) will be noted by this person and handed over to the investigators. The patients will be randomly allocated into 2 groups of 37 each using block randomisation technique and investigator assessing the  postoperative outcomes will be blinded to the group allocation and to the procedure and  allocation concealment will be achieved using opaque sealed envelope technique

All patient will be tested for local anesthesia skin test before the start of the procedure.Group ShB(shoulder block group,n = 37) will be given 20 ml of 0.375% Ropivacaine with 8mg Dexamethasone  that is 10ml  each for SSN (suprascapular nerve)and AN(axillary nerve) block and Group ISB(interscalene block group,n = 37) will be given 20 ml 0.375% Ropivacaine with 8mg Dexamethasone.

For performing Interscalene blockthe patients will be positioned supine with neck slightly extended and the head turned away from the side to be blocked. The skin of the neck will be sterilized and the ultrasound probe will be placed at the level of the cricoid cartilage over the Sternomastoid muscle and moved laterally to identify the carotid artery, jugular vein and then laterally and posteriorly until visualization of the Brachial plexus as hypoechoic nerve structure between the anterior and middle scalene muscle. Confirmation of absence of vascular structure will be made by colour Doppler. After skin infltration with 2 ml of lidocaine 2% a 22-G will be insertedin plane with the probe to visualize the entire needle length. When the needle tip will be seen close to the Brachial plexus roots, an assistant will start to inject the local anesthetic (20 ml 0.375% Ropivacaine with 8mg dexamethasone) with aspiration every 5 ml to avoid intravascular injection and the local anesthetic spread will beobserved. 

Block success will be assessed every 5 min from the end of local anesthetic injection until readiness for surgery. Sensory block will be assessed over C5–C7 dermatomesand by pinprick using 22-G needles over the lateral side of the forearm and thumb(C5 – skin over deltoid, C6 – thumb tip, C7 – middle fingertip) this will be assessed on 3 point scale (0 = no block/ normal sensation; 1 = partial; a touch of pinprick but no pain; and 2 = complete; absence of sensation to pinprick) . Motor block will beassessed by restriction of shoulder abduction and elbow flexion based on 3 point scale (0 = no block; normal movements of the shoulder, arm, and forearm, 1 = partial block; inability to perform movements against resistance and 2 = complete loss of motor power)The block will be considered a failure if the block will be not successful 30 min after injection of the local anesthetic

Suprascapular nerve block will be performed with the patient sitting and his arm flexed at the elbow and resting on his anterior thigh. After skin sterilization, a linear ultrasound probe is placed in a sagittal plane at the superior medial border of the scapula. The probe is moved laterally and then placed parallel to the scapular spine. It is then tilted cephaled to identify the scapular fossa where the supraspinatus muscle and the bony fossa under it can be visualized. Then by moving the transducer slowly laterally, the suprascapular notch can be identifiedwhere the suprascapular nerve can be seen as a round hypoechoic structure about 4cm in depth behind the transverse scapular ligament. 2ml of 2% lidocaine will beused to anesthetize the skin, and then a 22-G  nerve block needle  will be inserted in plane with the ultrasound probe. When the needle tip will be seen in the suprascapular notch and after confirmation of absence of vascular structure by colorDoppler,10 ml of 0.375% Ropivacaine will be injected with aspiration every 3 ml to avoid intravascular injection and the spread of the local anesthetic will be observed.

Axillary nerve block, this will be performed while the patient will be still in the sitting position with the shoulder adducted and internal rotation at 45°, the elbow flexed at 90°and the hand resting on the knee. The probe will be placed parallel to the shaft of the humerus about 2 cm below the posterolateral part of the acromion on the dorsal side of the arm. The surgical neck of the humerus will be identified then a short-axis view of the circumflex artery (which is the most reliable land markwill be visualized. The axillary nerve is located just cranial to the circumflex artery in the neurovascular space between the teres minor muscle superiorly, the deltoid muscle posteriorly, the triceps muscle caudally, and the shaft of the humerus anteriorly. A 22-G needle will be inserted in line with the ultrasound probe from its cranial end to place the needle tip just cranial to the circumflex artery under the muscle fascia. Then remaining10ml of 0.375% ropivacaine will be injected slowly while aspirating every 3ml to avoid intravascular injection.

Success of sensory block in shoulder block will be assessed after 30 min, on a 3-point scale. The sensory block will be assessed over lateral aspect shoulder (regimental badge area, supplied by the AN) and Motor block by restriction of shoulder abduction and external rotation . Patients with complete block failure at 30 min will be excluded. Immediate complications, such as paraesthesia, Horner’s syndrome, respiratory distress etc. will be assessed.

After the blockade, all patients will receive General anesthesia using premedicationsMidazolam and  glycopyrrolate and will be induced with inj propofol 2.0 mg/kg, fentanyl 2 Î¼g/kg, and cisatracurium 0.2 mg/kg after adequate relaxation  insertion of endotracheal tube insertion will be done, and controlled ventilation is started. Anesthesia will be maintained with Air and oxygen at a ratio of 1:1 and , isoflurane 1%, and 0.03 mg/kg cisatracuriumAdditional analgesia inj fentanyl (2 µg/kg)will be given intraoperatively if hemodynamic parameters are exceeding 20% of the baseline value. At the end of surgery, anesthesia will be stopped and neuromuscular blockade will be reversed with 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate.

Postoperative analgesia will be assessed using VAS(Visual analogue scale) scoring that is  0=no pain to 10=worst pain at 0,3,5,10,15,24 hours . Rescue analgesia in the form of Inj. paracetamol 1 g IV will be administered on demand or if VAS will be ≥ 4 (maximum 4 doses, 6 h apart). Inj. tramadol 50 mg will be administered to patients having inadequate pain relief after  paracetamol infusion as secondary rescue analgesic. Time of first rescue analgesia (the time from operating room discharge until the first dose of rescue analgesia) and total analgesia required (number of times analgesic rescue doses) will be noted. Satisfaction in terms of overall quality of pain relief will be rated by the patient at the end of 24 h as excellent, good, fair, and poor.

The categorical data will be expressed as numbers (percentages) while continuous data will be presented as mean ± standard deviation (SD) and median values. The data normality will be checked by using the Kolmogorov–Smirnov test. The comparison of the variables, which will be quantitative and normally distributed, will be analysed using unpaired t-test Comparison of VAS score between 2 groups will be done by  Mann Whitney. The comparison of qualitative variables  will be  analysed using Chi-square test/Fisher’s exact test. The statistically significant difference is considered as a P value <0.05. Sample size was estimated on the basis of previous study Suman Saini et al in which Mean difference of two groups and taking 80% study power and an type 1 error of 0.05.To allow for study error and attrition, 37 patients were included in each group

 

 
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