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CTRI Number  CTRI/2020/06/026246 [Registered on: 30/06/2020] Trial Registered Prospectively
Last Modified On: 24/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effects of differences in the way injections are given in the back of spine and the direction with which the needle face on the duration of pain relief to the patients undergoing surgeries on bones of leg 
Scientific Title of Study   A double blinded randomized control trial of the effects pf differences in epidural needle entry point and angle of rotation of needle hub on the duration of sensory blockade in lower limb orthopaedic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Annushha Gayathri G 
Designation  Post Graduate Student 
Affiliation  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  Room no 16 B C Roy Hostel SRM Medical College Hospital and Research Centre Department of Anaesthesiology SRMIST Potheri Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  8939064666  
Fax    
Email  annu.gayu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Annushha Gayathri G 
Designation  Post Graduate Student 
Affiliation  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  Room no 16 B C Roy Hostel SRM Medical College Hospital and Research Centre Department of Anaesthesiology SRMIST Potheri Kancheepuram TAMIL NADU 603203 India

Kancheepuram
TAMIL NADU
603203
India 
Phone  8939064666  
Fax    
Email  annu.gayu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R BALAJI 
Designation  Associate Professor 
Affiliation  SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE 
Address  Department of Anaesthesiology SRM Medical College Hospital and Research Centre SRMIST Potheri Kancheepuram TAMILNADU 603203

Kancheepuram
TAMIL NADU
603203
India 
Phone  9677053310  
Fax    
Email  aarbee79@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical College Hospital and Research Centre, SRMIST, SRM nagar, Potheri, Kattankulathur, Kancheepuram district 603203  
 
Primary Sponsor  
Name  SRM Medical College Hospital and Research Centre 
Address  SRMIST SRM nagar Potheri 
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 Annushha Gayathri G  SRM Medical College and Hospital  Room no 16 B C Roy Hostel Department of Anaesthesiology SRM Medical College and Hospital SRMIST Potheri Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 		 8939064666

annu.gayu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical College Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M232||Derangement of meniscus due to oldtear or injury, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Midline Approach  Epidural needle will enter the midline of the spine and the tip will be placed in the usual cephalad direction i.e. 90 degrees and then the catheter will be inserted 
Intervention  Paramedian Approach  Epidural needle will enter the paramedian point(L4-L5 space) and on reaching the epidural space, the tip will be rotated 45 degrees towards the operating side The catheter will be inserted thereafter 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients assessed under ASA I & II
All consenting patients posted for lower limb orthopaedic surgeries
 
 
ExclusionCriteria 
Details  1)Patients with contraindication to central neuraxial blockade
2)Patients with known h/o allergy to local anesthetics
3)Patients with previous h/o spine surgeries 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of sensory block  The evolution of sensory block on both sides will be observed every 5 min till the maximum sensory level is attained and observed for regression of level till the end of surgery- 24 hours post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
1)Onset of sensory blockade
2)Onset and duration of motor blockade
3)Intra operative hemodynamic changes
4)Total volume of local anesthetic given epidurally in post operative period 		 From the start of surgery till 24 hours post operative period 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/07/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   70 patients who meet the Inclusion criteria will be randomly allocated into 2 groups of 35 each(Control group or Rotation group).Monitors (non-invasive arterial blood pressure, pulse oximetry and electrocardiography) will be attached for all patients upon arrival to the operating room.
 Each patient will receive 500 ml of 0.9% NS intravenously before initiating the block procedure. Patients will be then placed in the sitting position. After sterilization and preparation of the site, the skin will be anesthetized by subcutaneous injection of 3ml 2% lidocaine.
An experienced Anesthesiologist will perform the procedure. An 18-gauge,3.5 inch, Tuohy needle will be inserted at the level of L4-5 intervertebral space and pushed forward till the epidural space is attained by the loss-of-resistance technique. Confirmation of the catheter tip position will be done using C Arm
 In control group (midline approach) the needle will enter the midline of the spine and the tip will be placed in the usual cephalad direction i.e. 90 degrees and then the catheter will be inserted.
 For the rotation group (paramedian approach), the needle will enter the paramedian point and on reaching the epidural space, the tip will be rotated 45 degrees towards the operating side. The catheter will be inserted thereafter.
After the catheter gets inserted 5 cm, the needle will be removed, and the catheter will be secured to the skin. A test dose of 3 ml of Inj.Lignocaine 2% with 1:2,00,000 adrenaline will be injected  
The method of securing the catheter with plasters against the patient’s back will be uniform between the groups. Patients will be placed in supine position following which 12 mL of bupivacaine 0.5% will be injected epidurally

The evolution of sensory and motor blocks on both sides will be observed every 5 min till the maximum sensory level is attained. The sensory block level will be evaluated based on pinprick test. Motor block level will be evaluated using Bromage Scale. Readiness for surgery was defined as complete loss of pinprick sensation up to T10 with a Bromage scale of 3 on the surgical side.
Hemodynamic parameters (HR, MAP, and SPO2) will be recorded at baseline and then every 5 minutes during the first 30 min of the operation and subsequently at 15 min intervals until the end of surgery. Complications (hypotension, bradycardia) will be recorded in case of happening and will be managed according to the protocol.
Hypotension will be considered significant if decrease in the systolic arterial blood pressure ≥30% from the baseline, and will be treated with intravenous (IV) crystalloid infusion. If volume expansion was not effective, Inj Ephedrine 6mg IV will be administered. Bradycardia (≥30% decrease from the baseline) will be managed with Inj. Atropine 0.6mg IV. At the end of surgery, patients will be transferred to PACU for epidural infusion and total volume of local anesthetic injected epidurally up to 24 hrs in the post-operative period will be recorded.
 Inadequate surgical anaesthesia will be documented as a failure and the patient will be subjected to General anesthesia
BROMAGE SCALE
SCORE 0 (none) – Full flexion of knees and feet
1(partial)-Just able to move knees
2(almost complete)-Able to move feet only
3 (complete)- Unable to move feet or knees
After regression of the sensory level to T12, the epidural infusion comprising of 0.125% Bupivacaine with 2mics/ml Fentanyl will be started at 4ml/hr in both the groups.
If the patients complain of pain, the existing infusion rate will be given as bolus as rescue analgesic & the infusion rate will be stepped up by 1ml increments. The maximum allowed infusion rate is 7ml/hr. If the patient still complains of pain Inj Morphine will be administered intravenously in 3mg increments and the total volume of local anesthetic given epidurally for 24hrs in the post operative period will be noted in both the groups.
 
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