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CTRI Number  CTRI/2020/09/027996 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 17/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Post operative image guided pain relief with local anaesthesia in patients undergoing open nephrectomy  
Scientific Title of Study   Ultrasound guided Erector Spinae Plane Block for post operative analgesia in patients undergoing open nephrectomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Deepak Oberoi 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Dehradun Uttaranchal

Dehradun
UTTARANCHAL
248140
India 
Phone  9876251926  
Fax    
Email  drdeepakoberoi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Soumya Bindra 
Designation  Postgraduate Resident 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Dehradun Uttaranchal

Dehradun
UTTARANCHAL
248140
India 
Phone  9205208488  
Fax    
Email  soumya.bindra@gmail.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Dr Deepak Oberoi 
Designation  Associate Professor 
Affiliation  Himalayan Institute of Medical Sciences 
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University

Dehradun
UTTARANCHAL
248140
India 
Phone  9876251926  
Fax    
Email  drdeepakoberoi@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Himalayan Institute of Medical Sciences  
 
Primary Sponsor  
Name  Himalayan Institute of Medical Sciences 
Address  Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Dehradun Uttaranchal  
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 Rohan Bhatia  Himlayan Institute of Medical Sciences   Department of Anaesthesia Himalayan Institute of Medical Sciences Swami Rama Himalayan University Jolly Grant Dehradun Uttaranchal
Dehradun
UTTARANCHAL 
9971014232

rohanbhatia@srhu.edu.in 
 
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: N288||Other specified disorders of kidney and ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Only general anaesthesia and PCA morphine in PACU   Patients will receive only general anaesthesia during surgery. After being transferred to PACU patients will receive intravenous morphine by Patient Controlled Analgesia pump 
Intervention  Ultrasound guided Erector Spinae Plane Block with general anaesthesia and PCA morphine in PACU   Patients will be given general anaesthesia and after surgery, before reversal of anaesthesia, ultrasound guided Erector Spinae Plane Block will be given using linear transducer at T9 level with 0.5% Ropivacaine, 30 ml. After reversal of anaesthesia patients will be tranferred to PACU and intravenous morphine will be given by Patient Controlled Analgesia pump. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA physical status I and II
2. Age between 18 to 60 years.
3. Scheduled for open nephrectomy surgery.  
 
ExclusionCriteria 
Details  1. Patient refusal for procedure.
2. Allergic to local anaesthetics.
3. Infection at local site.
4. Bleeding disorders.
5. Severe kidney dysfunction.
6. BMI above 30kg/m2.
7. Inabilty to give informed consent.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy  To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy 
 
Secondary Outcome  
Outcome  TimePoints 
To study the pain intensity using Numeric Rating Scle   Pain intensity using a 10 point Numeric Rating Scale at 30 minutes, 2,4,6,8,12,18,24 hours respectively.  
To study the time of first analgesic used over 24 hours   Time for first requested analgesic from time in PACU till discharge.  
To study any opioid related side effects   Any side effects from opiods within the first 24 hours.  
To study patient satisfaction using a Likert- scale questionnaire   Patient satisfaction about the overall pain management and quality of sleep at night on post operative day 0 using a Likert-scale with 0-6 score points  
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   28/09/2020 
Date of Study Completion (India) 01/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/10/2021 
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)?  

Response - NO
Brief Summary   Post operative pain is a major concern after any surgery. Inadequate control of post operative pain is associated with a delay in recovery leading to an increase in incidence of chronic pain. An adequate post operative analgesia allows for early ambulation thereby reducing risks associated with long hospital stay and ultimately leading to enhanced recovery after surgery. While numerous methods exist for post operative pain management, a single modality of approach remains ineffective. 
Patients undergoing renal surgeries often have impaired renal functions and require judicious use of systemic analgesics. In the post operative period, patients undergoing nephrectomy are often managed with either opioids or epidural analgesia. In such scenarios, multimodal analgesia is a better choice since it is associated with reduced opioid requirement and its adverse effects. 
The ultrasound guided Erector Spinae Plane Block is a newer regional anaesthesia technique being currently explored as a viable option for analgesia. it is performed by injecting local anaesthetic in the plane between the rector spinae muscle and transverse process. The transverse process is easily identifiable and at a relative distance from any major vascular or neural structures. The local anaesthetic diffuses into paravertebral spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of thoracic spinal nerves thus providing extensive analgesia with a single puncture. 
Keeping in mind a multimodal approach to postoperative pain and the ease of adminstration of the Erector Spinae Plane Block, this study is being planned with the view that ultrasound guided erector spinae plane black and intravenous patient contolled analgesia have an additive effect on postoperative pain management and would enable enhanced recovery after surgery and decrease post operative analgesic consumption in patients undergoing open nephrectomy. 
 
SAMPLE SIZE 

The sample size was determined by using the NRS to compare the effectiveness by assuming a difference of 1 in NRS between the two groups (group1 and group 2 ) as clinically significant, thus sample size of 24 patients per group were considered necessary to detect statistical significance with an effect size of 1.0 at alpha 0.05 and power of 90%

 The formula for calculated sample size is given below

n = (σ12 + σ2 ) . (Z α + Zβ) 2

 (M1 - M2) 2

 

 

 = (12 + 12).(1.96+1.64)2

  (1) 2

 

 = (1+1)*12.96

1

  = 24

 

where Zα/2 is the critical value of the Normal distribution at α/2 (e.g. for a confidence level of 95%, α is 0.05 and the critical value is 1.96), Zβ is the critical value of the Normal distribution at β (e.g. for a power of 90%, β is 0.1 and its critical value is 1.282) and σ 1 and σ 2 are the Standard deviations of the two groups and M1 and M2 are the means of two groups.


 
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