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CTRI Number  CTRI/2024/02/062847 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to comparatively evaluate the analgesic efficacy of ultrasound guided erector spinae plane block versus wound site infiltration in patients undergoing open nephrectomy. 
Scientific Title of Study   Ultrasound guided erector spinae plane block versus wound site infiltration for postoperative analgesia in patients undergoing open nephrectomy 
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 Udeyana Singh 
Designation  Associate Professor Anaesthesia 
Affiliation  Dayanand Medical College and Hospital 
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB
141001
India 
Phone  8968580004  
Fax    
Email  udeyana@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Inayat Jearth 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital  
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB
141001
India 
Phone  9815855260  
Fax    
Email  inayat.jearth80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Inayat Jearth 
Designation  PG Resident Anaesthesia 
Affiliation  Dayanand Medical College and Hospital  
Address  Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB
141001
India 
Phone  9815855260  
Fax    
Email  inayat.jearth80@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Medical college and hospital,Tagore Nagar,Civil lines,Ludhiana.141001 Punjab India 
 
Primary Sponsor  
Name  Dayanand Medical college and Hospital 
Address  Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab 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 Udeyana Singh  Dayanand Medical College and Hospital ludhiana  Department of Anaesthesia , first floor
Ludhiana
PUNJAB 
8968580004

udeyana@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Ethical committee,Dayanand medical college and hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N19||Unspecified kidney failure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ultrasound guided erector apinae plane block  Patients in group A will recieve 30ml of 0.2% ropivacaine after induction of general anaesthesia. 
Comparator Agent  Wound site infiltration  Patients in group B will receive subcutaneous infiltration of 30ml of 0.2% ropivacaine along the line of incision at the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients of 18-75 years of age, American Society of Anaesthesiologists (ASA) I-III undergoing open nephrectomy with flank incision  
 
ExclusionCriteria 
Details  1. Patients allergic to local anaesthetics being used
2. Infection at the site of infiltration of local anaesthetic
3. Patients with uncontrolled bleeding diathesis evidenced by history and laboratory investigations
4. Patients with Psychiatric disorder
5. Patients unable to comprehend VAS score
6. Patients with chronic opioid abuse
7. Refusal to participate in the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the analgesic efficacy of ESPB and wound site infiltration in open nephrectomy patients in post operative period.  Comparative consumption of the total amount of rescue opioid analgesic in a 24 hour period among both the groups will be noted and bidirectional Visual Analogue Scale(VAS) will be recorded at rest and on movement preoperatively i.e prior to block administration before induction of general anesthesia and then postoperatively every hourly for the first 4 hours, 2 hourly for next 2 hours and 4 hourly till 24 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
Duration of analgesia and Quality of revovery questionnare  Quality of recovery questionnare at 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 2 
Date of First Enrollment (India)   29/02/2024 
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="6"
Days="29" 
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  

Acute pain management in open nephrectomy is a challenging issue, due to large subcostal flank incision that is generally employed to have a wide operative field but, it requires considerable amount of muscle cutting giving rise to somatic pain transmitted through intercostal nerves at T9-T11. In addition, visceral pain is also a component of postoperative pain which is transmitted through sympathetic fibers T8-T12 spinal segments. There are limited studies on erector spinae plane block being used for pain relief in patients undergoing open nephrectomy, hence we propose to study the analgesic efficacy of erector spinae plane block vs wound site infiltration in open nephrectomy surgeries. A randomized observational study will be conducted in ASA I-III patients, aged 18-75 years, of either sex, undergoing open nephrectomy with flank incision under general anesthesia with endotracheal intubation.These patients will be randomly allocated into 2 groups, one group will receive ultrasound guided erector spinae plane block with 30 ml of 0.2% ropivacaine after the induction of general anesthesia and second group will receive  local infiltration of 30 ml of 0.2% ropivacaine (LIA) along the line of skin incision at the end of surgery. Duration of pain relief and  Visual Analogue scale (VAS) scores for pain will be recorded as primary outcome measures, with quality of recovery score (QoR-15) and cumulative amount of rescue analgesia needed, as secondary outcome variables.

 
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