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CTRI Number  CTRI/2021/07/034629 [Registered on: 06/07/2021] Trial Registered Prospectively
Last Modified On: 07/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARISON OF ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK (PAIN RELIEF TECHNIQUE) PERFORMED WITH DIFFERENT CONCENTRATIONS OF MEDICINE (BUPIVACAINE) FOR POST SURGERY PAIN SEVERITY, SURGICAL STRESS AND SATISFACTION IN PATIENTS UNDERGOING GALL BLADDER REMOVAL (LAPAROSCOPIC CHOLECYSTECTOMY) SURGERY. 
Scientific Title of Study   COMPARISON OF THE EFFICACY OF ULTRASOUND–GUIDED ERECTOR SPINAE PLANE BLOCK PERFORMED WITH DIFFERENT CONCENTRATIONS OF BUPIVACAINE FOR POSTOPERATIVE ANALGESIA, REDUCTION IN PERIOPERATIVE STRESS MARKERS AND PATIENT SATISFACTION IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS : A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, CONTROLLED CLINICAL TRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ALI SALODA 
Designation  FIRST YEAR PG RESIDENT ANAESTHESIA 
Affiliation  HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
South
DELHI
110062
India 
Phone  9928297948  
Fax    
Email  ali.saloda@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kharat Mohd Batt 
Designation  Professor and Head Of Department, Department of Anaesthesia 
Affiliation  HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
South
DELHI
110062
India 
Phone  9622457554  
Fax    
Email  hod.anaesthesia@himsr.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr ALI SALODA 
Designation  FIRST YEAR PG RESIDENT ANAESTHESIA 
Affiliation  HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH 
Address  OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
South
DELHI
110062
India 
Phone  9928297948  
Fax    
Email  ali.saloda@gmail.com  
 
Source of Monetary or Material Support  
Hamdard Institute of Medical Sciences and Research, Delhi 
 
Primary Sponsor  
Name  Dr Ali Saloda 
Address  Hamdard Institute of Medical Sciences and HAHC Hospital, Hamdard Nagar, New Delhi, 110062 
Type of Sponsor  Other [Self] 
 
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 Ali Saloda  HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH, HAMDARD NAGAR, DELHI 110062  OPERATION THEATRE, 8th FLOOR, ANAESTHESIA DEPARTMENT, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH HAMDARD NAGAR DELHI 110062
South
DELHI 
9928297948

ali.saloda@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH AND ASSOCIATED HAH CENTENARY HOSPITAL(IEC-HIMSR)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1 Control Group   Control Group - No block 
Intervention  Group 2 - USG - ESPB with 0.25% bupivacaine  USG Guided Erector spinae plane block given at the level of T7, with 20 ml of 0.25% bupivacaine bilaterally. 
Intervention  Group 3 - USG - ESPB with 0.375% bupivacaine  USG Guided Erector spinae block given at the level of T7, with 20ml of 0.375% bupivacaine bilaterally.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All patients aged 18-65yrs, posted for elective laparoscopic cholecystectomy, with American society of Anaesthesiologist (ASA) physical status I-II shall be included in the study. 
 
ExclusionCriteria 
Details  1. Patient refusal.
2. Patients with known allergy to local anaesthetics.
3. Patients with presence of bleeding disorders.
4. Patients with infection at injection sites.
5. Patients with prior addiction or analgesics abuse (opioid and nonsteroidal anti-inflammatory drug medications).
6. Patients with BMI <18.5kg/m2 and >34.9kg/m2.
7. Patients with weight under 50kgs.
8. Patients with liver or renal insufficiency.
9. Patients with history of psychiatric or neurological disease, deafness.
10. Patients in whom the total surgical duration exceeds 2 hours (after incision) or surgery is converted to open cholecystectomy.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the reduction in Numerical Rating Scale (NRS) score at 30 minutes after extubation between the control group, group receiving ESPB with bupivacaine 0.25% and the group receiving ESPB with bupivacaine 0.375% respectively.  30 minutes after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare total intraoperative fentanyl requirement in the 3 groups.
2. To compare total analgesic consumption postoperatively in 24 hours between the 3 groups.
3. To compare change in pre and post-operative surgical stress markers (NLR- neutrophil-lymphocyte ratio, PLR- platelet-lymphocyte ratio, Serum albumin, Blood glucose) between the 3 groups.
4. To compare patient satisfaction scores between the three groups.
 
24 hours after extubation.
For stress markers- 6 hours and 24 hours after extubation 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/07/2021 
Date of Study Completion (India) 31/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
The laparoscopic technique is the standard of care for cholecystectomy surgery. Although considered a minimally invasive procedure, it results in moderate to severe immediate postoperative pain. Postoperative pain consists of both somatic and visceral pain components. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain.
Due to multiple sources of pain multimodal analgesia approaches have been used. Narcotic medications like opioids help in reducing somatic and visceral pain but they are associated with increased postoperative nausea and vomiting, ileus, sedation, and delayed hospital discharge.
Blocks like Transverse abdominis plane block and oblique subcostal TAP block only help in reducing the somatic pain and have no effect on the visceral component of pain. As the erector spinae fascia extends from the nuchal fascia cranially to the sacrum caudally, the local anaesthetic drugs extend through several levels, and the block can be effective over a large area.
Better postoperative analgesia, reduced nausea, vomiting and reduced surgical stress is expected to enhance the recovery of patients after surgery and lead to greater patient satisfaction. So our study intends to find out the effectiveness of USG-ESPB using different concentrations of bupivacaine on postoperative pain management, reducing perioperative surgical stress and improving patient satisfaction in patients undergoing laparoscopic cholecystectomy.
The procedure shall be performed after inducing general anaesthesia to the patient for surgery. Following intubation, the patient shall be placed in a lateral position and USG guided block shall be given bilaterally at the level of T7 spinous process.
The following parameters shall be recorded in the first 24 hours: NRS score at the surgical site at rest, on movement and on deep breathing at various time intervals, shoulder pain, intraoperative fentanyl requirements, total postoperative analgesic consumption, the incidence of nausea and vomiting and complications related to ESP block. A patient satisfaction survey shall be done on all patients.

 
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