FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/01/049255 [Registered on: 27/01/2023] Trial Registered Prospectively
Last Modified On: 25/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A randomised controlled study to assess the effectiveness of ultrasound guided bilateral erector spinae block (a type of inter-fascial plane block) for post-operative pain relief in laparoscopic (keyhole) abdominal surgeries. 
Scientific Title of Study   A randomised controlled study to assess the efficacy of ultrasound guided bilateral erector spinae block for post-operative analgesia in laparoscopic abdominal surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shariaa Ghufran 
Designation  Junior Resident  
Affiliation  Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.

Aligarh
UTTAR PRADESH
202002
India 
Phone  8272869687  
Fax    
Email  shariaa.amu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Qazi Ehsan Ali 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.

Aligarh
UTTAR PRADESH
202002
India 
Phone  7417701769  
Fax    
Email  qaziehsanali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shariaa Ghufran 
Designation  Junior Resident  
Affiliation  Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh. 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh.

Aligarh
UTTAR PRADESH
202002
India 
Phone  08272869687  
Fax    
Email  shariaa.amu@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh. 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh. 
Address  Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh. 
Type of Sponsor  Government 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 
Shariaa Ghufran  Jawaharlal Nehru Medicine College and Hospital, AMU, Aligarh.  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, AMU, Aligarh.
Aligarh
UTTAR PRADESH 
8272869687

shariaa.amu@gmail.com 
 
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: 3||Administration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector spinae plane block  Bilateral Ultrasound guided Erector Spinae Plane Block will be given in the patients undergoing laparoscopic abdominal surgeries under General anaesthesia. It will be given after the completion of the surgery and before the extubation of the patient. 15 ml of 0.25% Bupivacaine would be used in each side 
Comparator Agent  No erector spinae plane block (Control Group)  In control group, only conventional intravenous analgesics will be administered and no fascial plane block will be given. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients undergoing elective laparoscopic abdominal surgery under general anaesthesia in JN Medical College and Hospital in time periods between 2022-24.
ASA grade I and II.
BMI between 18 to 25kg/sq.m 
 
ExclusionCriteria 
Details  Patient’s refusal.
History of allergy to analgesics.
Allergic to local anaesthetic
Skin infection at puncture site.
Deranged coagulation profile.
Pulmonary, renal, cardiac or any other systemic disorder.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Duration of post-operative analgesia.  It will be assessed as time from the time of extubation to the time when patient request for the first dose of analgesic. 
 
Secondary Outcome  
Outcome  TimePoints 
Total analgesic required in 24hr period  Rescue analgesic when patient complains of pain with NRS score more than 3 (with minimum interval of 6 hours between two doses). Total doses of analgesic required by patient in 24 hours post-operatively will be calculated in morphine milligram equivalent dosage. 
NRS score for assessing post operative pain  First recording will be recorded in recovery room when patient will be well oriented to time place and person. It will be taken as 0 hour. Then it will be taken at 2nd hour, 6th hour and 24th hour. Further, mean of the four values will be taken. 
Complications- allergic reactions, nausea/vomiting, unsuccessful block, accidental intra-vascular injection & it’s consequences and pneumothorax.  Postoperatively, in first 24 hours. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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/ Phase 3 
Date of First Enrollment (India)   01/02/2023 
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="2"
Months="0"
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)?  

Response - NO
Brief Summary  

A randomised controlled study to assess the efficacy of ultrasound guided bilateral erector spinae block for post-operative analgesia in laparoscopic abdominal surgeries: 

During abdominal surgery pain is multifactorial.

Insufficient post-operative pain management hampers the achievement of good recovery after surgery and the risk of postoperative complications like delayed mobilization, ileus, nausea, chronic pain, with which patient’s satisfaction can seriously be affected with prolonged hospital stay that increases the financial burden both at the individual and societal level.

Thus, adequate post-operative pain management in patients undergoing abdominal surgery is though challenging but rewarding task.

Some of the efficacious analgesic options are intravenous drugs mainly the opioids, epidural block, fascial plane blocks like Transversus abdominis plane (TAP) block and Erector spine plane (ESP) block

Opioids are successful in the treatment of visceral pain but not so effective for somatic pain and are related to side effects such as constipation, nausea and vomiting, pruritus, and life threatening respiratory depression. 

Frequent concerns with epidural block are hypo-coagulability and post-operative hypotension.

One of the recent techniques include facial plane blocks like Erector spine plane (ESP) and Transversus Abdominis Plane (TAP) block.

With ESP block, both visceral as well as somatic analgesia are provided, acute as well as chronic pain are relieved by it and can be utilised for analgesia at cervical, thoracic & m abdominal levels with minimal side effects. ESPB has shown significant analgesic effect with lesser pain scores and lower opioid consumption during various abdominal surgeries in the post-operative period. 

In our study we will compare the efficacy of Ultrasound guided bilateral erector spine block in post-operative analgesia in abdominal surgeries with another group in which block won’t be given.

 
Close