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CTRI Number  CTRI/2024/02/063085 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 22/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Erector spinal plane block]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate bilateral versus unilateral erector spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy 
Scientific Title of Study   To evaluate bilateral versus unilateral erector spine plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy 
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 Kirti Kshetrapal  
Designation  Professor  
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  9215650615  
Fax    
Email  Kamalkirti47@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kirti Kshetrapal  
Designation  Professor  
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak


HARYANA
124001
India 
Phone  9215650615  
Fax    
Email  Kamalkirti47@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Urmi Malik  
Designation  Postgraduate student  
Affiliation  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8607642799  
Fax    
Email  Urmi.malik1997@gmail.com  
 
Source of Monetary or Material Support  
Pt B D Sharma, PGIMS Rohtak  
 
Primary Sponsor  
Name  Pt B D Sharma PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PGIMS Rohtak  
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 
Dr Urmi Malik  Pt.B D Sharma PGIMS, Rohtak   Department of Anaesthesiology and Critical Care, 2nd floor Modular OT Complex
Rohtak
HARYANA 
8607642799

Urmi.malik1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bilateral erector spinae plane block  Under all aseptic precautions, the probe will be placed longitudinally 3cm lateral to the T8 level.Following identification of the transverse process and erector spinae muscle, the needle will be inserted with in-plane approach from cranial to caudal direction.Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualing the lifting of erector spinae muscle away from the transverse process. Twenty millimetres of 0.25%bupivacaine will then be administered bilaterally in group B patients. 
Intervention  Unilateral Erector spinae plane block  Under all aseptic precautions, the probe will be placed longitudinally 3cm lateral to the T8 level.Following identification of the transverse process and erector spinae muscle , the needle will be inserted with in-plane approach from cranial to caudal direction.Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualising the lifting of erector spinae muscle away from the transverse process.twenty millimetres of 0.25%bupivacaine will the be administered on the right side in group U patients. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients of either gender, aged 18-60 years belonging to American society of Anaesthesiologists (ASA) I-II scheduled for elective laparoscopic cholecystectomy under general anaesthesia will be included in the study. 
 
ExclusionCriteria 
Details  Patients with :
Contraindications to regional anaesthesia such as coagulopathy, infection at the site of puncture etc.
Known history of hypersensitivity/anaphylaxis/contraindications to bupivacaine or its components
Pregnancy
Mental disorders/o
Illness
BMI >35kg/m2
Chronic drug/analgesic abuse
Refusal to give consent
Severe renal or liver diseases
Will be excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post operative numerical rating scale (NRS) for pain following bilateral versus right sided ESPB in patients undergoing laparoscopic cholecystectomy.  Score at rest and score on coughing at
15 min
1 hr
6 hr
24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia  Duration of postoperative analgesia (in hours) 
Total analgesic consumption in 24hrs  Total analgesic consumption in 24hrs 
Postoperative nausea and vomiting  Postoperative nausea and vomiting 
Block related complications, if any  Block related complications, if any 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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 3/ Phase 4 
Date of First Enrollment (India)   11/03/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Closed to Recruitment of Participants 
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  
The laparoscopic technique for cholecystectomy surgery has gained popularity in recent years and it is the most commonly performed surgical procedure for benign biliary diseases. Being minimally invasive, it offers advantage of shorter hospital stay, faster recovery, lesser pain and reduced perioperative complications as compared with open techniques performed for biliary diseases.Laparocopic cholecystectomy (LC) produces significant moderate to severe immediate postoperative pain despite being a minimally invasive technique. Furthermore, postoperative pain can affect physical and mental health of the patient and may lead to secondary complications such as nausea, vomiting, slowed bowel movements, muscle spasms, thrombosis, cardiopulmonary complications and delayed recovery of organ function. Perioperative pain management goals are to alleviate suffering, discomfort, early mobilization, rapid recovery, rapid discharge and most importantly patient satisfaction.4 Due to multiple pain sources, multimodal analgesia approaches with non steroidal inflammatory agents, opioids, dexamethasone, gabapentin, local anesthetics infiltration to port sites and regional anesthetic techniques such as epidural, transversus abdominis plane block, erector spinae plane block, oblique subcostal transversus abdominis plane block and paravertebral blocks have been used for pain management in perioperative period following LC.Ultrasound-guided interfascial plane blocks are being commonly used for management of postoperative pain and one of the such novel technique is the USG guided erector spinae plane block (ESPB). USG guided erector spinae plane block has emerged as a well established block for providing perioperative and postoperative analgesia in LC patients.ESPB has shown its value and efficacy in acute as well as in chronic pain management. All blocks will be performed in the sitting position. All the blocks will be performed 20min prior to surgery in sitting position at T8 level in the preoperative room. Under all aseptic precautions, the probe will be placed longitudinally 3 cm lateral to the T8 level. Following identification of the transverse process and erector spinae muscle, the needle will be inserted with in-plane approach from cranial to caudal direction. Confirmation of correct needle tip placement will be done by injecting 5ml saline and visualizing the lifting of the erector spinae muscle away from the transverse process. Twenty milliliter of 0.25% bupivacaine will be then administered on the right side in group U patients and bilaterally at the T8 level in group B patients. The spread of the injectate beneath the erector spinae muscle will be visualized in both the cranial and caudal directions. ESPB will be given bilaterally in patients of group B and unilaterally(right side) in patients of group U. Time at which the block is given will be noted (To).
 
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