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CTRI Number  CTRI/2023/03/051022 [Registered on: 23/03/2023] Trial Registered Prospectively
Last Modified On: 21/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to assess the analgesic effect of two different methods in patients undergoing laparoscopic removal of gallbladder surgeries. 
Scientific Title of Study   A prospective Randomised double blind controlled study comparing the analgesic efficacy of Intraperitoneal instillation of Ropivacaine with Dexmeditomidine and USG guided erector spinae plane block in patients undergoing elective laparoscopic cholecystectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dilip Kumar S N 
Designation  Junior Resident  
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, 1st floor,New surgical block,KR hospital,Mysore Medical College and Research Institute, Irwin Road, Mysuru Mysore KARNATAKA 570001

Mysore
KARNATAKA
570001
India 
Phone  8553208085  
Fax    
Email  diliphemanth143@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shashikala TK 
Designation  Professor 
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, 1st floor,New surgical block,KR hospital,Mysore Medical College and Research Institute, Irwin Road, Mysuru Mysore KARNATAKA 570001

Mysore
KARNATAKA
570001
India 
Phone  9148650639  
Fax    
Email  drshi72@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shashikala TK 
Designation  Professor 
Affiliation  Mysore Medical College and Research Institute 
Address  Department of Anesthesiology, 1st floor,New surgical block,KR hospital,Mysore Medical College and Research Institute, Irwin Road, Mysuru Mysore KARNATAKA 570001

Mysore
KARNATAKA
570001
India 
Phone  9148650639  
Fax    
Email  drshi72@gmail.com  
 
Source of Monetary or Material Support  
KR Hospital, Irwin Road, Devaraja Mohalla, Yadavagiri, Mysore, Karnataka - 570001 
 
Primary Sponsor  
Name  Department of Anaesthesiology  
Address  Mysore Medical College and Research Institute, Mysuru, Karnataka - 570001 
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 
Dilip Kumar SN  KR Hospital  Department of Anaesthesiology, 1st floor,New surgical block,Irwin Road, Devaraja Mohalla, Yadavagiri, Mysuru KARNATAKA
Mysore
KARNATAKA 
8553208085

diliphemanth143@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mysore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group ESP  0.375% 30ml of Ropivacaine plus 50mcg Dexmeditomidine in 2ml NS.Time taken to perform the intervention is 10mins.After that ,patient will be monitored for 24hours. 
Comparator Agent  Group IP  Intraperitoneal instillation of 30ml 0.375% Ropivacaine plus 50mcg Dexmedetomidine in 2ml NS.Time taken to perform the intervention is 5mins.After the intervention, the patient will be monitored for 24hours. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All ASA grade I and grade II patients between 20-60 years age group 
 
ExclusionCriteria 
Details  · All ASA grade III and IV patients.
· Diabetes and Hypertension.
· Cardiovascular, respiratory and neurological disorders.
· Obesity (BMI>30kg/m2)
. Drug allergy 
 
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 
Time for first request of analgesia postoperatively is noted which gives the duration of analgesia
Postoperative visual Analogue score scale at various time intervals


 
Immediately after surgery,1st hour,2nd hour,4th hour,6th hour,8th hour,12th hour,16th hour,20th hour,24th hour 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse effects such as nausea,vomiting,sedation,respiratory depression, shoulder pain,shivering assessed postoperatively at various time intervals  Immediately after surgery,1st hour,2nd hour,4th hour,6th hour,8th hour,12th hour,16th hour,20th hour,24th hour 
 
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 3 
Date of First Enrollment (India)   04/04/2023 
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="0"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The study population will be divided into 2 groups of 30 subjects each.
1. Group IP will receive intraperitoneal instillation of 30ml 0.375% Ropivacaine plus 50 mcg
of Dexmeditomidine in 2ml NS
2. Group ESP will receive USG Guided ESP Block of 15ml 0.375% Ropivacaine plus 25mcg
of Dexmedetomidine in 1ml NS on each side(total of 30ml of 0.375% Ropivacaine plus 50 mcg of Dexmeditomidine in 2ml NS)
After obtaining informed written consent, on the previous day of surgery, a thorough pre anaesthetic evaluation (PAE) will be done and pre medicated with Tab. Ranitidine 150mg + Tab. Alprazolam 0.5mg. Pre-operatively and at the time of pre-anaesthetic evaluation, all the patients will be explained about the study protocol and how to score VAS to indicate their pain
perception by identifying 0 as no pain and 10 was worst imaginable pain. Patients will be asked to be Nil Per Oral for 6 hours.
On the day of surgery, patients will be shifted to Operating Room and multi parameter monitor will be connected (EDAN iM80). Baseline readings of SBP, DBP, MAP, HR will be noted. IV access will be taken using 18G IV cannula and crystalloid fluids (NS or RL) will be on flow. In Group ESP, the patient will be in the lying down lateral position with the support of assistants. The preliminary scan will be done to define and mark the required level(T7).The spinous processes will be identified and marked as midline, bilaterally 3cm from midline has to be marked for entry point. The parts will be painted with iodine and drapped .The scan will be started from lateral to medial after adjusting usg machine. The anatomical landmarks will be identified by usg machine and T7 transverse process and other 3 layers of muscle from posterior to anterior(trapezius, rhomboid, erector spinae) will be identified. After identifying sonoanatomy at T7 level, 10cm 23G needle will be inserted under USG guidance by In plane technique ,aiming the needle towards the T7 transverse process. After touching the transverse process, a total of 15ml Ropivacaine 0.375% +25mcg Dexmeditomidine(1ml),total 16ml will be administered on each side. The local anesthetic with Dexmeditomidine will be given in increments with careful repetitive aspiration to avoid intravascular injection.. Following ESP block, general anesthesia will be induced with Inj Xylocard 1.5mg/kg + 2mg /kg Inj Propofol I.V + Inj Vecuronium 0.1mg/kg body weight, after premedication with 1mg Midazolam + 2mcg/kg Fentanyl + Dexamethasone 8mg + Inj. Glycopyrollate 0.01mg/kg and preoxygenation for 3 mins.
Patients will be mask ventilated for 3 minutes and intubated with appropriate endotracheal tube. After confirming the tube inside trachea, patient will be connected to ventilator and maintained with 66% nitrous oxide and 33% oxygen with 1% isoflurane. Intra-operatively intra-abdominal pressure of 12 to 14 mm Hg will be maintained. Minute ventilation will be adjusted to maintain normocapnia (ETCO2 34 to 38mmHg).. Based on the existing literature, lower umbilical part will not be covered by the block. So will be requesting the surgeon to infiltrate the area with 5ml of 0.5% Ropivacaine.After extubation,
The patient pain will be monitored using visual analogue score scale(VAS) at times 0 to 30mins,The 0 point of time will be the moment the patient recovered from general anesthesia and responding to verbal commands. In the post-operative ward, if VAS score >4, patients will be prescribed Inj.Paracetamol 1gm IV every 6th hourly. If the pain has not subsided with Paracetamol, Inj.Tramadol 100mg IV will be given as per patient’s requirement. Total analgesic consumption in 24hrs will also be assessed(IV Paracetamol, INJ Tramadol).Patient will be monitored for any adverse effect like nausea, vomiting, sedation, respiratory depression, hypotension and bradycardia.
But, in Group IP ,patients will be pre-medicated with Inj.Midazolam 1mg IV, Inj.Glycopyrolate 0.2mg IV, Inj.Fentanyl 2mcg/kg IV, Inj.Dexamethasone 8mg IV. Patient will be pre-oxygenated for 3 minutes with 100% oxygen. Patients will be induced with Inj.Xylocard 1.5mg/kg + Inj.Propofol 2mg/kg + Inj.Vecuronium 0.1mg/kg IV. Patients will be mask ventilated for 3 minutes and intubated with appropriate endotracheal tube. After confirming the tube inside trachea, patient will be connected to ventilator and maintained with 66% nitrous oxide and 33% oxygen with 1% isoflurane. Intra-operatively intra-abdominal pressure of 12 to 14 mm Hg will be maintained. Minute ventilation will be adjusted to maintain normocapnia (ETCO2 34 to 38mmHg). Just after insertion of trocar, the study drug, which is 30 ml 0.375% Ropivacaine with 50mcg Dexmeditomidine in 2ml NS will be instilled through it.After extubation,the patient pain will be monitored using visual analogue score scale(VAS) at times 0 to 30mins,The 0 point of time will be the moment the patient recovered from general anesthesia and responding to verbal commands. In the post-operative ward, if VAS score >4, patients will be prescribed Inj.Paracetamol 1gm IV every 6th hourly. If the pain has not subsided with Paracetamol, Inj.Tramadol 100mg IV will be given as per patient’s requirement.
Time to first request of analgesia, total dose consumption of analgesics like Inj.Paracetamol and Inj.Tramadol in 24 hours will be recorded in both the groups. The incidence of shoulder pain, adverse effects like hypotension, bradycardia, nausea, vomiting, sedation will be recorded.
 
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