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CTRI Number  CTRI/2021/05/033316 [Registered on: 03/05/2021] Trial Registered Prospectively
Last Modified On: 29/04/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Postoperative pain management after lower abdominal suegeries 
Scientific Title of Study   COMPARISON OF THE EFFECTS OF INTRAVENOUS LIGNOCAINE AND KETAMINE ON POSTOPERATIVE PAIN AFTER LOWER ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  OT Complex First floor Department of Anaesthesia Dr S N medical collage Jodhpur
OT Complex First floor Department of AnaesthesiaDr S N medical collage Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Singariya 
Designation  Senior Professor 
Affiliation  Dr. S.N. medical collage, Jodhpur 
Address  OT Complex First floor Department of AnaesthesiaDr S N medical collage Jodhpur
OT Complex First floor Department of AnaesthesiaDr S N medical collage Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  09414803554  
Fax    
Email  geetamanojkamal@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Sharma 
Designation  Anaesthesia Resident 
Affiliation  Dr S N medical collage, Jodhpur 
Address  OT Complex First floor Department of AnaesthesiaDr S N medical collage, Jodhpur
OT Complex First floor Department of AnaesthesiaDr. S.N. medical collage, Jodhpur
Jodhpur
RAJASTHAN
342001
India 
Phone  08595118533  
Fax    
Email  jyoti.js741@gmail.com  
 
Source of Monetary or Material Support  
Dr S N Medical College Jodhpur 
 
Primary Sponsor  
Name  Dr S N Medical College Jodhpur 
Address  Shastri nagar Jodhpur 
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 
DrGeeta Singariya  MDM hospital, Dr. S.N. medical collage, Jodhpur  OT Complex First floor Department of Anaesthesia M D M Hospital Dr S N Medical College Shastri Nagar Dr S N medical collage, Jodhpur
Jodhpur
RAJASTHAN 
9414803554

geetamanojkamal@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: K639||Disease of intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group C (Control group)  Group C will receive an equal volume of 0.9% normal saline. 
Intervention  Group K (Ketamine group)  Group K will receive iv ketamine bolus of 0.15mg/kg at the induction of anesthesia followed by infusion of 0.15 mg/kg/hr intraoperatively.  
Intervention  Group L (Lignocaine group)   Group L will receive iv lignocaine bolus of 1.5mg/kg at the induction of the anesthesia followed by infusion of 1.5mg/kg/hr intraoperatively . 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA I and II with lower abdominal surgery under general anesthesia, surgical time up to 2 hours. 
 
ExclusionCriteria 
Details  Patients planned for postoperative mechanical ventilation or regional anesthesia/analgesia, perioperative gabapentin, magnesium, or nitrous oxide use, pregnancy or breastfeeding, morbid obesity (BMI ≥ 35 kg/m2 ), allergy to study medications, contraindication to lidocaine (severe cardiac arrhythmia) or ketamine (psychiatric disorder, substance abuse, uncontrolled hypertension, pulmonary hypertension, increased intracranial or intraocular pressure, use of MAO inhibitors), chronic preoperative opioid use (≥ 90 morphine mg equivalents per day for > 3 months), significant preoperative hepatic dysfunction (ALT or AST > 5 times normal or planned liver transplantation), preoperative cardiac failure (left ventricular ejection fraction ≤ 40%), unable to communicate study instructions. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare total mean opioid consumption(fentanyl) in first 24 hours postoperatively in three groups receving lignocaine, ketamine and normal saline.  first 24 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1.VAS scores
2.Time to request first analgesic after surgery
3.Hemodynamic parameters
4.Post-operative hospital length of stay (days).
5.Adverse effects
 
24 hours 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   N/A 
Date of First Enrollment (India)   04/05/2021 
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="9"
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   The present study will be conducted in the department of anesthesiology and critical care of DR. S.N. MEDICAL COLLEGE AND ATTACHED GROUP OF HOSPITALS , JODHPUR after obtaining institutional ethics committee approval and written informed consent from study subjects.  

Patients posted for the lower abdominal surgery will be undergoing a thorough preoperative evaluation which included proper history, general condition of the patient, examination of CVS, RS, CNS, vertebral columns, and airway assessment. The basic and the relevant investigations (Hemoglobin, packed cell volume, platelet count, bleeding time, clotting time, renal function test, liver function test, electrocardiogram (ECG), chest X-ray PA view) will be done preoperatively. Patients who fulfilled the inclusion criteria will be included in the study. The day before surgery all participants will be instructed about the visual analog scale (VAS).

After taking the patient in operation theatre, patient will be monitored using pulse oximetry (SPo2), non-invasive BP (NIBP) and continous ECG. A peripheral intravenous (IV) line will be secured with 18 G cannula on the forearm and 0.5ml/kg/hr crystalloid solution will be started. According to the group allocation, loading dose will be given of iv lignocaine or iv ketamine or normal saline 0.9%, followed by infusion at a fixed rate till the end of the surgery.

The patient will be induced with injection fentanyl 2 mcg/kg, injection propofol 2mg/kg and injection succinylcholine 2 mg/kg, intubated, controlled ventilation started with inhalational Isoflurane according to MAC and muscle relaxant injection atracurium 0.5mg/kg will be given. The patient’s ECG, NIBP, and SPo2 will be continuously monitored intraoperatively. Supplemental analgesia will be provided with fentanyl (1 μg/kg) IV bolus, if HR or mean blood pressure (MBP) exceeded 30% of the preoperative values even after the adequate depth of anaesthesia. Continuous monitoring of HR, NIBP, and SpO2 will be done every 15 min till the end of surgery. The number of doses and total dose of fentanyl used as supplement analgesia intraoperatively will be noted.  All the patients will be given 1gm of iv paracetamol and 4mg of iv ondansetron 15 minutes before reversal. After completion of the surgery neuromuscular blockade will be reversed with injection neostigmine and injection glycopyrrolate. After a demonstration of recovery from the muscle relaxant, patients will be extubated and shifted to the recovery room. The total duration of the anaesthesia and surgery will be noted. If any side effect or hemodynamic instability occurs before inducing or after induction of patient then infusion will be stopped immediately and the patient will be managed accordingly and that patient will be excluded from the study.

The VAS, and  Ramsay sedation score will be noted in the first 24 hrs postoperative period. The time duration of a patient staying in the recovery room will be noted. Patient’s haemodynamic parameters and patient pain perception measured by visual analogs scale,  ramsays sedation score monitored at 1hr , 2hr , 3hr , 4hr , 6hr , 8hr , 10hr , 12hr , 18hr & 24hr. Inj fentanyl 1 mcg/kg will be given as rescue analgesia if VAS ≥ 4 or on patients demand. The time of the first rescue analgesic (fentanyl) and total dose of fentanyl used in the first 24 hr postoperative period will be noted. Any adverse effect like tinnitus, numbness, psychomotor disturbances, haemodynamic instability, cardiac arrhythmias  will be noted. Patient’s satisfaction score (4 = excellent,  3 = good,  2 = fair,  1 = poor) will be noted after 24 hours of surgery. Total duration of hospital stay will be noted 


 
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