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
|
|
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
|
|
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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