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CTRI Number  CTRI/2019/02/017467 [Registered on: 05/02/2019] Trial Registered Prospectively
Last Modified On: 24/01/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare injection of drugs (ketamine, levobupivacaine or a combination of both ketamine and levobupivacaine) given under the skin before the surgery for removing uterus in providing pain relief after surgery 
Scientific Title of Study   COMPARISON OF KETAMINE, LEVOBUPIVACAINE AND A COMBINATION OF BOTH AS PRE-INCISION SURGICAL SITE INFILTRATION FOR POSTOPERATIVE ANALGESIA AFTER ABDOMINAL HYSTERECTOMY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANUJ YADAV 
Designation  Postgraduate student 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, Ansari Nagar, New Delhi-110029 South

South
DELHI
110029
India 
Phone  9896907686  
Fax    
Email  anujyadav004@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Parul Mullick 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital,Ansari Nagar, New Delhi South DELHI 110029

South
DELHI
110029
India 
Phone  9810606262  
Fax    
Email  parash93@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Parul Mullick 
Designation  Professor 
Affiliation  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital,Ansari Nagar, New Delhi South DELHI 110029

South
DELHI
110029
India 
Phone  9810606262  
Fax    
Email  parash93@yahoo.com  
 
Source of Monetary or Material Support  
No funding, monetary or material support will be required. Study will be conducted in Government hospital,VMMC and Safdarjung hospital. The hospital provides free treatment to patients. 
 
Primary Sponsor  
Name  Vardhman Mahavir Medical College and Safdarjung Hospital 
Address  Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital,Ansari Nagar, New Delhi- 110029 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil  not applicable 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anuj Yadav  Vardhman Mahavir Medical College and Safdarjung Hospital  Maternity Operation Theatre Department of Anaesthesia and Intensive Care, VMMC and Safdarjung Hospital, Ansari Nagar
South
DELHI 
9896907686

anujyadav004@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,VMMC &Safdarjung Hospital, New Delhi-110029  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ketamine plus levobupivacaine combination   Patients will receive ketamine 1 mg/kg in levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. 
Comparator Agent  ketamine, levobupivacaine   Patients will receive ketamine 1 mg/kg in saline, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. Patients will receive levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Patients fulfilling the American society of Anaesthesiologists (ASA) physical status I or II criteria,age from 18years to 75years,Duration of surgery less than 2 hours
 
 
ExclusionCriteria 
Details  Patients with allergy to study drugs,cardiovascular disease (such as hypertension, tachycardia, arrhythmia, congestive heart failure, and coronary artery disease,Psychiatric disorder,Neurological disease, increased intracranial pressure, seizure disorder, glaucoma, hyperthyroidism
5. Liver or renal dysfunction.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
cumulative pethidine requirement in 24 h   24 h after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first pethidine requirement  0 to 24h 
cumulative pethidine requirement in 1, 2, 6, and 12 h time frame  1, 2, 6, and 12 h after surgery 
Pain scores at rest and on movement postoperatively at 0, 15 and 30 min and at 1, 2, 6, 12, and 24 h  0, 15 and 30 min and at 1, 2, 6, 12, and 24 h after surgery 
Occurrence of side effects such as nausea, vomiting, sedation and hallucinations  0 to 24h 
Patient satisfaction regarding postoperative analgesia at 24 h  24h after surgery 
 
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   N/A 
Date of First Enrollment (India)   01/03/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Using a computer-generated random number table, patients will be allocated randomly into one of the three study groups:

Group K:  Patients will receive ketamine 1 mg/kg in saline, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group L:  Patients will receive levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group KL: Patients will receive ketamine 1 mg/kg in levobupivacaine 0.25%, total volume 20 ml as subcutaneous infiltration, in and around the incision line as a rectangle, 5 min before skin incision.

Group assignments will be concealed within opaque envelopes.

PROCEDURE

In the operating room, monitors (electrocardiogram, noninvasive blood pressure, pulse oximeter) will be applied and baseline readings noted. Anaesthesia will be induced with midazolam (1mg), fentanyl (2 µg/kg), propofol 10% (2 mg/kg) followed by vecuronium bromide (0.1 mg/kg) for facilitating insertion of Pro Seal laryngeal mask airway (PLMA).  Anaesthesia will be maintained on oxygen and nitrous oxide (33:66) in isoflurane. Fentanyl (1µg/kg) bolus dose will be given at completion of one hour of anaesthesia induction, for meeting intraoperative analgesic requirement.

Under strict aseptic precautions, after cleaning and draping the patient, the study drug will be infiltrated subcutaneously, in and around the incision line as a rectangle by the operating surgeon. The surgical incision will be given after 5 min have elapsed from the time of study drug administration. Approximately 30 min before the end of surgical procedure, 1 g paracetamol will be given intravenously over 15 min and 4mg ondansetron will be given intravenously over 5 min. At the end of surgery, volatile anaesthetics will be discontinued, residual neuromuscular block will be antagonized with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg and the PLMA will be removed when the patient is fully conscious.

Postoperatively, all patients will receive 1 g paracetamol intravenously 8 hourly for pain relief. If VAS score is ≥ 4, pethidine 0.4 mg/kg will be given intravenously, if the VAS score did not decrease within 10 more min, pethidine 0.2 mg/kg will be given to the patient with maximum dose of 1 mg/kg in any 4 h. The total pethidine consumption and time to the first additional pethidine need will be recorded. Finally, occurrence of adverse effects such as nausea, vomiting, sedation and hallucinations will be noted and treated accordingly.

Following parameters will be noted on arrival of patient in the PACU at 0, 15 and 30 min, and at 1, 2, 6, 12, and 24 h postoperatively:

Haemodynamic parameters and respiratory rate (RR)

Severity of pain at rest and on movement using Visual Analogue Scale score (VAS) where 0 indicates no pain, and 10 is worst pain possible. 

Time to first pethidine requirement and cumulative pethidine requirement in 1, 2, 6, 12 and 24 h time frame.

Occurrence of side effects such as nausea, vomiting, sedation, hallucinations.

Occurrence and severity of nausea will be noted. Nausea severity will be graded as none/mild /moderate/severe. Retching will be considered as vomiting for statistical purpose.

Level of sedation will be assessed using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation). 

Patient satisfaction from postoperative analgesia will be assessed at 24 h postoperatively using a 5-point scale (1 = very unsatisfied, 2 = unsatisfied, 3 = fair, 4 = satisfied, and 5 = very satisfied).    


 
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