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CTRI Number  CTRI/2019/12/022513 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 08/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two variety modes of pain decreasing methods on well being in patients undergoing backbone operation. 
Scientific Title of Study   Epidural morphine and ketamine versus intravenous morphine and ketamine on postoperative quality of recovery(QoR) in patients undergoing transforaminal lumbar interbody fusion:A single blinded randomised controlled trial.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSailaja Karri 
Designation  Pg registrar in anaesthesiology 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Department of anesthesiology Christian medical college Vellore Employment Number:21771

Vellore
TAMIL NADU
632004
India 
Phone  8074276504  
Fax    
Email  sailaja.sailuu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ramamani mariappan 
Designation  Professor 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Department of neuroanaesthesia Christian medical college Vellore Employment Number : 50916

Vellore
TAMIL NADU
632004
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  DrRamamani mariappan 
Designation  Professor 
Affiliation  CHRISTIAN MEDICAL COLLEGE 
Address  Department of neuroanaesthesia Christian medical college Vellore Employment Number : 50916

Vellore
TAMIL NADU
632004
India 
Phone  9443753184  
Fax    
Email  ramamani@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Silver,Research and Ethics Committee Institutional Review Board Fluid Research Grant -Major research grant Office of Research, I Floor, Carman Block Christian Medical College vellore Tamil Nadu 632002. Tel :0416-2284294 Email: research@cmcvellore.ac.in 
 
Primary Sponsor  
Name  Institutional Review Board  
Address  Institutional review Board Christian medical college Research Section office Vellore India 
Type of Sponsor  Private 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 
Sailaja Kari  Christian Medical college  Main Operation Theatre Department of Anesthesia Christian Medical College Vellore -632004 Tamil Nadu.
Vellore
TAMIL NADU 
8074276504

sailaja.sailuu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics committee Silver, Office of Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  RCT  Epidural Inj .Morphine 8 mg, Ketamine 60 mg will be diluted upto 50 ml in a CADD pump and will be delivered at 1 ml/hr for 48 hours. 
Comparator Agent  RCT  PCA through CADD pump Morphine and Ketamine at the concentration ration of 1:1 .Patients will get 0.015ml /kg /bolus with the lock out period of 10 mins ( max upto 6 bolus dose /hour ) will be delivered for the IV group. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.ASA grade I and II
2.Patients undergoing Transforaminal Lumbar Interbody fusion.
3.Normal renal function. 
 
ExclusionCriteria 
Details  1.ASA III and IV
2.BMI >30
3. Impaired renal function.
4.Intraoperative csf leak
5.Previous surgical procedures in lumbo sacral region
6.Patients with psychiatric illness.
7.Obstructive sleep apnoea. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Quality of recovery score between the two groups of patients using QoR 15 Score.   Primary investigator will assess the Quality of recovery at the end of 48 hours after operation in the ward. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the analgesic efficacy of the two techniques using Numeric rating scale at movement.
2.Patient satisfaction score (0-10).
3.Time of ambulation
4.Length of hospital stay
5. Sedation score, respiratory rate,Ponv,pruritus
6.Time of receiving first rescue analgesia for breakthrough pain. 
1. In the post anesthesia care unit by recovery staff at intervals of half an hour till discharge from recovery room
.

2 Post operative ward -.Pain nurse and ward staff will asess at the arrival to post operative ward, at 2 hrs, 6 hrs,12 hrs,24 hrs,36 hrs,48 hrs.

3. Primary investigator will assess at end of 24 hrs and 48 hours after suggery.
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/12/2019 
Date of Study Completion (India) 10/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 10/11/2021 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Planning to publish after completion of study. Potential Authors in future 1. Dr.Sailaja Karri 2.Dr. Ramamani Mariappan 3.Dr.Krishna prabhu 4.Dr. Edmond Jonathan G 5.Dr.Karen ruby Lionel 6.Dr.Jayashhelan L 7.Dr.Ari G Chacko 8.Dr. Prasad Kanna 9.Dr. Mammen philip 10. Sr. Jermaiah Samuel. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Pain is an important factor affecting postoperative quality of recovery (QoR) after open transforaminal lumbar interbody fusion (TLIF) surgery. It not only delays discharge from hospital but also affects the patient’s physical and psychological recovery. Continuous administration of intravenous morphine with or without ketamine is routinely used to treat postoperative pain after major spine surgery at our institution. Continuous administration
of I.V morphine at fixed rate can lead to either overdose or under dose. So we have decided to administer i.v morphine through patient control analgesia system, where patient can control their pain by themselves by administering morphine and ketamine using a pump.
Epidural morphine has been shown to decrease postoperative pain and opioid consumption after spine surgery and when coupled with the simultaneous administration of Ketamine, a further decrease in the total opioid dose and side effects may be expected. In this study we wish to compare two routes of administration of these drugs for providing postoperative analgesia in patients undergoing open TLIF. Our hypothesis is that the epidural administration of morphine and ketamine would be superior to intravenous administration of these drugs. Forty ASA 1 and 2 patients will be randomized into two groups after obtaining informed consent. Patients with age > 70 years, ASA 3 and 4, BMI > 30, Obstructive sleep apnoea, impaired renal function (serum creatinine > 1.4mg/dl), moderate to severe chronic obstructive lung disease, H/o previous surgical procedures in the lumbosacral region, H/o psychiatric illness all will be excluded. Group A will receive epidural morphine and ketamine (Inj. Morphine 8 mg, ketamine 60 mg diluted with normal saline, total volume made to 50 ml ,injected through the epidural catheter at 1 ml/hour, while patients in Group B will receive the same drugs intravenously at the concentration ratio of 1:1 via the CADD pump. Group B patients will get 0.015 ml/kg/bolus with the lockout period of 10 mins (max up to 6 bolus dose/hr) for 48 hours. The intraoperative anaesthetic techniques in the two groups will be standardised. Patients will be assessed at specified times after surgery with regard to verbal rating scale (VRS) for pain and for the side effects like postoperative nausea and vomiting, sedation, respiratory depression, hallucination. Patient satisfaction score and quality of recovery score will be assessed at the end of 48 hours
 
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