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CTRI Number  CTRI/2019/11/022185 [Registered on: 27/11/2019] Trial Registered Prospectively
Last Modified On: 14/12/2020
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 study the effectiveness of magnesium sulphate in the management of pain after a multilevel posterior spinal surgery , when the drug is injected into the veins by means of an electronic device which functions on patient demand. 
Scientific Title of Study   Comparing the efficacy of magnesium sulphate as an adjuvant to fentanyl and ketamine in patient controlled analgesia for post operative pain management ,in patients undergoing multilevel posterior spinal fusion-A double blinded randomised controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shalaka Ashok Tembhurne 
Designation  PG Resident 
Affiliation  Christian Medical College ,Vellore 
Address  Department of Anaesthesia,CMC Vellore
Department of Anaesthesia,CMC Vellore
Vellore
TAMIL NADU
632004
India 
Phone  04162282680  
Fax    
Email  shalaka.abc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrSajan Philip George  
Designation  professor  
Affiliation  Christian Medical College ,Vellore 
Address  Department of Anaesthesia,CMC Vellore

Vellore
TAMIL NADU
632004
India 
Phone  04162282680  
Fax    
Email  sajanpg@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Shalaka Ashok Tembhurne 
Designation  PG Resident 
Affiliation  Christian Medical College ,Vellore 
Address  Department of Anaesthesia ,CMC Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9423668845  
Fax    
Email  shalaka.abc@gmail.com  
 
Source of Monetary or Material Support  
FLUID resaerch fund ,CMC vellore 
 
Primary Sponsor  
Name  christian medical college vellore 
Address  Christian Medical College and Hospital,Vellore,632004 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Shalaka Ashok Tembhurne  christian medical college vellore  Department of anaesthesia,Christian medical college and hospital ,vellore
Vellore
TAMIL NADU 
9423668845

shalaka.abc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board ,CMC ,Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  fentanyl and ketamine  PCA solution containing 20mcg/ml of fentanyl,0.01mg/kg/ml of ketamine. 
Intervention  magnesium sulphate   PCA solution containing 20mcg/ml of fentanyl,0.01mg/kg/ml,20mg/ml of magnesium sulphate 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.patients undergoing multilevel posterior spinal fusion
2.ASA I and II
3.Age between 18-65 years
4.GFR (glomerular filtration rate ) >90ml/min/1.73m2
 
 
ExclusionCriteria 
Details  1. ASA III and IV
2. GFR <90ml/min/1.73m2
3. Patients diagnosed with hypermagnesemia
4. Chronic opioid use
5. Allergy to study drugs
6. Inability to use PCA pumps.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative pain score at rest and on movement.   post operative pain score at rest and on movement at 0,6,12,24,36 and 48 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
number of boluses administered at end of 24 hours,assessment of quality of sleep,post operative nausea and vomiting,sedation scores,chronic pain assessment.  0,6,12,24,36,48 hours and 3 months 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 1 
Date of First Enrollment (India)   01/12/2019 
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="0"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Management of post operative pain is challenging. Posterior spine fusion surgeries require high quality analgesia to maximize functional recovery . Adequate post-operative analgesia helps with early mobilisation, brief hospital stay, reduced hospital costs and increased patient comfort. Magnesium sulphate through NMDA receptor blockade in the central nervous system and calcium channel blockade has been reported to be an effective anesthetic adjunct for pain relief and also in blunting somatic , autonomic and endocrine reflexes induced by noxious stimuli. Magnesium sulphate has been used in the form of bolus and /or continuous intravenous infusions intra-operatively and has been found to attenuate acute post-operative pain in total knee arthroplasty. In this randomized control trial , we aim to assess the efficacy of magnesium sulphate as an additive in intravenous patient controlled analgesia (PCA) for post operative pain management ,in patients undergoing multilevel posterior spinal surgeries between the age of 18-65 years. The participants are randomized into two study groups - group 1 receiving PCA fentanyl and ketamine and group 2 receiving PCA fentanyl ,ketamine and magnesium .Postoperatively the pain scores will be assessed at specified time intervals as specified in the attached sheet. Vitals , sedation score ,nausea ,vomiting and quality of sleep will be monitored regularly in the ward. Number of boluses delivered to each participant will be noted 24 hours after surgery .Serum magnesium levels will be checked pre operatively and at 24 ,48 hours after starting the PCA infusion . Magnesium toxicity will be monitored by regular assessment of knee jerk, urine output and respiratory rate. Participants will be followed up at 3 months of surgery for the assessment of chronic pain relief.

 
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