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
|
|
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
|
|
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. |