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CTRI Number  CTRI/2017/11/010581 [Registered on: 21/11/2017] Trial Registered Retrospectively
Last Modified On: 01/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Randomised control Trial 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the pain relief in spine surgery from two pain killer drugs (Bupivacaine and Morphine) delivered regionally around spinal cord using ultrasound guidance. 
Scientific Title of Study   "To compare the efficacy of ultrasound guided caudal local anaesthetics alone and with morphine for perioperative analgesia in spine surgery"  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Kumar Malviya 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi, India. 
Address  Room No 5011, Teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
475, Hardev puri Gautam Nagar, Near Father Agnel School, New Delhi
South
DELHI
110049
India 
Phone  09981319419  
Fax    
Email  amit2411@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chhavi Sawhney 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi, India. 
Address  Room No 5011, Teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
Room No 5011, Teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
South
DELHI
110029
India 
Phone  9868397816  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Amit Kumar Malviya 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences, New Delhi, India. 
Address  Room No 5011, Teaching Block, Department of Anesthesiology, Pain Medicine and Critical care, AIIMS, New Delhi
475, Hardev puri Gautam Nagar, Near Father Agnel School, New Delhi
South
DELHI
110049
India 
Phone  09981319419  
Fax    
Email  amit2411@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar,New Delhi, 110029, India 
 
Primary Sponsor  
Name  AIIMS  
Address  All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India PIN-110029 
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 Amit Kumar Malviya  All India Institute of Medical Sciences, Ansari Nagar, New Delhi  Department of Anaesthesia, Pain Medicine and Critical Care, Room No-5011 5th Floor AIIMS Teaching Block
South
DELHI 
09981319419

amit2411@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committe for post graduate research , AIIMS, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients undergoing lumbosacralspine surgeries ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. All patients, aged between 18-60 years, undergoing lumbosacral spine surgery ( trauma and degenerative) will be included in the study.
2. Patients willing to give consent .
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Patients with head injury or raised intracranial pressure.
3. Patents with coagulopathy.
4. Patients with infection at the local site.
5. Patients with allergy to the local anaesthetic drug.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Time to first activation of PCA
2.Total Morphine consumption
3. VAS
 
VAS – Immediate postoperative period, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Total intraoperative fentanyl requirement
2. Incidence of Adverse effects.
i.e. Respiratory depression
Pruritus
Nausea & vomiting
 
0(basal),5mins,10mins,15 mins, at SKIN INCISION,5 min ,10 min,15min,20 min,25 min,30 min, At INSTRUMENTATION,30 mins,60mins,90 mins

 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/04/2016 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary    After obtaining institutional ethics committee approval, 40 patients scheduled for lumbosacral spine surgery will be included in the study.

 

Preanaesthetic checkup:  

A detailed preoperative evaluation will be done including details and duration of disease, traumatic or degenerative cause , treatment taken, duration of treatment, and dose of preoperative analgesics for pain relief.

Routine investigations, Coagulation profile , ECG and Chest x ray will be performed.

Patients will be briefed about the PCA (Patient Controlled Analgesia) device to be used postoperatively and patient dexterity with the device will be ensured.

Visual analog scale will also be explained.

 Patients will receive standard premedication with T.Alprazolam 0.5mg at night prior to day of surgery and two hours before surgery.


Anaesthesia technique:
 

After mid night fasting, patient, in operating room peripheral venous access will be placed. Standard intraoperative monitoring with ECG,  SpO2,  NIBP,  EtCO2 will be instituted.

After preoxygenation, anaesthesia will be induced with Inj. Propofol  2-3mg/kg i.v , Inj. Fentanyl  2µg/kg i.v. , and Inj. Atracurium followed by endotracheal intubation. Anaesthesia will be maintained with Oxygen : N2O (50 : 50) and Isoflurane ( MAC 0.8  -1).

I.V. fluids will be administered as per the requirement. Intra operative monitoring will include ECG, EtCO2, anesthetic gases, SpO2 , NIBP, and blood loss.

 

Following prone positioning, the patients will be randomly divided into two groups using computer generated randomisation.

One group will receive ultrasound guided caudal epidural block with  morphine 50 µg/kg diluted with 20 ml of 0.25% bupivacaine. Second group will receive ultrasound guided caudal epidural block with 0.25% bupivacaine alone. The block will be administered using 18 gauge tuohy needle.

 

Tranexamic acid (bolus 10 mg/kg followed by 1mg/kg/hour infusion) will be given to reduce perioperative blood loss.

 Rescue boluses of fentanyl 0.5-1 µg/kg, will be given if there is an increase in the heart rate or blood pressure more than 20% of the baseline after ensuring adequate depth of anaesthesia and normovolemia.

 

Thirty minutes prior to extubation, injection Ondansetron (4mg) will be given to prevent postoperative nausea and vomiting . After the completion of surgery neuromuscular block will be reversed with Inj. neostigmine 40-70mcg/kg and Inj.glycopyrrolate 7-10mcg/kg. Trachea will be extubated when patient fulfills the clinical criteria(regular breathing, respiratory rate>10 and <30 and tidal volume> 5-6 ml/kg).

 

Postoperative Management and assessment

Postoperatively patients will be shifted from Operation room to Recovery room (PACU).  PCA device will be attached and patient instructed to take boluses on demand as soon as cognitive function recovers. Each bolus will deliver 1mg morphine, with a lockout period of 10 minutes. No basal infusion will be provided. Paracetamol 1g intravenous infusion (20mg/kg for smaller patients) 8 hourly will be continued for 24 hours. 

 
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