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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients undergoing lumbosacralspine surgeries , |
|
Intervention / Comparator Agent
|
|
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. |