| CTRI Number |
CTRI/2024/08/072673 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare efficiency of Ultrasound guided block using a mixture of 0.2 percentage Ropivacaine (local anesthetic) with Tramadol(pain killer) vs 0.2 percentage Ropivacaine with Dexamethasone (steroid)vs intravenous pain killers for managing pain after spine surgeries |
|
Scientific Title of Study
|
Effectiveness of Ultrasound guided Erector Spinae Plane Block(ESPB) using 0.2 percentage Ropivacaine with Tramadol vs 0.2 percentage Ropivacaine with Dexamethasone vs Conventional intravenous analgesics for post operative pain management in lumbar spine surgeries: A Randomized double blinded study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Midhun Madhavan |
| Designation |
Post graduate Resident |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Department of Anaesthesiology
IMS and SUM Hospital
SOA University
Bhubaneswar
Odisha
Khordha
ORISSA
751003
India |
| Phone |
7978472297 |
| Fax |
|
| Email |
midhunmadhavan12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushree Das |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Department of Anaesthesiology
First floor
IMS and SUM Hospital
SOA University
Bhubaneswar
Odisha
Khordha
ORISSA
751003
India |
| Phone |
9132425105 |
| Fax |
|
| Email |
das.sushri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Midhun Madhavan |
| Designation |
Post graduate Resident |
| Affiliation |
Institute of Medical Sciences and SUM Hospital |
| Address |
Department of Anaesthesiology
IMS and SUM Hospital
Bhubaneswar
Odisha
Khordha
ORISSA
751003
India |
| Phone |
7978472297 |
| Fax |
|
| Email |
midhunmadhavan12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Institute Of Medical Sciences and SUM Hospital, Bhubaneswar, Odisha, PIN - 751003 |
|
|
Primary Sponsor
|
| Name |
Dr Midhun Madhavan |
| Address |
Post graduate student
Department of Anaesthesiology
Institute of Medical Sciences and SUM Hospital
Bhubaneswar
Odisha, pin- 751003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Midhun Madhavan |
Institute of Medical Sciences and SUM Hospital |
Department of Anaesthesiology
Institute of Medical Sciences and SUM Hospital
SOA University
Bhubaneswar
Khordha
ORISSA |
7978472297
midhunmadhavan12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane Block |
Erector Spinae Plane Block using 0.2% Ropivacaine (30 ml) with Tramadol 50mg(1ml) given in the interfascial plane using ultrasound guidance. |
| Intervention |
Erector Spinae Plane Block |
Erector Spinae Plane Block using 0.2% Ropivacaine(30ml)with Dexamethasone 8mg(2ml) given in the interfascial plane using ultrasound guidance. |
| Comparator Agent |
IV analgesia |
Using conventional IV analgesics
1)Inj. Fentanyl IVrepeated every 40 minutes according to the body weight.
2) Inj. Paracetamol 1g IV infusion |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA1 and ASA2 patients
Undergoing upto two level lumbar spine surgeries
Surgery duration within 3 hours |
|
| ExclusionCriteria |
| Details |
ASA3 and ASA4
coagulation disorders
Severe cardiopulmonary,hepatic or renal diseases
Not willing to participate
Patient known for opioid dependency
Skin infection at local sites
Known allergy to anesthetic drugs
Surgery duration more than 3 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Compare the intensity of pain using the Visual Analogue Scale (VAS)scores at different time points postoperatively between the groups
2.Compare the time at which first rescue rescue analgesia was required in three groups |
Immediate post extubation, 1st,2nd,4th,8th,12th and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
N/A |
|
|
Target Sample Size
|
Total Sample Size="99"
Sample Size from India="99"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomized double blinded comparative study will be conducted at our institution over a period of 6 months. In this study 90 ASA I and ASA II patients between age 18- 65 years with BMI < 35kg/m2 posted for lumbar spine surgeries included.
A preanaesthetic check-up will be done which included history, general physical examination and checking the vital parameters of the patients such as blood pressure, pulse, respiratory rate and systemic examination, and ASA grading.The patients with major neurological, cardiovascular, metabolic, respiratory, renal disease or coagulation abnormalities will be excluded.
All patients will be given tablet Alprazolam 0.25 mg on the night before surgery for anxiolysis. Bilateral ESPB technique will be fully explained. Written informed consent will be taken from all the patients. In the operating room, all the standard anaesthesia monitors will be attached and induction of general anaesthesia will done using standard anaesthesia technique. All patients will be given inj. Glycopyrrolate, Inj. Midazolam, Inj. Fentanyl, Inj. Loxicard(2%) and induce with Inj. Propofol 2mg/kg followed by Inj. Cisatracurium 0.1 mg/kg to facilitate endotracheal intubation.Anaesthesia will be maintained with oxygen and nitrous oxide (50:50), isoflurane upto 1% v/v and intermittent dose of Inj Cisatracurium 0.05 mg/kg for muscle relaxation. Inj fentanyl will be repeated every 40min to patients in group C. Mechanical ventilation will be adjusted to normocapnia (EtCO2 values of 35–38 mm of Hg). All the patients will be given IV Paracetamol 1gm intraoperatively.
Continuous monitoring of Heart Rate (HR), Blood Pressure (BP), Oxygen Saturation (SpO2) and Electrocardiography (ECG) will be done intraoperatively. At the end of surgery, tracheal extubation will be performed after reversal of neuromuscular blockade with Inj neostigmine 0.05 mg/kg and Inj glycopyrrolate 0.01 mg/kg. The postoperative pain assessment will be performed using VAS score. The VAS score will be recorded at zero hour (being immediate post extubation), 1, 2, 4, 6, 12 and 24 hours. Any complication related to method or drugs will be noted. Injection Dynapar 75mg AQ intravenous (i.v.) will be given as rescue analgesic when patient complains of pain and VAS score was ≥5. Time to first rescue analgesia will also noted. Until first rescue analgesia, no other analgesics will be administered. The patient as well as the anaesthetist assessing pain in the postoperative period will unaware of group allocation.
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