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CTRI Number  CTRI/2021/10/037190 [Registered on: 08/10/2021] Trial Registered Prospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the pain after lower back spine surgery by using different modes of anaesthesia 
Scientific Title of Study   Comparison of Spinal anaesthesia with intrathecal morphine as additive Vs. General anaesthesia with erector spinae plane block for lumbar spine surgery; A prospective, randomised study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Soundarya S V 
Designation  Postgraduate student, Department of Anaesthesia  
Affiliation  SDM Medical college and research hospital, 
Address  Department of Anaesthesiology SDMCMSH, Manjushree Nagar, Sattur. Dharwad– 09.
Department of Anaesthesiology SDMCMSH, Manjushree Nagar, Sattur. Dharwad– 09.
Dharwad
KARNATAKA
570009
India 
Phone  8892866815  
Fax    
Email  soundaryasv1203@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sameer Desai 
Designation  Professor,Department of Anaesthesiology. 
Affiliation  SDM Medical college and research hospital, 
Address  Department of Anesthesiology,SDMCMSH, Manjushree Nagar, Sattur. Dharwad – 09
Department of Anaesthesiology SDMCMSH, Manjushree Nagar, Sattur. Dharwad– 09.
Dharwad
KARNATAKA
570009
India 
Phone  9480752566  
Fax    
Email  Sameer.desai@sdmmedicalcollege.org  
 
Details of Contact Person
Public Query
 
Name  Dr Sameer Desai 
Designation  Professor,Department of Anaesthesiology. 
Affiliation  SDM Medical college and research hospital, 
Address  Department of Anesthesiology,SDMCMSH, Manjushree Nagar, Sattur. Dharwad – 09
Department of Anaesthesiology SDMCMSH, Manjushree Nagar, Sattur. Dharwad– 09.
Dharwad
KARNATAKA
570009
India 
Phone  9480752566  
Fax    
Email  Sameer.desai@sdmmedicalcollege.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Medical Science and Hospital (SDMCMSH), Manjushree Nagar, Sattur. Dharwad– 09. 
 
Primary Sponsor  
Name  SDMCMSH Manjushree Nagar Sattur Dharwad  
Address  Department of anaesthesia. SDMCMSH, Manjushree Nagar, Sattur. Dharwad – 09 
Type of Sponsor  Private medical college 
 
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 Soundarya S V  SDM College of Medical Sciences and Hospital, Dhrawad.  Department of anaesthesia. Sri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital (SDMCMSH), Manjushree Nagar, Sattur. Dharwad – 09.
Dharwad
KARNATAKA 
8892866815

soundaryasv1203@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMCMS&H/IEC:7:2021  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General anaesthesia with erector spinae plane block for lumber spine surgery.  GROUP 2-General anaesthesia with ESPB provided by injecting 20 ml of 0.25% of Bupivacaine on each side, total 40 ml of drug.  
Intervention  Spinal anaesthesia with intrathecal morphine for lumber spine suregery.  GROUP 1-Spinal anaesthesia with 200mcg of intrathecal morphine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I-III patients undergoing either single-
or double-level laminectomy or disc surgery

will be admitted into the study. 
 
ExclusionCriteria 
Details  Patients will be excluded if they had: a history of severe cardiac disease, hepatic or renal disease, bleeding abnormalities, severe spinal stenosis.
Allergy or any contraindication for Diclofenac or infectious processes that would contraindicate neuraxial anaesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of analgesia by assessing NRS score(0-10).  10min,30min,1hour,2houre,4hour,8hour,12hour,24hour and 48hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of procedure,intraoperative blood loss,surgeon statisfaction grading(%),patient statisfaction score(%).  Time of incision,20min,30min,40min,50min,60min,75min,90min,105min
120min,end of surgery. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   25/10/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   References-1. Jellish WS, Thalji Z, Stevenson K, Shea J. A prospective randomized study comparing short- and intermediate-term perioperative outcome variables after spinal or general anesthesia for lumbar disk and laminectomy surgery. Anesth Analg. 1996 Sep; 83:559-64. 2. Sadrolsadat SH, Mahdavi AR, Moharari RS, Khajavi MR, Khashayar P, Najafi A, Amirjamshidi A. A prospective randomized trial comparing the technique of spinal and general anesthesia for lumbar disk surgery: a study of 100 cases. Surg Neurol. 2009 Jan; 7:60-65. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Lumbar laminectomy and discectomy are commonly performed surgery, which is associated with significant postoperative pain and patient discomfort.  General anaesthesia and spinal anaesthesia have both shown to be suitable techniques for patients undergoing lumbar spine surgery. GA may be preferred because of greater patient acceptance and the ability to perform operations of long duration in the prone position with a secured airway. Anaesthesiologists who favour regional techniques, however, believe regional anaesthesia reduces blood loss and improves operating conditions by decreasing peripheral venous pressure which reduces venous blood loss in the operative field. In addition, since these operations are usually performed in the prone position, the awake patient can self-position to avoid nerve injury to the brachial plexus and pressure necrosis to the face that may occur in the mispositioned patient under GA. In two uncontrolled large retrospective trials, spinal anaesthesia (SA) was considered to be at least as good or better than typical expectations for GA in patients undergoing lumbar spine surgery. 

The studies  using spinal anaesthesia with intrathecal morphine as an additive have shown to provide analgesia lasting up to 24 hours after the surgery.

There are few studies describing erector spinae plane block (ESPB), along with GA to provide good postoperative analgesia for lumbar spine surgeries. ESPB has been shown to provide analgesia up to 6-8 hours and decrease the postoperative analgesic requirement.

Based on the literature survey little is known or less explored with respect to comparing EPSB with GA to intrathecal morphine as an additive to SA. 

In this study patients will be randomly allocated in two groups by computer generated randomisation. Patients in SA group will receive Spinal anesthesia in sitting position  using 0.5% heavy Bupivacaine (15 mg) and Morphine 200 microgram intrathecally. For patients in GA group, anaesthesia induction will be by intravenous Fentanyl 2 mcg/kg, Propofol 2mg/kg and Vecuronium 0.1mg/kg, and anaesthesia will be maintained by Isoflurane and 50% nitrous and 50% oxygen. Intraoperatively if the patient has features suggestive of inadequate analgesia (as indicated by tachycardia, hypertension, increased SPI> 60), rescue analgesics like fentanyl 1mcg/kg aliquots will be given. After general anaesthesia in prone position ultra sound guided EPSB will be will be performed at T12 level, using 20 ml of 0.25% of Bupivacaine on each side, total 40 ml of drug. At surgical completion the anaesthetics will be discontinued, and patients will be extubated and monitored in the PACU. They will be shifted to ward and they will be followed up for every 6th hour up to 24 hours after surgery to assess the postoperative pain and their analgesic requirement  by using NRS score and their side effects.If patient complains of pain then there will be rescue analgesia Whenever the patients have NRS score more than 3 then they will receive 75 mg Diclofenac intravenously. The intravenous Diclofenac can be repeated if patients NRS score more than 3 after 8 hours. If the pain doesn’t subside then intravenous paracetamol 1 gm will be given. They will be shifted to ward and they will be followed up for every 6th hour up to 24 hours after surgery to assess the postoperative pain and their analgesic requirement and their side effects


 
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