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
|
|
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
|
|
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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