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CTRI Number  CTRI/2025/04/085365 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two interventions for pain control in post operative period in patients undergoing lumbar spine surgery 
Scientific Title of Study   Comparison of intrathecal morphine versus erector spinae plane block for postoperative pain control in patients for lumbar spine surgery:a double-blind prospective comparative 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  Arfan Ahmed J S 
Designation  Assistant professor  
Affiliation  Velammal medical college hospital and research institute  
Address  Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai
Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai
Madurai
TAMIL NADU
625009
India 
Phone  7795194452  
Fax    
Email  arfanahmed007@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manikandan B 
Designation  Head of department of anaesthesia 
Affiliation  Velammal medical college hospital and research institute  
Address  Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai.
Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai.
Madurai
TAMIL NADU
625009
India 
Phone  9443753737  
Fax    
Email  drmanib@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arfan ahmed J S 
Designation  Assistant professor  
Affiliation  Velammal medical college hospital and research institute  
Address  Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai
Department of anaesthesia, Velammal medical college hospital and research institute, Chinthamani, Madurai
Madurai
TAMIL NADU
625009
India 
Phone  7795194452  
Fax    
Email  arfanahmed007@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Velammal medical college hospital and research institute  
Address  Velammal medical college and hospital Velammal Village, Madurai - Tuticorin, Airport-Mattuthavani Ring Rd, Chinthamani, Madurai, Tamil Nadu Pin 625009 
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 Arfan ahmed J S  Velammal medical college hospital and research institute,Madurai  GSOT Fifth floor, Velammal medical college hospital and research institute, Velammal Village, Madurai-Tuticorin Ring Road, Anuppanadi, Madurai. 625009
Madurai
TAMIL NADU 
7795194452

arfanahmed007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,Velammal Medical College Hospital and Research Institute,Madurai.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector spinae plane block  40ml of 0.25% of bupivacaine is given under ultrasound guidance before surgery. 
Intervention  Intrathecal Morphine  0.2 mg of morphine is given intrathecaly before surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA 1 & 2 patients scheduled to undergo elective lumbar spine surgery 
 
ExclusionCriteria 
Details  1.Patient refusal.
2.Allergy to any of the study drugs.
3.Contraindications to regional technique e.g.,infection around site of block ,any coagulation disorder, sepsis.
4.History of analgesic dependence (long term use) and opiate tolerance.
5.Contraindications to intrathecal morphine e.g.,local infection in intrathecal administration site.
6.More than two level of vertebrae involving in surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
1.VAS Score.
2.Postoperative analgesia use paracetamol/tramadol usage. 
1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours. after operation.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time to first analgesic requirement after surgery.
2.Incidence of intervention related side effects in both the groups(Post-operative nausea/vomiting, respiratory depression, pruritus, urinary retention, local anesthetic systemic toxicity,local hematoma ).
3.Hemodynamic response to surgical stimulus during the procedure(HR,SPO2,NIBP at baseline ,post intubation,proning,30 min,1 hr into surgery). 
1.At the time of arrival in post-anesthesia care unit and then at 30 minutes, 1, 2, 4, 6, 12,24 and 48 hours after operation. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/05/2025 
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="3"
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  

After spine surgery, postoperative pain could be moderate to severe for more than half of patients.Surgical trauma, neuropathy and inflammation are factors contributing to this.Erector spinae plane block is fascial plane block used widely for post operative analgesia of spine surgeries.This involves injecting a local anesthetic into the plane between the erector spinae muscle and the transverse process of the vertebra. The local anesthetic spreads on a plane caudally and cranially, allowing the sympathetic nerve fibers, as well as the spinal nerves’ dorsal and ventral rami to be blocked.Direct injection of morphine into the intrathecal space also allows to directly act on opioid receptors within the brain and substantia gelatinosa of the spinal cord resulting in a robust analgesia after spine surgeries.

The current study aimed to assess and compare the efficacy and safety of intrathecal morphine with erector spinae plane block in patients undergoing elective lumbar spine surgeries.A total of 100 patients aged between 18 and 65 years of either sex will be selected from the patients posted for elective lumbar spine surgery. Patients will be divided into two groups: Group A patients will receive 0.2 mg intrathecal morphine at any one space between L2-L5 level and Group B will receive bilateral erector spinae plane block at Lumbar level L1-L5  by using 40 mL of 0.25 % bupivacaine before starting the surgery for postoperative analgesia. In the perioperative period, pain will be assessed by hemodynamic parameters (heart rate and mean arterial pressure,SpO2), visual analogue scale and patient satisfaction score. Time to first rescue analgesic requirement and incidence of any adverse events will also be noted.


 
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