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CTRI Number  CTRI/2024/11/076170 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 24/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the pain relief of two techniques (regional anaesthetic) after surgery (decompression) on lower vertebral column (lumber). 
Scientific Title of Study   Comparison of Retrolaminar block and Erector spinae plane block for post-operative analgesia in patients undergoing lumbar spine decompression surgery A prospective randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sadik Mohammed 
Designation  Additional Professor  
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS Jodhpur 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sadik Mohammed 
Designation  Additional Professor  
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS Jodhpur 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  9414849733  
Fax    
Email  drmsadik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anju Raja 
Designation  Junior Resident  
Affiliation  Department of Anaesthesiology and Critical Care, AIIMS Jodhpur 
Address  Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences (AIIMS), Marudhar Industrial Area, Phase II, Basni, Jodhpur.

Jodhpur
RAJASTHAN
342005
India 
Phone  8003579818  
Fax    
Email  dranjuraja.22@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan. (India) 342005 
 
Primary Sponsor  
Name  AIIMS JODHPUR 
Address  All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur, Rajasthan. (India) 342005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sadik Mohammed  AIIMS JODHPUR  Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India Institute of Medical Sciences (AIIMS), Phase II, Basni Industrial Area, Jodhpur.
Jodhpur
RAJASTHAN 
09414849733

drmsadik@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Erector spinae plane block   All patients will receive ultrasound guided B/L Erector spinae plane block with 15 ml 0.375% Ropivacaine on either side and will be followed for analgesia using Numeric rating score for first 24 hours in the postoperative period. 
Intervention  Retrolaminar Block  All Patients will receive ultrasound guided B/L Retrolaminar block with 15 ml 0.375% Ropivacaine on either side and will be followed for analgesia using Numeric rating score for first 24 hours in the postoperative period.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Adult Patients of either sex, aged between 18 to 65 years, belonging to ASA physical status 1 or 2, and scheduled for elective lumbar spine decompression surgery.  
 
ExclusionCriteria 
Details  1. Pregnant or lactating female.
2. History of bleeding diathesis or receiving anticoagulant treatment.
3. Skin infection at the site of the block area.
4. Patients with baseline cognitive deficits sufficient to make objective pain assessment unreliable.
5. Opioid-dependent or chronic analgesic abuse.
6. Patients with known allergy to amide local anaesthetic or opioid. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of our study will be to compare postoperative pain score using Numeric Rating Scale (NRS) in GROUP RLB & GROUP ESPB.  During the first 24 hours after surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare the time to first rescue analgesic requirement.
2. To compare total analgesic consumed during the first 24 hrs after surgery.
3. To compare the intraoperative analgesic consumption.
4. To assess patient satisfaction score using Likert’s scale of both techniques.
5. To compare the side effects of both techniques.
 
During the first 24 Hours in the Postoperative period  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   20/11/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drmsadik@gmail.com].

  6. For how long will this data be available start date provided 01-10-2027 and end date provided 30-09-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Surgical procedures on the spine often result in significant postoperative pain, with inadequate pain control affecting recovery and increasing chronic pain risk. Traditionally, opioids have been used for pain management, but ERAS protocols encourage a multimodal approach to reduce opioid reliance. Regional anesthesia techniques, particularly peripheral nerve blocks like the erector spinae plane (ESP) block and retrolaminar (RL) block, are gaining attention for their effectiveness and fewer side effects compared to neuraxial methods. The ESP block targets spinal nerve rami and sympathetic nerves, while the RL block focuses on dorsal rami. Both techniques have shown promise in reducing pain and opioid consumption, but more comparative studies are needed to determine the best option for postoperative analgesia in spine surgery. 

In the present study, patients will be randomly assigned to receive either a Retrolaminar block (RL) or an Erector Spinae Plane block (ES). Patients will undergo routine evaluations and fasting protocols. In the operating room, ASA standard monitors will be attached, induction of anesthesia will be performed, and the allocated block will be performed using ultrasound guidance after placing the patients in the surgical position (prone).

Group ‘RLB’ (Retrolaminar Block )- All patients will receive ultrasound (US) guided Retrolaminar block with 15 mL of 0.375% Ropivacaine on either side.

Group ‘ESPB’(Erector Spinae Plane Block)-All patients will receive ultrasound guided Erector Spinae Plane Block with 15 ml of 0.375% Ropivacaine on either side.

Block performance time, number of attempts, and complications will be recorded. Anesthesia maintenance will include isoflurane and rocuronium, with intraoperative analgesia provided by fentanyl and paracetamol. Postoperative pain will be assessed using a numerical rating scale (NRS), and rescue analgesia will be administered as needed. Side effects and patient satisfaction will also be documented throughout the study period.

 
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