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CTRI Number  CTRI/2024/07/070046 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Prolongation of pain relief after injection of two drugs, dexamethasone and dexmedetomidine mixed with local anaesthetic above lamina of spine : a comparative study in patients of spine surgeries. 
Scientific Title of Study   Comparison of analgesic efficacy of dexamethasone and dexmedetomidine as adjuvants to ropivacaine in ultrasound guided retrolaminar block for adult patients undergoing thoracolumbar spine surgery: a 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  Dr Aakanksha Hiremath 
Designation  Academic Junior Resident  
Affiliation  AIIMS Patna 
Address  Room no 13, OPD Ground Floor Department of Anaesthesiology AIIMS Patna Bihar

Patna
BIHAR
801507
India 
Phone  9811192382  
Fax    
Email  aakanksha.hiremath@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Amarjeet Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Patna 
Address  Room No. 505, IPD 5th Floor Department of Anaesthesiology AIIMS Patna Bihar

Patna
BIHAR
801507
India 
Phone  9570890646  
Fax    
Email  amarjeetdmch@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aakanksha Hiremath 
Designation  Academic Junior Resident 
Affiliation  AIIMS Patna 
Address  Room no 13, OPD Ground Floor Department of Anaesthesiology AIIMS Patna Bihar

Patna
BIHAR
801507
India 
Phone  9811192382  
Fax    
Email  aakanksha.hiremath@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology, 5th floor IPD AIIMS Patna Bihar-801507 India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Patna 
Address  Department Of Anaesthesiology IPD 5th Floor AIIMS Patna, Bihar-801507 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Aakanksha Hiremath  AIIMS Patna  Department of Anaesthesiology 5th Floor IPD building AIIMS Patna
Patna
BIHAR 
9811192382

aakanksha.hiremath@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Patna  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  Retrolaminar block with 0.2% ropivacaine and adjuvant dexmedetomidine  Retrolaminar block using 0.2% ropivacaine 20 ml and 1mcg/kg dexmedetomidine injected bilaterally at the level of target vertebrae situated in the middle of skin incision. (total volume will be 40 ml) 
Intervention  Retrolaminar block with 0.2% ropivacaine with adjuvant dexamethasone  Retrolaminar block using plain 0.2% ropivacaine 20 ml and 4mg dexamethasone injected bilaterally at the level of target vertebrae situated in middle of skin incision. (total volume will be 40 ml) 
Comparator Agent  Retrolaminar block with 0.2% ropoivacaine alone  Retrolaminar block using plain 0.2% ropivacaine 20 ml injected bilaterally at the level of target vertebrae situated in middle of skin incision. (total volume will be 40 ml) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I and II patients undergoing thoracolumbar spinal surgeries less than or equal to five segments.
 
 
ExclusionCriteria 
Details  ASA III or more
Allergy to the drugs
Coagulopathy
Infection at puncture site
Mental disorder, Communication failure, unable to discriminate
cutaneous pin prick.
Chronic use of analgesics, inability to operate PCA pump
Preexisting spinal cord disease prior lumbar spine surgery
BMI more than or equal to 30 
 
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 
To compare the time to first rescue analgesic requirement in postoperative period.
 
Within 24 hours of postoperative period
 
 
Secondary Outcome  
Outcome  TimePoints 
Total postoperative fentanyl consumption   within 24 hours of postoperative period 
To evaluate additional intraoperative fentanyl consumption in all groups.  From administration of block till the end of surgery 
Severity of pain during postoperative period
measured through NRS scale 
1,2, 4, 6, 12, 24 hours 
 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

In the landscape of thoracolumbar spine surgeries, effective perioperative pain management stands as a pivotal element in controlling post operative pain and optimizing pain relief allowing for early ambulation and decreased hospital stay. A wide of number of regional analgesia techniques have been utilised to manage this pain like paravertebral blocks, epidural blocks and interfascial blocks like erector spinae plane block.

Retrolaminar block (RLB) is a novel interfacial plane block which has been used to provide perioperative analgesia in patient undergoing lumbar surgeries, breast surgeries, nephrectomy, thoracotomy and in retroperitoneal laproscopic surgeries.  In all of these studies only local anaesthetic (bupivacaine or ropivacaine) was used. These local anaesthetics have limited duration of action typically, around 10 hours.  Several drugs (opioids, dexamethasone) have been used as adjuvants to local anaesthetics to prolong the duration of analgesia in erector spinae plane block for spine surgeries.

However, the efficacy of these adjuvants has not been established in retrolaminar plane blocks. Our study aims to determine the benefits of adding dexmedetomidine or dexamethasone as adjuvant to ropivacaine in prolonging the duration of postoperative analgesia, improve postoperative pain score and patient satisfaction.

 
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