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CTRI Number  CTRI/2024/05/068224 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 24/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Trial Comparing The Efficacy Of Combination Of Low Dose Of Dexmedetomidine And Bupivacaine 0.0625% With Plain Bupivacaine 0.125% In Postoperative Pain Management And Recovery In Abdominal And Lower Limb Surgeries 
Scientific Title of Study   An Open Label Randomised Trial Comparing Low Dose Of Dexmedetomidine As An Adjuvant To Isobaric Bupivacaine 0.0625% In Comparison With Plain Bupivacaine 0.125% To Assess Quality Of Postoperative Analgesia And Recovery In Abdominal And Lower Limb Surgeries 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nayana Sabu 
Designation  Junior Resident 
Affiliation  AIIMS NAGPUR 
Address  Department of Anaesthesiology And Critical Care First Floor IPD Building AIIMS Nagpur Mihan

Nagpur
MAHARASHTRA
441108
India 
Phone  8848087592  
Fax    
Email  nayana0016@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Nayana Sabu 
Designation  Junior Resident 
Affiliation  AIIMS NAGPUR 
Address  Room No 8,Resident Doctor Room, Department of Anaesthesiology And Critical Care First Floor IPD Building AIIMS Nagpur Mihan

Nagpur
MAHARASHTRA
441108
India 
Phone  8848087592  
Fax    
Email  nayana0016@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nayana Sabu 
Designation  Junior Resident 
Affiliation  AIIMS NAGPUR 
Address  Department of Anaesthesiology And Critical Care First Floor IPD Building AIIMS Nagpur Mihan

Nagpur
MAHARASHTRA
441108
India 
Phone  8848087592  
Fax    
Email  nayana0016@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  Nayana Sabu 
Address  Department Of Anaesthesiology And Critical Care First Floor IPD Building AIIMS Nagpur Mihan 
Type of Sponsor  Other [Self ] 
 
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 Nayana Sabu  AIIMS Nagpur  Department of Anaesthesiology And Critical Care,1st Floor, IPD building
Nagpur
MAHARASHTRA 		 8848087592

nayana0016@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee Department Of Pharmacology AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BUPIVACAINE  0.125% BUPIVACAINE infusion for 24 hours 
Intervention  DEXMEDETOMIDINE And BUPIVACAINE  0.5 mcg/kg DEXMEDETOMIDINE And 0.0625% BUPIVACAINE for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Abdominal and lower limb surgeries
ASA grade 1 and 2
Adults
 
 
ExclusionCriteria 
Details  Bleeding disorders and coagulopathies
Pregnancy
raised ICT
Altered sensorium
Preexisting Bradycardia
Hypotension
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Quality of analgesia using subjective tool-VAS scale and objective pain assessment tool- salivary alpha amylase level  0 HR
1 HR
2 HR
6 hr
12 hr
24 hr
 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic instability(pulse rate, mean arterial BP ,respiratory rate, Ritchmond Almond Sedation scale ,spo2)  0 hr ,2 hrs ,6 hrs , 12 hrs, 24hrs 
Degree Of Motor Block  0 hr
2 hr
6 hr
12 hr
24 hr
 
Incidence of adverse effects  Upto 24 hrs 
Requirement Of Rescue Analgesic  upto 24 hours 
 
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 2 
Date of First Enrollment (India)   24/06/2024 
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="30" 
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  
This thesis focuses on addressing post-operative pain management, recognizing its critical role in
preventing adverse outcomes such as elevated blood pressure, delayed recovery, increased risk of
chronic pain, and post-traumatic stress disorder (PTSD). Departing from conventional opioid use
due to associated adverse effects, the study introduces a novel approach involving
dexmedetomidine, a non-opioid adjuvant, in epidural analgesia.
Epidural analgesia is chosen for its advantages, including early mobilization, accelerated
recovery of gastrointestinal function, and reduced pulmonary and cardiovascular morbidity. The
primary aim of the study is to compare postoperative analgesia achieved through epidural
infusion of dexmedetomidine as an adjunct to low-dose isobaric bupivacaine versus the
conventional dose of plain isobaric bupivacaine. The primary objective is to assess the quality of
analgesia using subjective and objective pain assessment tools.The secondary objectives include
evaluating hemodynamic stability, degree of motor blockade, and the incidence of adverse
effects.
The maximum sample size that could be obtained based on VAS score, using the formula of
Mean Difference, power of 80%, two-sided confidence interval of 95% and using the 48 hour
VAS-R score from the parent study is n = 29 and 25 is the minimum number per group.
Two treatment arms are established, involving different combinations of bupivacaine and
dexmedetomidine, and randomization is achieved through a block randomization technique.
Patient inclusion criteria focus on ASA grade 1 and 2 individuals aged 18-60 undergoing specific
surgeries, while exclusion criteria encompass various conditions, including bleeding disorders
and coagulopathies. The study timeline spans over 18 months, including approval from the
Institutional Ethics Committee, preparation of study tools, a pilot study, data collection, analysis,
interpretation, and submission of the thesis. Ethical considerations underscore the importance of
informed, written, and verbal consent, as well as the option for participants to opt out at any
point in the study. Overall, the research aims to enhance postoperative pain relief while
minimizing adverse effects, contributing valuable insights to the field of anesthesia and pain
management.
 
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