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CTRI Number  CTRI/2019/02/017736 [Registered on: 20/02/2019] Trial Registered Prospectively
Last Modified On: 19/02/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Effect of adding dexmedetomidine to local anaesthetic wound infiltration for post surgery pain relief 
Scientific Title of Study   The effect of dexmedetomidine as an adjuvant to ropivacaine for wound infiltration in providing postoperative analgesia for open abdominal surgeries. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sumadhu 
Designation  PG 
Affiliation  Sri venkateswara institute of medical sciences 
Address  Department of anaesthesiology,SVIMS University,Tirupathi

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9177704349  
Fax    
Email  sumadhu13121991@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Aloka Samantaray 
Designation  Professor and head of the department 
Affiliation  Sri venkateswara institute of medical sciences 
Address  Department of anaesthesiology,SVIMS,Tirupathi

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aloka Samantaray 
Designation  Professor and head of the department 
Affiliation  Sri venkateswara institute of medical sciences 
Address  Department of anaesthesiology,SVIMS,Tirupathi

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara institute of medical sciences,Alipiri road,Tirupathi,517507,Andhra Pradesh,India 
 
Primary Sponsor  
Name  Svims 
Address  SVIMS, Alipiri road,Tirupathi,Chittoor 
Type of Sponsor  Research institution 
 
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 
DrSumadhu  svims  Department of Anesthesiology, Sri venkateswara institute of medical sciences, Tirupati, Andhra Pradesh, INDIA
Chittoor
ANDHRA PRADESH 
9177704349

sumadhu13121991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Tramadol and Fentanyl  post-operatively if Numerical Rating Scale (NRS)Score 4, patients will be prescribed inj.Tramadol 2mg/kg intravenously followed by additional doses if requested by patient after an interval of 12 hours. pain between 2 doses of tramadol will be treated with inj.fentanyl 0.5mcg/kg intravenously.NRS Score will be assessed at 0hr,2hr,4hr,6hr,12hr&24hr. 
Comparator Agent  Two different doses of Dexmedetomidine with ROpivacaine  patients will be divided into three groups to recieve different doses of Dexmeditomedine(Group R will recieve Normal saline,Group RD1 will recieve 0.5mcg/kg Dexmeditomedine & Group RD2 will recieve 1mcg/kg Dexmeditomedine) along with 30 ml of 0.75% Ropivacaine for Wound infiltration.The total drug volume will be made to 60ml with Normal Saline and will be infiltrated by the surgeon into the surgical wound edges ONE time at the end of surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients scheduled to undergo elective open abdominal surgeries at SVIMS.
2.Patients belonging to ASA physical status 1,2 and 3.
3.Age group between 18 and 65 years.
 
 
ExclusionCriteria 
Details  1.Patient refusal to participate in the study.
2.Severe hepatic/cardiac/renal disorders.
3.Pre existing neurological deficits/psychiatric illness/metabolic disorders.
4.Allergic reaction to the study drugs.
5.History of chronic analgesic usage(on oral analgesics for more than one month).
6.Pregnant and lactating mothers.
7.Patients who cannot understand and interpret NRS.
 
 
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 
The magnitude of pain using NRS at fixed time interval   At 0hr,2hr,4hr,6hr,12hr&24hr. 
 
Secondary Outcome  
Outcome  TimePoints 
Analgesic requirement in first 24 hours after surgery.
The time to the first request of rescue analgesia.
 
6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 1 
Date of First Enrollment (India)   21/02/2019 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

An incision made in the abdominal wall contributes to severe postoperative pain which may cause the decreased function of the immune system, decreased healing and painful suffering, these changes may probably negatively affect the postoperative recovery pain.

            Wound infiltration with local anesthetics is one of the multimodal approaches to control postoperative pain after open abdominal surgeries.

Ropivacaine is a long-acting amide– local anesthetic, s-enantiomer mainly used for surgery and postoperative pain relief.4 At high doses, it produces surgical anesthesia and at lower doses, it produces analgesia mainly sensory block with a limited and non-progressive motor block. Ropivacaine has a slightly prolonged duration of action than bupivacaine and less cardiotoxic effects.

Dexmedetomidine is a strong and highly selective α2-adrenoreceptor agonist which has sedative, analgesic, and sympatholytic properties. It enhances the analgesic efficacy of local anesthetics when added as an adjuvant for wound infiltration.

            Different doses of dexmedetomidine has been tried as adjuvant to local anaesthetics to prolong post operative analgesia.6,7,8However the optimum dose of dexmedetomidine is yet to be 


 
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