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CTRI Number  CTRI/2024/02/062748 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 14/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison between dexmedetomidine and dexamethasone to levobupivacaine in erector spinae block for renal surgeries under general anaesthesia. 
Scientific Title of Study   COMPARISON OF DEXMEDETOMIDINE VS DEXAMETHASONE AS ADJUVANTS TO LEVOBUPIVACAINE IN ULTRASOUND GUIDED ERECTOR SPINAE BLOCK FOR PATIENTS UNDERGOING RENAL SURGERIES UNDER GENERAL ANAESTHESIA- A RANDOMISED CONTROLLED STUDY  
Trial Acronym  A RANDOMISED CONTROLLED STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr.Bhumika Pathak 
Designation  Professor  
Affiliation  Pramukh swami medical college  
Address  Room No. 112,Department of anaesthesiology ,Shree krishna hospital, Pramukh swami medical college, karamsad ,anand .
shree krishna hospital , Bhaikaka University, karamsad , Anand.
Anand
GUJARAT
388325
India 
Phone  9904438877  
Fax    
Email  docbhum29@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Bhumika Pathak 
Designation  Professor  
Affiliation  Pramukh swami medical college  
Address  Room No. 112,Department of anaesthesiology shree krishna hospital , Pramukh swami medical college ,karamsad ,anand.
shree krishna hospital, Bhaikaka University, karamsad , anand.
Anand
GUJARAT
388325
India 
Phone  9904438877  
Fax    
Email  docbhum29@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Radhika Rajendrabhai Rajyaguru 
Designation  second year resident anaesthesiology  
Affiliation  Pramukh swami medical college and hospital  
Address  Room No 112 , Department of anaesthesiology, shree krishna hospital .
Bhaikaka university ,karamsad ,anand
Anand
GUJARAT
388325
India 
Phone  9106615288  
Fax    
Email  radhikarajyaguru6@gmail.com  
 
Source of Monetary or Material Support  
SHREE KRISHNA HOSPITAL ,PRAMUKH SWAMI MEDICAL COLLEGE, BHAIKAKA UNIVERSITY ,KARAMSAD,ANAND ,GUJARAT 
 
Primary Sponsor  
Name  SHREE KRISHNA HOSPITAL 
Address  SHREE KRISHNA HOSPITAL,PRAMUKH SWAMI MEDICAL COLLEGE , GOKAL NAGAR,BHAIKAKA UNIVERSITY,KARAMSAD ,ANAND 
Type of Sponsor  Private medical college 
 
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 Bhumika Pathak  Shree Krishna Hospital  Pramukhswami Medical College, Bhaikaka university,karamsad ,Anand
Anand
GUJARAT 
9904438877

docbhum29@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee-2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N23||Unspecified renal colic,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  inj Dexamethasone with inj Levobupivacaine   Erector spinae block with Inj Levobupivacaine 30ml with Inj Dexamethasone 0.1mg/kg as adjuvant . 
Intervention  Inj Dexmedetomidine with inj Levobupivacaine  Erector spinae block with inj Levobupivacaine 30ml with inj Dexmedetomidine 0.5mcg/kg as adjuvant 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients undergoing Renalsurgeries under general anaesthesia.
2.Aged 18 to 60 years
3.American Society of Anesthesiologists Physical Status grade I-III 
 
ExclusionCriteria 
Details  Patient refusal. patient with ASA IV and V 
 
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 postoperative analgesia in dexmedetomidine and dexamethasone group.  immediate post-op 0 hour, 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and
24hours(H24). 
 
Secondary Outcome  
Outcome  TimePoints 
Assess and compare the time for 1st rescue analgesia
Assess and compare the occurrence of hemodynamic changes in both the groups
Total consumption of rescue analgesics 
immediate post-op (0hr), 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and
24hours(H24). 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
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   N/A 
Date of First Enrollment (India)   25/02/2024 
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 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 obtaining ethics committee approval and written informed consent, patients undergoing renal surgeries (both laparoscopic renal surgeries and open renal surgeries) under general anesthesia will be recruited in this study. Participants will be randomly allotted in to two groups. A computer
software WINPEPI will be used for the randomization. The random allocation will be kept in a sealed opaque envelops and they will be opened after written informed consent of eligible participants. Routine detailed Pre-anesthesia check- up will be carried out in all patients. On arrival to operation theatre, standard monitoring- electrocardiogram (ECG), pulse oximetry (SPO2) and non-invasive blood pressure (NIBP), End tidal Carbon Dioxide (ETCO2) monitoring will be attached and baseline vitals will be noted. Under all aseptic precautions ultrasound guided erector spinae block will be performed using linear probe (0.5-6 MHz) in sitting position at T10 level for renal surgeries. After visualizing transverse process at T10 level and erector spinae muscle, study drug will be injected in the fascial planes between transverse process of T10 vertebrae and erector spinae muscle. As per randomization, Patients in group-A will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg (IBW)) with injection dexamethasone (0.1mg/kg) as per ideal body weight (IBW) and in group-B patients will receive inj. levobupivacaine 0.25% 30ml (max dose 2mg/kg(IBW)) with injection dexmedetomidine 0.5mcg/kg in erector spinae block. Block will be performed either by anesthesia consultants or by 3rd year residents under supervision of anesthesia consultants.
 General anesthesia will be started by preoxygenating patient with 100% oxygen via closed circuit manual ventilation. Premedication’s will be given starting with Inj. glycopyrrolate (0.004mg/kg), inj. fentanyl (0.5- 2mcg/kg), in.j midazolam (0.1- 0.2mg/kg), inj. lignocaine (0.5-1mg/kg ) for blunting stress responses during intubation .Patient will be induced using Inj. propofol( 2mg/kg ) followed by check ventilation .Adequate muscle relaxation will be achieved with inj. succinylcholine 1mg/kg or inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg . Patient will be intubated using conventional laryngoscope, long acting muscle relaxation will be achieved with inj. atracurium 0.5mg/kg or inj. vecuronium 1mg/kg. Patient is maintained on closed circuit controlled mechanical ventilation on oxygen +air +sevoflurane/Desflurane with bolus doses of muscle relaxant. Constant monitoring of hemodynamic parameters (Heart rate, blood pressure) and blood loss monitoring will be done . Postoperatively Post-operatively, the pain will be monitored using the visual analogue score (VAS) at rest and on deep breathing at times zero (H0), 1 hour (H1), 2 hours (H2), 4 hours (H4), 6 hours (H6), 12 hours (H12), 18 hours (H18) and 24hours(H24). If VAS ≥4 , rescue analgesia using Inj. tramadol 0.5mg/kg will be given. In case of persistent pain Inj. Tramadol 0.5mg/kg or inj. fentanyl 0.5mcg/kg will be given 6 hourly . Postoperatively patient’s overall recovery will be assessed using Quality of Recovery 40 questionnaire (QoR 40) .This questionnaire is available in public domain and it is been translated and back-translated into vernacular language by two different linguists. Any intraoperative or post operative side effects (like nausea, vomiting, giddiness ,Tingling numbness , hypotension, bradycardia) will be noted. Postoperatively side effects will be managed by the following: 1. Vomiting will be managed by giving inj ondansetron 0.1mg/kg 2. Hypotension is systolic blood pressure <20% of the baseline , Intravenous fluids like ringers lactate will be given, in case of persistent hypotension Inj mephentermine 0.1mg/kg will be administred. 3. Bradycardia is heart rate <20% of baseline ,Inj atropine 0.6mg will be given. 4. Tingling and numbness are transient effects and it will be observed for the same
 
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