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CTRI Number  CTRI/2025/06/088250 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 27/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare postoperative analgesic efficacy after infiltrating Bupivacaine with Dexmedetomidine vs Bupivacaine alone at surgical incision site in below umbilical surgeries. 
Scientific Title of Study   A Comparative study of postoperative analgesic efficacy after infiltrating Bupivacaine with Dexmedetomidine vs Bupivacaine alone at surgical incision site in below umbilical 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  PUNIT KUMAR 
Designation  PG JR2 Department of Anaesthesiology Sth and Gmch 
Affiliation  Government Medical College And Sth, Haldwani 
Address  Department Of Anaesthesiology, Critical Care,Pain and Palliative Medicine,2nd Floor Susheela Tiwari Hospital, Haldwani

Nainital
UTTARANCHAL
263139
India 
Phone  9759889895  
Fax    
Email  drpuneetk007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR AJAY KUMAR SINHA 
Designation  Professor And Hod Of Anaesthesiology 
Affiliation  Government Medical College And Sth, Haldwani 
Address  Department Of Anaesthesiology, Critical Care,Pain And Palliative Medicine, Susheela Tiwari Government Hospital, Haldwani Uttarakhand 263139

Nainital
UTTARANCHAL
263139
India 
Phone  9897672301  
Fax    
Email  drajayksinha@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR AJAY KUMAR SINHA 
Designation  Professor and Hod Department of Anaesthesiology 
Affiliation  Government Medical College And Sth, Haldwani 
Address  Department Of Anaesthesiology,Critical Care,Pain and Palliative Medicine Susheela Tiwari Government Hospital Haldwani Nainital Uttarakhand 263139

Nainital
UTTARANCHAL
263139
India 
Phone  9897672301  
Fax    
Email  drajayksinha@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Critical care, Pain and palliative Medicine, Susheela Tiwari government hospitals,Haldwani, Nainital, Uttarakhand 263139. 
 
Primary Sponsor  
Name  Dr Punit kumar 
Address  Department of anaesthesiology, critical care, Pain and palliative medicine, Susheela Tiwari govt hospital Haldwani Uttarakhand 263139 
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 Punit Kumar  Susheela tiwari government hospital  Department of Anaesthesiology, Critical care, Pain and Palliative Medicine , Susheela tiwari government hospital Haldwani, Nainital, Uttarakhand 263139
Nainital
UTTARANCHAL 		 9759889895

drpuneetk007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, GMC, Haldwani  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, (2) ICD-10 Condition: K35-K38||Diseases of appendix, (3) ICD-10 Condition: K40-K46||Hernia, (4) ICD-10 Condition: K60||Fissure and fistula of anal and rectal regions, (5) ICD-10 Condition: K61||Abscess of anal and rectal regions, (6) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, (7) ICD-10 Condition: N20-N23||Urolithiasis, (8) ICD-10 Condition: N40||Benign prostatic hyperplasia, (9) ICD-10 Condition: N43||Hydrocele and spermatocele, (10) ICD-10 Condition: N47||Disorders of prepuce, (11) ICD-10 Condition: N45||Orchitis and epididymitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bupivacaine  The study population is divided into 2 groups of 74 patients receiving 20mL 0.25% bupivacaine with normal saline 0.5ml for surgical incision 
Comparator Agent  Bupivacaine with dexmedetomidine  The study population is divided into 2 groups of 74 patients receiving 20mL 0.25% bupivacaine with 0.5 ml (50mcg) dexmedetomidine for surgical incision. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Patients giving informed consent to participate in the study.
2.All patients posted for below umbilicus surgeries.
3.Age of the patient between 18-50 years.
4.Patients belonging to ASA I & ASA II 
 
ExclusionCriteria 
Details  1.Patients with morbid obesity
2.Patients with Raynaud’s disease
3.Patients belonging to ASA class III and IV.
4.Patients with co morbidities
5.Patients with infection at the site of infiltration.
6.Patients with psychiatric disorders.
7.Patients with history of hypersensitivity to any of the drugs under study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the duration of postoperative analgesia after local infiltration in both groups, Bupivacaine alone and Bupivacaine mixed with Dexmedetomidine  at 5 minutes, 30 minutes, 45 minutes, 75 minutes, 90 minutes, 2hour, 4 hour, 6 hour, 12 hour, 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To calculate the total amount of rescue analgesic consumed in 24 hours  at 3 hour, 6 hour, 12 hour, 24 hour 
To observe VAS score after infiltration  at 5 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 2 hour, 4 hour, 6 hour, 12 hour, 24 hour 
To observe the hemodynamic changes after local infiltration of Dexmedetomidine added to Bupivacaine at incision site  at 15 minutes, 30 minutes, 45 minutes, 60 minutes, 3 hour, 6 hour, 9 hour, 12 hour, 16 hour, 20 hour, 24 hour 
 
Target Sample Size   Total Sample Size="148"
Sample Size from India="148" 
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)   07/06/2025 
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   This study is a prospective, interventional, randomized comparison of the postoperative analgesic effect of bupivacaine with dexmedetomidine versus bupivacaine alone for local infiltration at the surgical incision site in infraumbilical surgeries. A total of 148 patients aged 18 to 50 years undergoing infraumbilical surgeries were randomly divided into two groups. Group DB received 20 mL of 0.25 percent bupivacaine with 50 mcg dexmedetomidine, and Group PB received 20 mL of 0.25 percent bupivacaine with 0.5 mL normal saline. The study assessed duration of analgesia, total rescue analgesic requirement in 24 hours, VAS pain scores, and hemodynamic changes. Pain was measured using the Visual Analogue Scale at regular intervals and rescue analgesia was administered if the VAS score was 4 or more. Hemodynamic parameters were monitored, and data were analyzed using standard statistical methods. 
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