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CTRI Number  CTRI/2025/02/081474 [Registered on: 28/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
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   Comparing the post operative analgesic effectiveness of bupivacaine-dexmedetomidine versus bupivacaine-fentanyl combination in thoracic epidural for midline laparotomies. 
Scientific Title of Study   Post Operative Analgesic Efficacy of Dexmedetomidine V/S fentanyl as an Adjuvant to Bupivacaine in Thoracic Epidural for Midline Laparotomies 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shikha Gupta  
Designation  PG 3rd year anaesthesia resident  
Affiliation  Sardar Patel Medical College  
Address  Department of anaesthesia, Sardar Patel Medical College, PBM Hospital, Bikaner, Rajasthan (334001)

Bikaner
RAJASTHAN
334001
India 
Phone  8307568668  
Fax    
Email  Shikhashiv279@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kiwi Mantan 
Designation  Associate Professor  
Affiliation  Sardar Patel Medical College  
Address  Department of anaesthesia, Sardar Patel Medical College, PBM Hospital, Bikaner, Rajasthan (334001)

Bikaner
RAJASTHAN
334001
India 
Phone  9929092702  
Fax    
Email  kiwivyas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kiwi Mantan  
Designation  Associate Professor  
Affiliation  Sardar Patel Medical College  
Address  Department of anaesthesia, S.P. Medical College, Bikaner, Rajasthan 334001

Bikaner
RAJASTHAN
334001
India 
Phone  9929092702  
Fax    
Email  kiwivyas@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical College, SP medical college road, Sardar Patel colony, Bikaner, Rajasthan 334001  
 
Primary Sponsor  
Name  Sardar Patel Medical College Bikaner Rajasthan  
Address  Department of Anaesthesia, Sardar Patel Medical College, Bikaner, Rajasthan  
Type of Sponsor  Government 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 Kiwi Mantan   Sardar Patel Medical College   Department of Anaesthesiology OT-A block PBM hospital, Sardar Patel Medical College, Bikaner
Bikaner
RAJASTHAN 
9929092702

kiwivyas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical and Research Board, Sardar Patel Medical College, Bikaner, Rajasthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic), (2) ICD-10 Condition: K566||Other and unspecified intestinal obstruction, (3) ICD-10 Condition: K46||Unspecified abdominal hernia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Post operative analgesic efficacy of dexmedetomidine versus fentanyl as an adjuvant to bupivacaine in thoracic epidural for midline laparotomies   Under all aseptic conditions, an epidural catheter was inserted via 16 G or 18 G Toheys needle using LOR technique and secured at the level of T8-T9, T9-T10 or T10-T11 interspace in the patients posted for midline laparotomies. A combination of 10 mL of 0.25% bupivacaine with 0.5 mL of dexmedetomidine (50 mcg) and 0.5 mL of 0.9% NS was given epidurally in one group of patients. In another group of patients, a combination of 10 ml of 0.25% bupivacaine with 1 ml of fentanyl (50 mcg) was given via epidural route. Both the drugs were given epidurally within 10 minutes of intubation. Duration of post operative analgesia was assessed using numerical rating scale. 
Intervention  Thoracic epidural for post operative analgesic efficacy in midline laparotomies   Under all aseptic conditions, an epidural catheter was inserted via 16 G or 18 G Toheys needle using LOR technique and secured at the level of T8-T9, T9-T10 or T10-T11 interspace in midline laparotomies. Study drug was given via epidural route within 10 minutes of intubation. Duration of post operative analgesia was assessed using Numerical Rating Scale.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients in age group 18-70 years. 2. Posted for elective laparotomy. 3. BMI 18-30 Kg/m2. 4. ASA grade I, II, III. 
 
ExclusionCriteria 
Details  1. Patient refusal. 2. Known allergy to drug used in the study. 3. Patient with ASA grade IV and above. 4. Pre-existing intrinsic or idiopathic coagulopathy. 5. Hepatic, renal or cardiorespiratory failure. 6. Patients with an increase in intracranial pressure.
7. Skin or soft tissue infection at the proposed site of needle insertion.
8. Severe hypovolemia.
9. Pre-existing neurological disease.
10. Emergency laparotomy surgeries.
11. Surgeries lasting for more than 3 hrs. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare dexmedetomidine and fentanyl as an adjuvant for bupivacaine in thoracic epidural in terms of duration of post operative analgesia in first 24 hours.  Evaluate on the basis of NRS score at different intervals in first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Peri-operative hemodynamic stability
2. Post-operative sedation score
3. Side effects and complications related to drugs and procedure. 
1. Intra-operative heart rate, SBP, DBP, MAP, spO2 before intubation, thoracic epidural analgesic given(T0), 5 min, 10 min, 15 min, 30 min, 1 hour, 1 hour 30 min, 2 hours, 2 hour 30 min, 3 hours, immediate post intubation.
2. Post operative heart rate, SBP, DBP, MAP, spO2 in the first 24 hours 30 mins, 1 hour, 2 hours, 3 hours, 6 hours, 9 hours, 12 hours, 18 hours and 24 hours.
3. Post operative sedation score in first 24 hours 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   10/03/2025 
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="0"
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   Large surgical incisions and extensive gut handling and manipulation are involved with upper abdominal surgeries which increases the need for perioperative analgesia. Uncontrolled postoperative pain and pathophysiological response to surgery make these patients prone to high stress and sympathetic activation.
Epidural analgesia is a simple and safe technique that produces effective block with small dose of local anaesthetic. It provides extended post-operative pain control that is superior to that provided by systemic opioids alone. Thoracic epidural analgesia (TEA) provides good postoperative pain relief and facilitates deep breathing exercises and early ambulation. Sympathetic outflow decreases with use of TEA. To achieve desired post-op analgesic effect, invariably large volumes of local anaesthetics are used, thereby increasing the possibilities of local anaesthetic toxicity and deleterious hemodynamic consequences. Opioids like fentanyl have been used traditionally as an adjunct for epidural administration in combination with a lower dose of local anaesthetic to achieve the desired analgesic effect. The addition of opioid does provide a dose sparing effect of local anaesthetic and superior analgesia but there is always a possibility of an increased incidence of nausea, vomiting and respiratory depression. 
Dexmedetomidine is an alpha-2 agonist which has got numerous beneficial effects. It acts on both pre and post synaptic sympathetic nerve terminal and central nervous system thereby decreasing the sympathetic outflow and nor-epinephrine release. Dexmedetomidine has an effective sedative, anti-anxiety and analgesic effect. Dexmedetomidine does cause a manageable hypotension and bradycardia but it does not cause opioid related side effects like respiratory depression, nausea and vomiting.
Therefore, we planned to compare the post operative analgesic efficacy of dexmedetomidine vs fentanyl as an adjuvant to bupivacaine in thoracic epidural for midline laparotomies.
 
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