FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069438 [Registered on: 25/06/2024] Trial Registered Prospectively
Last Modified On: 24/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of combination of two classes of adjuvants on duration of analgesia and visual analogue scores for postoperative analgesia in proximal femoral nailing surgeries  
Scientific Title of Study   Ultrasound guided suprainguinal fascia iliaca compartment block for proximal femoral nailing surgeries under spinal anaesthesia Comparison of efficacy of combination of dexamethasone and dexmedetomidine as adjuvants versus dexamethasone alone with ropivacaine  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K Sree lekha 
Designation  Post graduate 
Affiliation  Government Medical College Kadapa  
Address  Department of Anaesthesiology Government Medical College Government General Hospital Putlampalli Kadapa

Cuddapah
ANDHRA PRADESH
516002
India 
Phone  08498855791  
Fax    
Email  sreelekhakanipakam120@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Vijaya Durga 
Designation  Assistant Professor 
Affiliation  Government Medical College Kadapa  
Address  Department of anaesthesiology Government medical college Government general hospital Putlampalli Kadapa
Government medical college
Cuddapah
ANDHRA PRADESH
516002
India 
Phone  9177923023  
Fax    
Email  s.durga.dr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  K Sree lekha 
Designation  Post graduate 
Affiliation  Government Medical College Kadapa  
Address  Department of anaesthesiology Government Medical College Putlampalli Kadapa
Government medical college
Cuddapah
ANDHRA PRADESH
516002
India 
Phone  08498855791  
Fax    
Email  sreelekhakanipakam120@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Government medical college Kadapa 516002 Andhra Pradesh India  
 
Primary Sponsor  
Name  Dr K Sreelekha 
Address  Department of anaesthesiology Government medical college Government general hospital Putlampalli Kadapa 
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 K Sreelekha  Government general hospital  Department of anaesthesiology Government medical college Government general hospital Putlampalli Kadapa
Cuddapah
ANDHRA PRADESH 
08498855791

sreelekhakanipakam120@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Government medical college (RIMS) Kadapa  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S720||Fracture of head and neck of femur, (2) ICD-10 Condition: S720||Fracture of head and neck of femur, (3) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A  will receive FICB with 28 mL of levobupivacaine 0.25% plus with 2 ml normal saline (NS) (total volume 30 mL). 
Comparator Agent  Group B  will receive FICB with 28 mL of levobupivacaine 0.25% plus 4 mg dexamethasone (1ml) plus 1 ml normal saline (total volume 30 mL). 
Comparator Agent  Group c  will receive FICB with 28 mL of levobupivacaine 0.25% plus 50 μg dexmedetomidine (0.5mL) plus 1.5 mL normal saline (total volume 30 mL). 
Comparator Agent  Group D  will receive FICB with 28 mL of levobupivacaine 0.25% plus 4 mg dexamethasone (1ml) plus 50 μg dexmedetomidine (0.5mL) plus 0.5 mL normal saline (total volume 30 mL). 
Intervention  Suprainguinal fascia iliaca compartment block  Ultrasound guided suprainguinal fascia iliaca compartment block immediately after spinal anaesthesia Patient then Monitored for 24hours postoperatively 
 
Inclusion Criteria  
Age From  24.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists (ASA) physical status I or II, who were scheduled for proximal femoral nailing (PFN) surgery (for Inter-trochanteric fracture femur) by surgeons with identical surgical expertise, under subarachnoid block were registered in this trail. 
 
ExclusionCriteria 
Details  patients with coagulation abnormalities, cerebrovascular diseases, cognitive impairment, poly-trauma, hepatic and renal failure,subjects having local site infection or altered anatomy like inguinal hernia, allergy to study drugs, and pregnancy were excluded from the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of postoperative analgesia  First 24 hours of postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of block
Haemodynamic variations
Level of sedation
Adverse effects 
First 24 hours of postoperative period 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3/ Phase 4 
Date of First Enrollment (India)   05/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/07/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
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  
Ultrasound‑guided fascia iliaca compartment block (FICB), commonly practicing regional technique in proximal femur surgery, for providing effective postoperative analgesia with comparatively less adverse effects. FICB is a procedure that acts by blocking several nerves namely femoral nerve, lateral femoral cutaneous nerve, and obturator nerve. However, single injection technique of FICB is effective for postoperative pain management, it is often inadequate, as postoperative pain can persist for many days.
Many studies demonstrated the effectiveness of various local anaesthetic drugs in FICB. Local anaesthetic drugs like bupivacaine, levobupivacaine, and ropivacaine are the commonly using agents. At low concentrations these local anaesthetic agents produces only sensory block without affecting motor function. Various additives such as opioids, dexamethasone, α-adrenergic agonists (clonidine, dexmedetomidine) are routinely combined with local anaesthetic drugs to magnify the duration of analgesia and shortens the onset of block. Combining two additive agents can improve patient control and enable the use of lower doses of each individual agent without causing unfavourable side effects.
Levobupivacaine is an S-enantiomer of bupivacaine that appears to exhibit less cardiovascular toxicity than bupivacaine. It also has a better efficacy and safety profile. Dexamethasone is a long-acting glucocorticosteroid, numerous studies have shown that, it was highly efficient when used as an adjuvant to local anaesthetics. Short-term use (> 24 h) of single dose of dexamethasone is observed to be safe with infrequent adverse effects. Many researches used dexamethasone in a dose of 8 mg to increase the duration of analgesia. However, some investigations have used less than 8 mg dose of dexamethasone and concluded acceptable outcome. Dexmedetomidine is an α2 agonist, when added to local anaesthetics in peripheral nerve blocks, it improves the quality of anaesthesia as well as increases postoperative analgesia.
The mechanism of dexamethasone and dexmedetomidine in improving the duration of local anaesthetics action are not clearly explained. Both dexamethasone and dexmedetomidine can effectively decreases local inflammation and extend the duration of block through vasoconstriction by conserving the local concentration of the local anesthetic. Vasoconstriction also supress the nociceptive impulse transmission along myelinated C fibers. In peripheral nerve blockade dexmedetomidine appears to involve in suppression of hyperpolarization-activated cation current, thereby preventing the nerve from reverting to its resting membrane potential. Additionally, some investigations reveals that dexmedetomidine may operate as a
local anaesthetic by inhibiting the conduction of nerve signals through C and Aδ fibres rather than through α2 action.
In view of their distinct modes of action, we postulated that levobupivacaine in combination with dexamethasone and dexmedetomidine may further extend he duration of peripheral nerve blocks. Therefore, we conducted this prospective, randomized trial to investigate whether the addition of two adjuvants (dexmedetomidine and dexamethasone) to levobupivacaine for FICB improves the duration of postoperative analgesia, as compared with each adjuvant alone with levobupivacaine. We also examined the quality of block, haemodynamic variations, level of sedation and adverse effects across the groups as secondary outcomes.
 
Close