| 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
|
|
|
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
|
|
|
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. |