| CTRI Number |
CTRI/2020/01/022682 [Registered on: 10/01/2020] Trial Registered Prospectively |
| Last Modified On: |
23/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of different anesthetic techniques on inflammatory markers in patients undergoing major orthopedic trauma surgery |
|
Scientific Title of Study
|
Perioperative inflammatory cytokines alteration and neutrophil extracellular trap formation with various anesthetic techniques in patients undergoing major orthopedic trauma surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pallavi Tiwari |
| Designation |
PhD Research Scholar |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
C/O Dr. Babita Gupta,
Room no 124, first floor,
JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9971425687 |
| Fax |
|
| Email |
pallavitiwari18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Babita Gupta |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no 124, first floor,
JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9868397815 |
| Fax |
|
| Email |
drbabitagupta@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Tiwari |
| Designation |
PhD Research Scholar |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
C/O Dr. Babita Gupta,
Room no 124, first floor,
JPNATC, All India Institute of Medical Sciences (AIIMS), New Delhi-110029
All India Institute of Medical Sciences, Ansari Nagar, New Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9971425687 |
| Fax |
|
| Email |
pallavitiwari18@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences, New Delhi, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Pallavi Tiwari |
JPNATC, AIIMS, New Delhi |
JPNATC Operation theater,JPNATC Orthopedic ward, Department of Anaesthesiology, Pain Medicine & Critical Care, JPNATC, AIIMS, New Delhi-110029
New Delhi
DELHI |
9971425687
pallavitiwari18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
General and regional anesthesia |
Anesthetic Technique:
Patients will be assigned to different anesthetic technique by computer generated randomization.
Pre-anesthetic checkup will be done in all patients and visual analogue score (VAS) scoring will be explained to them. All patients will receive tablet alparazolam; night prior surgery as pre-medication.
Group A: General Anesthesia
Group A patients will receive balanced general anaesthesia comprising of fentanyl (2 mcg/kg) + propofol (2 mg/kg) followed by endotracheal intubation. Intra-operative maintenance will be with isoflurane + oxygen/nitrous oxide mixture and vecuronium (intermittent bolus). Depth of anaesthesia will be monitored with entropy and maintained between 50-60. Intra-operative analgesia will be maintained by IV morphine (0.1 mg/kg). Heart rate (HR) and blood pressure (BP) will be maintained between baseline +20%. Any hypotensive episode will be treated with IV fluids and ephedrine if required. Postoperative analgesia will be maintained with IV patient controlled analgesia (PCA) morphine 1 mg patient bolus with lockout interval half hour. If visual analogue scale (VAS) 4, morphine bolus will be increased to 2 mg. Patient-controlled analgesia (PCA) will be continued for 24 hours
Group B: Subarchnoid Block + Epidural Anesthesia
These patients will receive spinal + epidural anaesthesia. Subarachnoid block will be given; drug used will be 0.5 % bupivacaine (heavy) 2.5- 3 mL. Once the level recedes below T 10, test dose of 3 mL 2% lignocaine adrenaline (1:200,000) will be given through epidural catheter. If test dose is negative, epidural infusion at the rate 4-6 mL/hour of 0.25% bupivacaine with 2mcg/mL fentanyl solution will be started. Postoperative analgesia will be maintained by patient controlled epidural analgesia (PCEA) with baseline infusion of 0.0625% bupivacaine + 2 mcg/mL fentanyl at the rate 4-6 mL/hour + patient bolus 2 mL, with lockout interval half an hour which will be continued for 24 hours.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female arriving in OT for pelvic-acetabular injury and fracture shaft femur.
2. More than18- 60 years of age.
3. ASA Grade I/II patients i.e. with minimal risk of anesthesia as per standard practices.
|
|
| ExclusionCriteria |
| Details |
1. A Signs of infection present.
2. History of being operated within 3 months for any ailment.
3. Any allergy to anesthetic/ local anesthetic drugs.
4. Redo surgery.
5. Patient on immunosuppressant therapy.
6. History of inflammatory disorder.
7. Patients with difficult airway requiring fiber-optic intubation.
8. Contraindication to regional anesthesia i.e.platelet count < 80,000/cmm or PT INR > 1.5
9. Spine pathology present.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Influence of anesthetic technique on neutrophil extracellular trap & histone and stablish the diagnostic ability of NETs and Histone to early diagnosis of SIRS in major orthopedic trauma patients. |
5 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Quantification of NETs, histone and pro/anti-inflammatory cytokines at consecutive time points after major orthopedic surgery.
2. Optimal timing for nonlife-saving surgical interventions after trauma.
3. Damaged tissue healing and repair.
4. Second hit related MOF.
5. Hospital stay. |
5 years |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/01/2020 |
| 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="5"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The immuno-inflammatory response is initiated immediately after trauma & major surgery, which predisposes patients to multiple organ failure. Also postoperative pain is mainly caused by tissue inflammation. Cytokines are important mediator of local and systemic inflammatory response after surgery and studies suggest that the measurement of pro-inflammatory (TNF, IL6, IL1-β, IL8) and anti-inflammatory (IL10, sTNF-R1) cytokine concentration in plasma may help to quantify the systemic inflammatory response after surgery. General and regional anesthetic techniques provide efficient postoperative analgesia, because these techniques reduce stress response and cytokine activation after surgery. Anesthetic techniques also inhibit phagocytosis and bactericidal activity. Neutrophil extracellular traps (NETs), arise from a subset of neutrophils undergoing a new form of cell death, named NETosis, a newly identified immune mechanism and induced by inflammatory cytokines. Histone is a major component of NETs and also potently pro-inflammatory. Recently, it was observed that NETs were formed significantly in patients undergoing orthopedic surgeries. However, the sample size was very small and the authors included minor operative procedures also. The effect of anesthetic technique was also not discussed. There is sparse literature on anti-inflammatory effect of regional anesthesia in major surgeries. However, there are no clinical studies to date that evaluate effect of anesthesia technique in inflammatory markers, NETs and histone after trauma or major surgeries. We intend to see the influence of various anesthetic techniques on the neutrophil extracellular trap formation, pro-inflammatory and anti-inflammatory markers, so that the technique causing attenuation of inflammatory response or causing least inflammatory response can be recommended for better patient outcome. |