Effect of different anesthetic techniques on inflammatory markers in patients undergoing major orthopedic trauma surgery

Not yet recruiting

Conditions: Fracture of shaft of femur,

Registration Number: CTRI/2020/01/022682

Lead Sponsor: AIIMS

Brief Summary: The immuno-inï¬‚ammatory 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-Î², 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1): JPNATC, AIIMS, New Delhi
🇮🇳
Delhi, DELHI, India
JPNATC, AIIMS, New Delhi
🇮🇳Delhi, DELHI, India
Pallavi Tiwari
Principal investigator
9971425687
pallavitiwari18@gmail.com