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The Immune Modulation of Bilateral Paravertebral Block and Propofol in Spine Surgery.

NCT03437213 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-18

No results posted yet for this study

Summary

General anesthesia has an important effect on inflammatory cytokines. Inhalational agents as isoflurane and sevoflurane attenuate immune function expressed by neutrophil chemoattractant-1 as well as inflammatory enzyme and also they reduce inflammatory cascade. Total intravenous anesthesia (TIVA) based on using propofol suppresses the inflammatory response caused by surgery to a greater extent because Propofol affects the balance between pro-inflammatory and anti-inflammatory cytokines, increasing production of the anti-inflammatory cytokine IL-10 and at the same time reducing the increase of IL-6 during the perioperative period. It also alters expression of nitric oxide and inhibits neutrophil function. TIVA has many advantages such as; fewer side effects, earlier discharge, better patient satisfaction, faster recovery, less nausea and vomiting and reduced muscle relaxant requirements. Paravertebral block has an important role in the inflammatory and immune response. The paravertebral block can decrease perioperative inflammation and prevent immune suppression. Also, it can attenuate the cytokine response and reduce acute stress response caused by surgery. Decrease inflammation processes, improve surgery result, limit the duration of hospital stay, decrease post-operative fatigue and reduce postoperative complications.

Conditions

  • Immune Suppression

Interventions

DRUG

Total intravenous anesthesia group

Induction of general anesthesia with fentanyl, (1mcg / kg), propofol (1-2 mg / kg), atracurium (0.5 mg / kg), intubation. Anesthesia maintained using Propofol (4-6) mg/kg/h, fentanyl (0.5-1) μg/kg/h. to be modified according to analgesic needs and hemodynamics. 10mg atracurium when the 2nd twitch of train of four appears.

DRUG

Total intravenous plus block group

Ultrasound guidance identifies the paravertebral space using a linear high-frequency (10-12 MHz) probe in the transverse plane in the midline, rotate the probe to the longitudinal plane, and scan in a medial-to-lateral direction. Locate the desired segment shift from the cephalad aspect of the sacrum. The transverse scan will show a hyperechoic outline of the vertebral spinous and transverse processes. Use the loss of resistance technique. Bilaterally inject (5ml) bupivacaine 0.5% for each segment. Induction of anesthesia after 30 minutes with fentanyl, (1mcg / kg), propofol (1-2 mg / kg), atracurium (0.5 mg / kg),then prone position.

Sponsors & Collaborators

  • Alaa Mazy Mazy

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2019-08-25
Completion
2020-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03437213 on ClinicalTrials.gov