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

NCT03437213 | Completed

• 1 other identifier: MD/17.12.52
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Serum levels of interleukin 6 (IL-6).

  picogram/milliliter using ELISA techniques. Measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

  24 hours postoperative

• Serum levels of interleukin 1β (IL-1β).

  picogram/milliliter using ELISA techniques. Measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

  24 hours postoperative.

Secondary Outcomes (17)

• Total leukocyte count.

  24 hours postoperative.

• Absolute neutrophil count.

  24 hours postoperative.

• Neutrophil-Lymphocyte-Ratio (N/L ratio).

  24 hours postoperative.

• Serum cortisol level.

  24 hours postoperative.

• C-reactive protein serum level.

  Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

Study Arms (2)

Total intravenous anesthesia group

EXPERIMENTAL

propofol, and fentanyl-based regimen.

Drug: Total intravenous anesthesia group

Total intravenous plus block group

ACTIVE COMPARATOR

ultrasound guided paravertebral block before induction then propofol and fentanyl maintenance.

Drug: Total intravenous plus block group

Interventions

Total intravenous anesthesia group DRUG

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.

Total intravenous anesthesia group

Total intravenous plus block group DRUG

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.

Total intravenous plus block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled for primary fixation of posterior lumbar spine surgery.
• American Society of Anesthesia statuses I or II patients.
• Single or double level lumbar spine fixation.
• Fixed surgical team.

You may not qualify if:

• Patient refusal or uncooperative Patient.
• History of allergy to any anesthetic agents will be used in the study.
• Local sepsis.
• Abnormal coagulation test results.
• Usage of antiplatelet therapy.
• Demyelinated neurological diseases as multiple sclerosis.
• Mental retardation, psychotropic drug consumption.
• Recurrent spine fixation.
• Severe coronary or peripheral artery disease.
• Severe cardiac disease, renal or hepatic failure.

Sponsors & Collaborators

• Alaa Mazy Mazy: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor of anesthesia and surgical intensive care

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: January 1, 2018
• Primary Completion: August 25, 2019
• Study Completion: September 1, 2020
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

EG (1)