Clinical trial NCT03437213: The Immune Modulation of Bilateral Paravertebral Block and Propofol in Spine Surgery.
Official title: The Immunomodulatory Effect of Bilateral Paravertebral Block and Total Intravenous Anesthesia in Spine Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Suppression
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Spine surgery is characterized by an elevation in levels of the inflammatory cytokines such as interleukin IL-6, IL-1β, and IL-17. These cytokines promote chemokine production and changes in cell phenotype which lead to activation of T and B cells, macrophages, neutrophils, and mast cells further amplifying the inflammatory cascade. Different analgesic modalities are used for pain management during and after spine surgery as narcotic analgesics, nonsteroidal anti-inflammatory drugs, Paracetamol and neuraxial techniques like intrathecal drug administration, epidural analgesia and paravertebral block. In this study, Paravertebral Block is used as a new and recent analgesic strategy for spine surgery. It has the advantage of higher success rate and analgesic efficacy, less risk of neurological complications than most other regional anesthetic techniques, less nausea, vomiting, and constipation compared with opioid-based analgesic techniques, urinary retention does not occur, unlike neuraxial techniques and intense block of both the sympathetic and somatic nerves. This study will be conducted with the hypothesis that the addition of paravertebral block as an analgesic regimen with total intravenous anesthesia (propofol-based) will have a better Immunomodulatory effect in patients undergoing posterior lumbar spine fixation surgery.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Serum levels of interleukin 6 (IL-6).
timeFrame: 24 hours postoperative
measure: Serum levels of interleukin 1β (IL-1β).
timeFrame: 24 hours postoperative.
Secondary outcomes:
measure: Total leukocyte count.
timeFrame: 24 hours postoperative.
measure: Absolute neutrophil count.
timeFrame: 24 hours postoperative.
measure: Neutrophil-Lymphocyte-Ratio (N/L ratio).
timeFrame: 24 hours postoperative.
measure: Serum cortisol level.
timeFrame: 24 hours postoperative.
measure: C-reactive protein serum level.
timeFrame: Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.
measure: the time to the first analgesic request.
timeFrame: 24 hours postoperative.
measure: Total morphine consumption.
timeFrame: 24 hours postoperative.
measure: The total amount of blood loss.
timeFrame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
measure: The amount of allogenic blood transfusion.
timeFrame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
measure: the duration of surgery.
timeFrame: intraoperative.
measure: The length of hospital stay.
timeFrame: 1-5 days postoperative.
measure: Mean arterial pressure
timeFrame: Basal 30 minutes preoperative, 5 minutes after intubation, 5 minutes after prone position, after 30, 60, 90, 120, 150, 180 min intraoperative. Postoperative, at 6, 12, 24 h after operation.
measure: Heart rate
timeFrame: Basal 30 minutes preoperative, 5 minutes after intubation, 5 minutes after prone position, after 30, 60, 90, 120, 150, 180 min intraoperative. Postoperative, at 6, 12, 24 h after operation.
measure: Numeric Pain Scale
timeFrame: 24 hours postoperative.
measure: The European Quality of Life-5 Dimensions measures.
timeFrame: After 1st, 2nd, 3rd months postoperative.
measure: Basal Metabolic Rate
timeFrame: After 1st, 2nd, 3rd months postoperative.
measure: The rate of postoperative complications
timeFrame: Postoperative within 72 hours after surgery.
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University Hospital
state: Dakahlia
Study officials:
References: