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Completed

NCT Number: NCT03437213

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

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.

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Key information

Conditions

Immune Suppression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: 24 hours postoperative

    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.

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

    Time frame: 24 hours postoperative.

    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.

Secondary outcomes

  1. Total leukocyte count.

    Time frame: 24 hours postoperative.

    Number multiplied by 1000 /micro liter, measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

  2. Absolute neutrophil count.

    Time frame: 24 hours postoperative.

    Number multiplied by 1000 /micro liter, measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

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

    Time frame: 24 hours postoperative.

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

  4. Serum cortisol level.

    Time frame: 24 hours postoperative.

    Micro-gram per deciliter by immunoassays techniques. Measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.

  5. C-reactive protein serum level.

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

    milligram per liter using ELISA techniques.

  6. the time to the first analgesic request.

    Time frame: 24 hours postoperative.

    hours.

  7. Total morphine consumption.

    Time frame: 24 hours postoperative.

    milligram.

  8. The total amount of blood loss.

    Time frame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).

    milliliter, estimated by weighing the swabs and blood suction loss.

  9. The amount of allogenic blood transfusion.

    Time frame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).

    Unites.

  10. the duration of surgery.

    Time frame: intraoperative.

    Minutes, from the start of anesthesia to the extubation time.

  11. The length of hospital stay.

    Time frame: 1-5 days postoperative.

    Days, Starts from 0 hour postoperative time until patient discharge from the hospital.

  12. Mean arterial pressure

    Time frame: 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.

    millimeter mercury

  13. Heart rate

    Time frame: 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.

    Beats per minute.

  14. Numeric Pain Scale

    Time frame: 24 hours postoperative.

    A scale from 0 to 10, where 0= no pain, and 10= worst imaginable pain. The patient describe subjective pain feeling in a number from (0- 10). Measured basal 30 minutes before anesthesia, 30 min after para-vertebral block. postoperative at 6, 12, 24 hours. then after 1st, 2nd, 3rd months postoperative.

  15. The European Quality of Life-5 Dimensions measures.

    Time frame: After 1st, 2nd, 3rd months postoperative.

    The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: 1, no problems, 2, slight problems, 3, moderate problems, 4, severe problems, and 5, extreme problems. by ticking a box. the final result is a 5 number code that represents the health state.

  16. Basal Metabolic Rate

    Time frame: After 1st, 2nd, 3rd months postoperative.

    Calories. by the Mifflin - St Jeor equation equals = 10 × weight (kg) + 6.25 × height (cm) - 5 × age(y) + 5

  17. The rate of postoperative complications

    Time frame: Postoperative within 72 hours after surgery.

    the percent of the complications: thromboembolic events, surgical complications (Wound infection, bleeding, wound hematoma and neurological complication), postoperative fever, and nausea with vomiting.

Sponsors and collaborators

Lead sponsor

Alaa Mazy Mazy

Other

Registry information

Official study title

The Immunomodulatory Effect of Bilateral Paravertebral Block and Total Intravenous Anesthesia in Spine Surgery.

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 19, 2018
Registry last updated
Sep 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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