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

NCT ID: NCT03437213

Last Updated: 2020-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-09-01

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.

Conditions

Immune Suppression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Total intravenous anesthesia group

propofol, and fentanyl-based regimen.

Group Type: EXPERIMENTAL

Total intravenous anesthesia group

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

Total intravenous plus block group

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alaa Mazy Mazy

OTHER

Sponsor Role: lead

Responsible Party

Alaa Mazy Mazy

associate professor of anesthesia and surgical intensive care

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

MD/17.12.52

Identifier Type: -

Identifier Source: org_study_id