Immune SuppressionNCT03437213
The Immune Modulation of Bilateral Paravertebral Block and Propofol in Spine Surgery.
A study testing Total intravenous anesthesia group and Total intravenous plus block group in people with Immune Suppression, run by Alaa Mazy Mazy at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immune Suppression
- What is being tested?
- Total intravenous anesthesia group and Total intravenous plus block group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Mental retardation, psychotropic drug consumption.
- Recurrent spine fixation.
- Severe coronary or peripheral artery disease.
- Severe cardiac disease, renal or hepatic failure.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: The Immunomodulatory Effect of Bilateral Paravertebral Block and Total Intravenous Anesthesia 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.
Read the 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
- Being tested
- Total intravenous anesthesia group, Total intravenous plus block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total intravenous anesthesia groupDrug
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 groupDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia group | Experimental | propofol, and fentanyl-based regimen. Receives: Drug: Total intravenous anesthesia group |
| Total intravenous plus block group | Active comparator | ultrasound guided paravertebral block before induction then propofol and fentanyl maintenance. Receives: Drug: Total intravenous plus block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 hours postoperative.
Secondary outcomes (17)
Total leukocyte count.
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.
Measured: 24 hours postoperative.
Absolute neutrophil count.
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.
Measured: 24 hours postoperative.
Neutrophil-Lymphocyte-Ratio (N/L ratio).
ratio. Measured Basal: 30 minutes before starting anesthesia, 2 hours after starting surgery, 8 and 24 hours from the end of surgery postoperative.
Measured: 24 hours postoperative.
Serum cortisol level.
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.
Measured: 24 hours postoperative.
C-reactive protein serum level.
milligram per liter 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.
the time to the first analgesic request.
hours.
Measured: 24 hours postoperative.
Total morphine consumption.
milligram.
Measured: 24 hours postoperative.
The total amount of blood loss.
milliliter, estimated by weighing the swabs and blood suction loss.
Measured: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
The amount of allogenic blood transfusion.
Unites.
Measured: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
the duration of surgery.
Minutes, from the start of anesthesia to the extubation time.
Measured: intraoperative.
The length of hospital stay.
Days, Starts from 0 hour postoperative time until patient discharge from the hospital.
Measured: 1-5 days postoperative.
Mean arterial pressure
millimeter mercury
Measured: 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.
Heart rate
Beats per minute.
Measured: 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.
Numeric Pain Scale
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.
Measured: 24 hours postoperative.
The European Quality of Life-5 Dimensions measures.
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.
Measured: After 1st, 2nd, 3rd months postoperative.
Basal Metabolic Rate
Calories. by the Mifflin - St Jeor equation equals = 10 × weight (kg) + 6.25 × height (cm) - 5 × age(y) + 5
Measured: After 1st, 2nd, 3rd months postoperative.
The rate of postoperative complications
the percent of the complications: thromboembolic events, surgical complications (Wound infection, bleeding, wound hematoma and neurological complication), postoperative fever, and nausea with vomiting.
Measured: Postoperative within 72 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jan 2018
- Primary completion25 Aug 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alaa Mazy Mazy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alaa Mazy Mazy, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437213
- Sponsor's protocol ID
- MD/17.12.52
- Status last verified
- Sep 2020
- First submitted
- 5 Feb 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunomodulatory Effect of Bilateral Paravertebral Block and Total Intravenous Anesthesia in Spine Surgery.
- ClinicalTrials.gov ID
- NCT03437213
- Acronym / sponsor ID
- MD/17.12.52
- Conditions
- Immune Suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alaa Mazy MazyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia group | Experimental | Drug: Total intravenous anesthesia grouppropofol, and fentanyl-based regimen. |
| Total intravenous plus block group | Active comparator | Drug: Total intravenous plus block groupultrasound guided paravertebral block before induction then propofol and fentanyl maintenance. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total intravenous anesthesia groupInduction 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 anesthesia group |
| Total intravenous plus block groupUltrasound 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. | Drug | Total intravenous plus block group |
Primary outcome
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.
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.
17 secondary outcomes
Total leukocyte count.
Time frame: 24 hours postoperative.
Absolute neutrophil count.
Time frame: 24 hours postoperative.
Neutrophil-Lymphocyte-Ratio (N/L ratio).
Time frame: 24 hours postoperative.
Serum cortisol level.
Time frame: 24 hours postoperative.
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.
the time to the first analgesic request.
Time frame: 24 hours postoperative.
Total morphine consumption.
Time frame: 24 hours postoperative.
The total amount of blood loss.
Time frame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
The amount of allogenic blood transfusion.
Time frame: Intraoperative; from the start of anesthesia to the end of surgery (minutes).
the duration of surgery.
Time frame: intraoperative.
The length of hospital stay.
Time frame: 1-5 days postoperative.
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.
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.
Numeric Pain Scale
Time frame: 24 hours postoperative.
The European Quality of Life-5 Dimensions measures.
Time frame: After 1st, 2nd, 3rd months postoperative.
Basal Metabolic Rate
Time frame: After 1st, 2nd, 3rd months postoperative.
The rate of postoperative complications
Time frame: Postoperative within 72 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total intravenous anesthesia group and Total intravenous plus block group in people with Immune Suppression, run by Alaa Mazy Mazy at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of interleukin 6 (IL-6). (time frame: 24 hours postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2020.