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Lumbar Disc HerniationPhase 2NCT04260685

Lidocaine Versus Esmolol for Optimizing Surgical Field Visibility

A Phase 2 study testing Lidocaine and Esmolol in people with Lumbar Disc Herniation, run by Zagazig University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Intra-operative blood loss is an important attribution and predictor of the lumbar spine surgery and patient outcome. Stripping the muscle off bone makes more exposed bleeding spine surface is one of causes for blood loss during lumbar surgeries. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Lidocaine and Esmolol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteEgypt
Study dates
4 Feb 2020to 30 Jun 2020
Phase
Phase 2
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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • American society of anesthesiologist( ASA): I\& II Physical status:
  • Body Mass Index( BMI)=(25-35 kg/m2).
  • Type of operations: lumbar discectomy.
  • Written informed consent from the patient.

Who cannot join

  • Patient refusal.
  • .Altered mental state
  • . Patients on beta-blockers or with a known history of allergy to study drugs.
  • Hepatic, renal, Cardiovascular and respiratory diseases.
  • Diabetic patients.
  • Patients receiving anticoagulants.
  • Previous spine surgery

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Faculty of Medicine

    Zagazig, Elsharkia, 022/055

Other trials in Egypt

About this study

Official title: Intraoperative Lidocaine Versus Esmolol Infusion for Optimizing Surgical Field Visibility During Lumbar Discectomy

Intra-operative blood loss is an important attribution and predictor of the lumbar spine surgery and patient outcome. Stripping the muscle off bone makes more exposed bleeding spine surface is one of causes for blood loss during lumbar surgeries. The importance to decrease the bleeding is to improve the surgical field visibility which provides technical ease for surgeon and decreases the surgical time besides maintaining the hemodynamic stability. In past, there were many trials to minimize surgical blood loss by different drugs such as Na Nitroprusside, magnesium sulfate, volatile anesthetics and beta-adrenergic antagonist.

Read the detailed description

Sample size:

Assuming mean and standard deviation of mean arterial pressure in lidocaine group versus esmolol group is 90±27.9 versus 73± 22.5 so the sample size will be 70 (35 in each group ) using Open Epi program with confidence level 95%, power of test 80% All patients will be hospitalized and visited a day before the surgery, full history with physical examination and routine investigation will be done, the nature and complications of the study will be explained in detail to the patient and informed written consent will be obtained from every participant.

All patients will be kept nil orally 6 hours before the operation. All surgeries will be done by the same surgeon to decrease observer's bias. The surgeon and the outcome assessor (anesthesiologist collect the data) will be blinded to study drugs.

Using computer generated randomization table, each group consists of 35 patients.

Being tested
Lidocaine, Esmolol
Keywords
esmolol, lidocaine, surgical field
Medical subject headings
Intervertebral Disc Displacement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LidocaineDrug

    Also called lignocaine

    IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h

  • EsmololDrug

    Also called Brevibloc

    IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min

Study groups in NCT04260685
Study groupRoleWhat they receive
lidocaineActive comparatorthe Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h
Receives: Drug: Lidocaine
esmololActive comparatorthe Patient will receive IV bolus of esmolol 0.5 mg/kg over ten minutes followed by continuous infusion of 100-300 ug/kg/min
Receives: Drug: Esmolol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The quality of surgical field visibility

    using the surgical field rating (SFR) scale of six points proposed by (Fromme et al 1986) :

    Grade 0: No bleeding - virtually bloodless field. Grade 1: Slight bleeding so no suctioning required. Grade 2: Slight bleeding so occasional suctioning required. Grade 3: Low bleeding- frequent suctioning required; bleeding threatens surgical field some seconds after suction is removed.

    Grade 4: Moderate bleeding- frequent suctioning required, bleeding threatens surgical field directly after suctioning.

    Grade 5: Sever bleeding so constant suctioning required; bleeding appears faster than can be removed by suction; surgical field severely threatened and surgery hardly possible.

    Measured: from the start of surgery till the end of surgery

  2. Mean arterial blood pressure

    automatically invasive measured every 3 minutes , recorded every 15 minutes till the end

    Measured: from induction of anesthesia till the end of surgery

Secondary outcomes (5)

  1. heart rate

    heart rate

    Measured: 15 minutes after the start of hypotensive agent

  2. simplified postoperative nausea and vomiting

    Postoperative nausea and vomiting impact scale score

    Measured: for the first 24 hours postoperative

  3. surgeon satisfaction

    Surgeon's satisfaction score

    1. Bad satisfaction.
    2. moderate satisfaction.
    3. Good satisfaction.
    4. excellent satisfaction

    Measured: "at completion of operation, an average 2 hours "

  4. The need for blood transfusion

    The number of patients need for blood transfusion: Acute blood loss more than 1,500 ml or 30% of blood volume is in need of blood transfusion

    Measured: "through study completion, an average of four months".

  5. the amount of blood loss

    Blood loss= Hb (gdL/1) X V (mL)/Hbm (g/dL); Intraoperative blood volume loss (V)=blood in the suction container with adjustment for the used irrigating saline and the blood soaked by gauze pieces [4×4 soaked gauze piece =15 ml blood, completely soaked abdominal towel =150 ml blood].Hb= Hb concentration of suction container and Hbm=patient's mean hemoglobin concentration at the start

    Measured: from the beginning of surgery till the end of surgery, an average two hours"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start4 Feb 2020
  3. Primary completion15 Jun 2020
  4. Study completion30 Jun 2020

Resources

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group L (lidocaine group) (n=35): the Patient will receive IV bolus of 1.5mg/kg lidocaine 1% over ten minutes followed by continuous infusion of 1.5mg/kg/h and will be terminated 10 minutes before the end of surgery. Group E(esmolol group) (n=35): the Patient will receive IV bolus of esmolol 0.5 mg/kg over ten minutes followed by continuous infusion of 100-300 ug/kg/min and will be terminated 10 minutes before the end of surgery.
Masking
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04260685
Sponsor's protocol ID
5901
Status last verified
Jun 2020
First submitted
21 Jan 2020
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lidocaine and Esmolol in people with Lumbar Disc Herniation, run by Zagazig University 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 7 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 2 Jul 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The quality of surgical field visibility (time frame: from the start of surgery till the end of surgery). 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?

On the ClinicalTrials.gov record for NCT04260685.

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 2 Jul 2020.

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