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Scoliosis IdiopathicPhase 2NCT03968146

Erector Spinae Plane Block in Scoliotic Adolescents

A Phase 2 study testing Erector Spinae Plane Block, Fentanyl and additional Fentanyl in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Kasr El Aini Hospital 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

For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay. Read more about this study

Who is it for?
Ages 8 to 18 years
What is being tested?
Erector Spinae Plane Block, Fentanyl and additional Fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteEgypt
Study dates
18 Jun 2019to 2 Dec 2019
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 8 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • American society of Anesthesia classification (ASA) I-II
  • Patients undergoing dorsal spine instrumentation for scoliosis.

Who cannot join

  • Refusal of block.
  • Bleeding tendency with prothrombin concentration PC less than 75 % or platelet count less than 150,000/µL.
  • Skin lesion, wounds or infection at the puncture site.
  • Known allergy to local anaesthetic drugs.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University Hospitals

    Cairo

Other trials in Egypt

About this study

Official title: Ultrasound Guided Erector Spinae Plane Block in Scoliotic Adolescents Undergoing Posterior Spine Instrumentation . A Randomized Controlled Trial

For scoliotic surgeries, Erector Spinae Plane Block (ESPB) can add to the multimodal approach for perioperative pain management with decreasing the opioids requirement, improving recovery and decreasing ICU stay.

Read the detailed description

All patients will be assessed clinically and investigated for Pulmonary function test and Echocardiography. Laboratory work needed will be: Complete blood count (CBC); prothrombin time and concentration (PT\& PC); partial thromboplastin time (PTT); bleeding time (BT); clotting time (CT) and liver function tests.

an online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the two study groups. Random allocation numbers will be concealed in opaque closed envelops.participants and those assessing/analyzing the outcome(s) will be blind to group assignment.

Eutectic Mixture of Local Anesthetics (EMLA) cream will be applied to the site of venous puncture. After insertion of venous access, all children will receive midazolam at a dose of 0.1 mg/Kg. Intraoperative monitoring will include continuous electrocardiogram (ECG), pulse oximetry, invasive arterial blood pressure, end-tidal carbon dioxide (CO2), inhaled gas analyzer and temperature monitoring.

General anesthesia will be induced in both groups (Erector Spinae group and control group) using propofol 2.5 mg/kg over 20-30 seconds, atracurium 0.5 mg/kg to facilitate endotracheal intubation and fentanyl 1 µg/kg. Anesthesia will be maintained using isoflurane (1 MAC) and atracurium infused as 0.5 mg/kg/hr. All patients will receive IV ranitidine 2 mg/kg, ondansetron 0.1 mg/kg, cefotaxime 50 mg/kg and acetaminophen 15 mg/kg. An arterial catheter and a urinary catheter will be placed. Then patients will be turned to the prone position.

In group E: will receive Erector Spinae Plane Block (ESPB) In group C: control group will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision. After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

In both groups, if the analgesia obtained from both methods of ESBP or IV fentanyl was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg). Total blood loss, duration of surgery, number of vertebral levels fixed, total fentanyl consumed will be recorded. After completion of surgical procedure and emergence from anesthesia the patient will be referred to post-anaesthesia care unit (PACU). Quality of analgesia will be assessed immediately postoperative and then at 4, 8, 12, 16, and 24 hours postoperatively in the Intensive Care Unit (ICU) by using VAS pain score. All patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours, ketorolac from second day 15 mg q 6 hours, not to exceed 5 days. Patients will also receive ranitidine 2 mg/kg q 12 hours. Vital signs and urinary output will be monitored. Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if visual analogue scale (VAS) pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr. After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg. Morphine will be stopped if maximum hourly dose is reached or the patient becomes sedated (Ramsay score >2), has a ventilatory rate of <12 bpm, or an oxygen saturation of <95%, or has a serious adverse event (allergy, hypotension, severe vomiting).

Patients will be continuously monitored in the PACU and ICU. Naloxone and full resuscitation equipment are available. Time of first need for morphine and total 24 hr morphine consumption will be recorded. Complications e.g nausea, vomiting, pruritis or respiratory depression will be recorded.

Being tested
Erector Spinae Plane Block, Fentanyl, additional Fentanyl, Morphine, rescue Morphine
Medical subject headings
Scoliosis

What participants receive

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

  • Erector Spinae Plane BlockProcedure or surgery

    The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.

  • FentanylDrug

    Also called fentanyl for induction and maintenance

    patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).

  • additional FentanylDrug

    patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.

  • MorphineDrug

    Also called morphine infusion

    After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.

  • rescue MorphineDrug

    Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.

  • pethidineDrug

    After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.

  • KetorolacDrug

    patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.

  • AcetaminophenDrug

    patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours

Study groups in NCT03968146
Study groupRoleWhat they receive
Group EActive comparatorpatients will receive Erector Spinae plane block in addition to intravenous fentanyl
Receives: Procedure: Erector Spinae Plane Block; Drug: Fentanyl; Drug: rescue Morphine; Drug: pethidine; Drug: Ketorolac; Drug: Acetaminophen
Group COtherControl group will receive only intravenous fentanyl.
Receives: Drug: Fentanyl; Drug: additional Fentanyl; Drug: Morphine; Drug: rescue Morphine; Drug: pethidine; Drug: Ketorolac; Drug: Acetaminophen

What is being measured

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

  1. Total morphine consumption

    Total postoperative rescue morphine consumption in mg/kg for each group in the first 24 hours post-operative period.

    Measured: the first 24 hours post-operative period.

Secondary outcomes (2)
  1. Total fentanyl consumption

    Total intraoperative fentanyl consumption in mcg/kg for each group.

    Measured: intraoperative period

  2. Visual Analogue Scale

    the visual analogue scale (VAS) is for Pain assessment It is a * total 10 cm * linear scale for pain it ranges from minimum ( 0 for no pain at all ) to maximum ( 10 for the worst pain imaginable ) higher number values indicate worst outcome. For example, as the patient mark the scale nearer to maximum, this indicate more severe pain.

    Measured: the first 24 hours post-operative period.

Timeline

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

  1. First posted30 May 2019
  2. Study start18 Jun 2019
  3. Primary completion5 Nov 2019
  4. Study completion2 Dec 2019

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03968146
Sponsor's protocol ID
N-15-2019
Status last verified
Dec 2019
First submitted
27 May 2019
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Erector Spinae Plane Block, Fentanyl and additional Fentanyl in people with Scoliosis Idiopathic and Scoliosis; Adolescence, run by Kasr El Aini Hospital 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 2 inclusion and 4 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 3 Dec 2019. 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?

Total morphine consumption (time frame: the first 24 hours post-operative period.). 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 3 Dec 2019.

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