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Posterior Fossa TumorPhase 3NCT03762343

Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy

A Phase 3 study testing ultrasound guided Greater occipital nerve block in people with Posterior Fossa Tumor, 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

Surgery within the posterior fossa is associated with the highest incidence and greatest severity of acute postoperative pain that may persist beyond the immediate postoperative period. Read more about this study

Who is it for?
Ages 2 to 10 years
Conditions the study is for
Posterior Fossa Tumor
What is being tested?
ultrasound guided Greater occipital nerve block
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Jan 2019to 1 Dec 2020
Phase
Phase 3
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 2 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • ASA physical status I or II,
  • Glasgow Coma Scale (GCS) 15,
  • children scheduled for craniotomy for posterior fossa tumors

Who cannot join

  • Refusal of patients guardians
  • Patients with suspected or proved allergic to local anesthetics
  • Emergency surgery,
  • Children with GCS < 15
  • Craniotomy incision beyond the coverage of the block will be excluded from the study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University

    Cairo

Other trials in Egypt

About this study

Official title: Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy: Randomized, Controlled Study

Surgery within the posterior fossa is associated with the highest incidence and greatest severity of acute postoperative pain that may persist beyond the immediate postoperative period.

The utilization of local nerve blocks of the scalp in children may provide analgesia with stable hemodynamics while reducing the need for other anesthetics such as inhaled anesthetics and opioids. This could in turn result in less side effects, higher patient and family satisfaction, and better outcomes.

The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain management of posterior fossa surgery in pediatrics is not previously reported.

Read the detailed description

Surgery within the posterior fossa is associated with the highest incidence and greatest severity of acute postoperative pain that may persist beyond the immediate postoperative period.

Despite a greater awareness of pain after all types of intracranial surgery, clinicians remain reluctant to administer opioids to patients undergoing intracranial surgery because the opioid side effects that may mask signs of neurologic decompensation.

Furthermore, opioids can depress minute ventilation, leading to hypercapnia and increased intracranial pressures. These concerns may be of greater relevance for surgery of the posteriorfossa. However, untreated, pain can also be detrimental. Patients in pain may appear agitated, uncooperative, and experience longer-term pain-related sequelae.

The utilization of local nerve blocks of the scalp in children may thus provide analgesia with stable hemodynamics while reducing the need for other anesthetics such as inhaled anesthetics and opioids: this could in turn result in less side effects, higher patient and family satisfaction, and better outcomes.

The use of ultrasound-guided greater occipital nerve block (GONB) for perioperative pain management of posterior fossa surgery in pediatrics is not previously reported.

The authors hypothesize that ultrasound-guided greater occipital nerve block (GONB) for perioperative pain management of posterior fossa is feasible and superior to conventional methods for perioperative pain management.

After institutional research ethics committee approval, 40 children aged (2-10 years), ASA physical status I or II, Glasgow Coma Scale (GCS) 15, scheduled for craniotomy for posterior fossa tumors will be recruited and a written informed consent will be obtained from the patient guardians.

Anesthetic management:

Patients will not receive any premedication. Upon arrival to the operating room heart rate, noninvasive blood pressure NBP and oxygen saturation SPO2 will be monitored using standard monitor (drȁger infinity vista XL) before inhalational induction of anesthesia using sevoflurane titration (2-8%). 20 or 22 G canula will be inserted after the patient is put to sleep. Anesthesia will be completed by fentanyl (2µg/kg) and atracurium 0.5mg/kg. if IV canula is present anesthesia will be induced by propofol (1-2 mg/kg), fentanyl (2µg/kg) and atracurium 0.5mg/kg After tracheal intubation anesthesia will be maintained using isoflurane 1% in oxygen and air (FIO2 0.6), atracurium infusion at a rate of 0.5 mg/kg/h. Controlled ventilation will be adjusted to maintain moderate hyperventilation (end tidal CO2 30-35 mmHg). A core temperature will be measured using nasopharyngeal probe and a Foley's catheter will be inserted in the urinary bladder. 22G radial arterial canula will be inserted for invasive blood pressure monitoring and blood sampling and central venous line (CVP) will be inserted under complete aseptic condition with ultrasound guidance and wide bore peripheral canula for fluid management.

Greater occipital nerve block:

After the patient is positioned in the prone position with mild neck flexion and after disinfection of the skin; the GON will be located in the short axis plane using the (M-Turbo TM) ultrasound system with a 6-13 MHz high-resolution linear ultrasound transducer (Sonosite, USA).

The ultrasound probe will be placed in a transverse plane over the classical block site, at the level of the superior nuchal line, with the center of the probe at about 2-3 cm lateral to the external occipital protuberance. The GON will be identified in the short axis plane, Then, under real-time scanning, A 22 G canula will be advanced guided with ultrasound using an in-plane (IP) technique from lateral to medial to position the tip of the canula exactly at the center of the nerve. Thereafter, 2 ml of bupivacaine 0.5% will be injected to block the nerve. This technique will then be repeated on the other side.

Vital signs (heart rate, arterial blood pressure, and SpO2) will be monitored continuously And recorded every 30 minutes intraoperatively, and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively. Bradycardia (heart rate less than 60 beats/minute) will be treated with atropine (0.02mg/kg IV). Fentanyl 0.5 µg /kg as rescue analgesia will be given if HR and systolic BP increased >20% of base line up to maximum 5 µg/ kg. 15 mg/kg of IV paracetamol will be given at the beginning of dural closure at the end of the procedure for both groups.

Postoperative assessment and analgesic regimen:

Objective Pain Scale (OPS) will be assessed at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively. The time to the first request of rescue postoperative analgesic will be: "the time interval between the onset of GONB and the first request to postoperative analgesia and or OPS score ˃2-3". When patients first complain of pain (OPS score ˃2-3) an intravenous paracetamol 15mg/kg will be given and will be repeated every 6 hours. Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.05mg/kg to maintain resting OPS at < 2-3. Cumulative 24 hours analgesic consumption will be recorded.

Being tested
ultrasound guided Greater occipital nerve block, control group C
Keywords
greater occipital nerve block, posterior fossa, ultrasound, pain, craniotomy
Medical subject headings
Infratentorial Neoplasms, Pain

What participants receive

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

  • ultrasound guided Greater occipital nerve blockDrug

    ultrasound guided Greater occipital nerve block with 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.

  • control group CDrug

    Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)

Study groups in NCT03762343
Study groupRoleWhat they receive
Greater occipital nerve block group (group GONB)ExperimentalPatient in this group will receive 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.
Receives: Drug: ultrasound guided Greater occipital nerve block
Control group (group C):Placebo comparatorPatient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
Receives: Drug: control group C

What is being measured

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

  1. Objective Pain Scale (OPS) at 12 hours postoperative.

    the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.

    total score = SUM of all points for all parameters

    • Minimum score: 0
    • Maximum score: 10
    • Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.

    Measured: at 12 hours postoperative

Secondary outcomes (6)
  1. Time to first request of postoperative rescue analgesics

    the time interval between the onset of GONB and the first request to postoperative analgesia and or OPS score ˃2- 3".

    Measured: within 24 hours

  2. Objective Pain Scale (OPS) up to 24 hours.

    the score has five items(systolic blood pressure, crying, movement,agitation and complain of pain) with a minimum of zero and a maximum of 2 for each item.

    total score = SUM of all points for all parameters

    • Minimum score: 0
    • Maximum score: 10
    • Maximum score if too young to complain of pain: 8 if the score is used with 5 items, a score exceeding the number 3 requires therapeutically effective analgesic. if the score is used with its 4 items, a score exceeding the number 2 requires therapeutic effective analgesic.

    Measured: at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively

  3. Perioperative hemodynamic parameters

    Heart rate

    Measured: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively

  4. side effects

    number of patients who develop scalp hematoma in the GONB group

    Measured: within 24 hours

  5. side effects

    number of patients who develop postoperative nausea and vomiting

    Measured: within 24 hours

  6. Perioperative hemodynamic parameters

    systolic and diastolic arterial blood pressure.

    Measured: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively

Timeline

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

  1. First posted3 Dec 2018
  2. Study start1 Jan 2019
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03762343
Sponsor's protocol ID
N-11/s /2015/MD
Status last verified
Aug 2022
First submitted
28 Nov 2018
Last updated
15 Aug 2022
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 3 study testing ultrasound guided Greater occipital nerve block in people with Posterior Fossa Tumor, 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 3 inclusion and 5 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 15 Aug 2022. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Objective Pain Scale (OPS) at 12 hours postoperative. (time frame: at 12 hours postoperative). 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 15 Aug 2022.

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