ClinicalTrials.gg
CompletedNCT03762343Updated Aug 15, 2022

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

A Phase 3 interventional study of ultrasound guided Greater occipital nerve block and control group C in Posterior Fossa Tumor, sponsored by Kasr El Aini Hospital. Completed at 1 site in Egypt. Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-08-15.

Sponsored by Kasr El Aini Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
2 Years to 10 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Posterior Fossa Tumor

Keywords

  • greater occipital nerve block
  • posterior fossa
  • ultrasound
  • pain
  • craniotomy
03

In context

Infratentorial Neoplasms

21 studies on the registry are indexed under Infratentorial Neoplasms; 5 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 11 interventional studies indexed under Infratentorial Neoplasms.

Browse Infratentorial Neoplasms studies →

Lead sponsor

Kasr El Aini Hospital is the lead sponsor of 283 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Greater occipital nerve block group (group GONB)

    Patient 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.

    Drug: ultrasound guided Greater occipital nerve block

  • Placebo comparator
    Control group (group C):

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

    Drug: control group C

Interventions

  • Drugultrasound guided Greater occipital nerve block

    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.

  • Drugcontrol group C

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

06

What researchers measure

Primary outcomes

  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.

    Time frame: at 12 hours postoperative

Secondary outcomes

  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".

    Time frame: 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.

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

  3. Perioperative hemodynamic parameters

    Heart rate

    Time frame: 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

    Time frame: within 24 hours

  5. side effects

    number of patients who develop postoperative nausea and vomiting

    Time frame: within 24 hours

  6. Perioperative hemodynamic parameters

    systolic and diastolic arterial blood pressure.

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

07

Study locations

1 site
  • Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2019 to primary completion in Dec 2020, 23 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2018
First posted
Dec 3, 2018
StartActual
Jan 1, 2019
Primary completionActual
Dec 1, 2020
CompletionActual
Dec 1, 2020
Last update
Aug 15, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03762343
Responsible party
Khaled Abdelfattah Abdallah Sarhan (lecturer of anesthesia, SICU and pain management, Kasr El Aini Hospital) — Principal investigator
First posted
Dec 3, 2018
Start date
Jan 1, 2019
Primary completion
Dec 1, 2020
Completion
Dec 1, 2020
Last update
Aug 15, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion