Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy
Primary Purpose
Posterior Fossa Tumor
Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided Greater occipital nerve block
control group C
Sponsored by
About this trial
This is an interventional treatment trial for Posterior Fossa Tumor focused on measuring greater occipital nerve block, posterior fossa, ultrasound, pain, craniotomy
Eligibility Criteria
Inclusion Criteria:
- ASA physical status I or II,
- Glasgow Coma Scale (GCS) 15,
- children scheduled for craniotomy for posterior fossa tumors
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.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Greater occipital nerve block group (group GONB)
Control group (group C):
Arm Description
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.
Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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".
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.
Perioperative hemodynamic parameters
Heart rate
side effects
number of patients who develop scalp hematoma in the GONB group
side effects
number of patients who develop postoperative nausea and vomiting
Perioperative hemodynamic parameters
systolic and diastolic arterial blood pressure.
Full Information
NCT ID
NCT03762343
First Posted
November 28, 2018
Last Updated
August 11, 2022
Sponsor
Kasr El Aini Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03762343
Brief Title
Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy
Official Title
Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy: Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Fossa Tumor
Keywords
greater occipital nerve block, posterior fossa, ultrasound, pain, craniotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation. The intraoperative study outcomes will be assessed by an anesthetist who is not involved in the block performance and postoperative data will be collected by PICU trained nurses who are blinded to the study groups.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Greater occipital nerve block group (group GONB)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group (group C):
Arm Type
Placebo Comparator
Arm Description
Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
Intervention Type
Drug
Intervention Name(s)
ultrasound guided Greater occipital nerve block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
control group C
Intervention Description
Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
Primary Outcome Measure Information:
Title
Objective Pain Scale (OPS) at 12 hours postoperative.
Description
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 Outcome Measure Information:
Title
Time to first request of postoperative rescue analgesics
Description
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
Title
Objective Pain Scale (OPS) up to 24 hours.
Description
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
Title
Perioperative hemodynamic parameters
Description
Heart rate
Time Frame
every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
Title
side effects
Description
number of patients who develop scalp hematoma in the GONB group
Time Frame
within 24 hours
Title
side effects
Description
number of patients who develop postoperative nausea and vomiting
Time Frame
within 24 hours
Title
Perioperative hemodynamic parameters
Description
systolic and diastolic arterial blood pressure.
Time Frame
every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA physical status I or II,
Glasgow Coma Scale (GCS) 15,
children scheduled for craniotomy for posterior fossa tumors
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.
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy
We'll reach out to this number within 24 hrs