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

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ClinicalTrials.gov Identifier: NCT03762343
Recruitment Status : Active, not recruiting
First Posted : December 3, 2018
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital

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.


Condition or disease Intervention/treatment Phase
Posterior Fossa Tumor Drug: ultrasound guided Greater occipital nerve block Drug: control group C Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Official Title: Ultrasound-guided Greater Occipital Nerve Block in Children Undergoing Posterior Fossa Craniotomy: Randomized, Controlled Study
Actual Study Start Date : January 2016
Actual Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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
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.

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




Primary Outcome Measures :
  1. Objective Pain Scale (OPS) at 12 hours postoperative. [ Time Frame: 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 :
  1. Time to first request of postoperative rescue analgesics [ Time Frame: within 24 hours ]
    the time interval between the onset of GONB and the first request to postoperative analgesia and or OPS score ˃2- 3".

  2. Objective Pain Scale (OPS) up to 24 hours. [ Time Frame: at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively ]

    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.

  3. Perioperative hemodynamic parameters [ Time Frame: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively ]
    Heart rate

  4. side effects [ Time Frame: within 24 hours ]
    number of patients who develop scalp hematoma in the GONB group

  5. side effects [ Time Frame: within 24 hours ]
    number of patients who develop postoperative nausea and vomiting

  6. Perioperative hemodynamic parameters [ Time Frame: every 30 minutes intraoperative and at 2, 4, 6, 8, 12, 16, and 24 hours postoperatively ]
    systolic and diastolic arterial blood pressure.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Khaled Abdelfattah Abdallah Sarhan, lecturer of anesthesia, SICU and pain management, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03762343     History of Changes
Other Study ID Numbers: N-11/s /2015/MD
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Khaled Abdelfattah Abdallah Sarhan, Kasr El Aini Hospital:
greater occipital nerve block
posterior fossa
ultrasound
pain
craniotomy
Additional relevant MeSH terms:
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Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases