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

NCT03762343 | Completed Phase 3

• 1 other identifier: N-11/s /2015/MD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Fossa Tumor

Keywords

greater occipital nerve block; posterior fossa; ultrasound; pain; craniotomy

Outcome Measures

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.

  at 12 hours postoperative

Secondary Outcomes (6)

• Time to first request of postoperative rescue analgesics

  within 24 hours

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

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

• Perioperative hemodynamic parameters

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

• side effects

  within 24 hours

• side effects

  within 24 hours

Study Arms (2)

Greater occipital nerve block group (group GONB)

EXPERIMENTAL

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

Control group (group C):

PLACEBO COMPARATOR

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

Drug: control group C

Interventions

ultrasound guided Greater occipital nerve block DRUG

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.

Greater occipital nerve block group (group GONB)

control group C DRUG

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

Control group (group C):

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Infratentorial Neoplasms; Pain

Condition Hierarchy (Ancestors)

Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, SICU and pain management

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 3, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 15, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)