Symptoms and General Pathology

All Conditions

Neoplasms

Nervous System Diseases

Pain, Postoperative

Pain

Infratentorial Neoplasms

Postoperative Complications

Neurologic Manifestations

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Bupivacaine

Morphine

Anesthetics, Local

Analgesics, Opioid

Narcotics

In this arm, after general anesthesia, before surgery and head pin placement, scalp block will be applied. Scalp block will be performed with bupivacaine (Marcaine 5 mg/mL, 0,5% bupivacaine); nervus supraorbitalis, nervus supratrochlearis, n. auriculotemporalis, nervus zygomaticotemporalis, nervus occipitalis majoris and minoris will be bilaterally blocked with 2-3 ml bupivacaine.

In this arm, after general anesthesia, before surgery, 20 ml 0,5% bupivacaine (Marcaine 5 mg/ml, 0,5% bupivacaine) will be infiltrated to head pin points and skin incision area.

In this arm, neither scalp block, nor local infiltration will be performed.

In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.

End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.

morphine patient controlled analgesia

Yusuf Tunali, Professor

This study evaluate the effects of scalp block versus local infiltration on haemodynamic response to head pin replacement and skin incision and postoperative analgesia in posterior fossa surgery

In this study 15 patients will receive scalp block with bupivacaine, 15 patients will receive local infiltration with bupivacaine and 15 patients will receive placebo before surgery. The haemodynamic response to head pin replacement and skin incision will be recorded. Postoperatively all patients will have a patient controlled analgesia (PCA) device containing morphine (1 mg/ml) for analgesia. Visual analogue scale (VAS) for pain evaluation, sedation scores, and also postoperative morphine consumption will be evaluated and recorded.

The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery

The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in

heart rates (beats per minute) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

Systolic arterial pressures (mmHg) will be recorded in before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

Diastolic arterial pressures (mmHg) will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

Mean arterial pressures (mmHg) will be recorded in will be recorded before induction, before block, before head pinning, head pinning, head pin 5. and 10. minutes, skin incision

pain scores (visual analogue score=VAS) will be evaluated.

morphine dosage used (mg) will be recorded in this time periods

Istanbul University

Staff anesthesiologist

Behaviors and Mental Disorders

Cognitive Dysfunction

Motor Skills Disorders

Mental Disorders

Psychotic Disorders

Neurodevelopmental Disorders

Training Group recieved cognitive and Motor training included 6 sessions using the following training devices.

* Dynavision D2 ® (USA) (https://products.dynavisioninternational.com/products/d2) presents a panel with 64 bulbs which take the form of five circles. The task of a participant is to press the bulb that is glowing as quick as possible. In the trial 8 modes will be used; they have different instructions which are aimed at visual-motor co-ordination, processing speed, inhibition, and shifting.
* Fitlight Trainer ® (Canada) (https://www.fitlighttraining.com) consists of 7 clickers, and the tasks are similar to Dynavision ones.
* NeuroTracker ® (Canada) (https://neurotracker.net) includes a task of multiple object training for working memory and attention enhancement.

Control Group didn't recieved any cognitive and motor training. They visited swimming pool and physical therapy.

In the first phase of the trial, all participants (patients and healthy children) will complete cognitive and motor functions assessment.

Then the sample of patients who have cognitive/motor impairment will be randomized to an either Intervention or Control group.

In the second phase of the trial, survivors in the Intervention Group will receive 6 sessions of cognitive and motor training during two weeks, and survivors in Control Group will undergo .....

After this treatment phase, motor and cognitive functions assessment will be conducted in all patients once again.

In the third phase, the Control Group will be provided the active intervention (i.e. 6 sessions of cognitive and motor training during two weeks), while the Intervention Group engages in passive reading.

After this, motor and cognitive functions assessment will be carried out in all patients once again.

Cognitive and Motor Training

The purpose of this study is to create a rehabilitation program for children who survived posterior fossa tumors using the latest technology. Supposed that training in Fitlight, Dynavision D2, NeuroTracker will improve executive functions, visual-motor integration, fine and gross motor functions.

The death rates from posterior fossa tumors (PFT) have declined significantly over the past decades. Children and adolescents who survived this kind of tumor without metastases demonstrate 5-year survival rates of 90%. Standard treatment for posterior fossa tumors includes surgical rejection, which can be combined with radiotherapy and chemotherapy. However, treatment factors can cause the impairment of motor and cognitive functions, which influence negatively speech, academic achievements, and quality of life. Such an outcome can be induced by tumor growth process as well. One of the most essential consequences of the disease is cognitive deficiency in the areas of attention, working memory, and executive functions.

The cerebellum pathology often causes deficits of motor skills. Considering that motor system has a hierarchal organization, PFT can cause the impairment of all the system, starting with gross motor skills and ending in the finest eye movements. The cerebellum has been shown to control voluntary eye movements, particularly such parameters as accuracy and velocity of saccades, fixation duration, etc.

Given the effect of probable deficits on a child's daily life, the issue of cognitive and motor remediation programs is in the spotlight today. There is some evidence that interventions targeting cognitive functions (e.g. working memory, short-term memory, attention, planning) and motor skills (gross and fine motor skills, muscle strength, agility) can be effective in these patients.

However, only few of remediation programs focus on visual-motor co-ordination and saccadic eye movements system, despite the fact that they provide the basis for higher-level functions, such as sustained attention, working memory, and planning.

The research conducted in Clinical Rehabilitation Research Center "Russkoe Pole" has revealed that treatment gains in the areas of motor skills, and specifically saccadic eye movements, are positively associated with the enhancement of attention and working memory. Given this, the investigators can suggest that this improvement is connected with the reduction of extra saccadic movements and consequently the decrease of irrelevant information to be processed. This mechanism can be generalized to the other executive functions, such as shifting, inhibition, and planning.

This trial will allow the investigators to determine potential feasibility of rehabilitation program targeting motor and cognitive functions, as well as the saccadic system, in pediatric posterior fossa tumor survivors.

Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors

The Effect of Cognitive and Motor Training on Executive Functions, Motor Skills, and Saccadic Eye Movements System in Pediatric Posterior Fossa Tumor Survivors

The software product, within which the interaction between patients and specialists will be realized, is supposed to be created in the Splunk system. The system allows to search both the real-time data and the archived data, based on the results of the search Splunk gives you the opportunity to: analyze the results with the visualization tools, generate reports and warnings, create a monitoring and notification systems in real time. These can be expanded - you can create new applications using the specialized development platform that comes with Splunk. The study will be attended by at least 1000 patients and their families who have concluded an agreement with the Medical-Rehabilitation Scientific Center "Russe pole", and come to the examination at least 2 times a year.

Following outcomes are mesuared: Execution time, Number of Fixations, Scan Path, Mean Duration of Fixations, Mean Saccades Amplitude, Ellipse Square

Following outcomes are mesuared: Visual-motor integration, Visual perception, Motor coordination.

Following outcome are mesuared: Reaction Time

Following outcomes are mesuared: Pattern Recognition Memory Immediate, Pattern Recognition Memory Delayed, Spatial Recognition Memory, Spatial Working Memory (Mistakes), Spatial Working Memory (Strategy), Spatial Span, Rapid Visual Processing (Mistakes), Rapid Visual Processing (Median Latency)

Following outcomes are mesuared: Fine Motor Skills, Gross Motor Skills, Coordination, Strength and Agility, General Score

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Diseases and Abnormalities at or Before Birth

Rare Diseases

Congenital Abnormalities

Arnold-Chiari Malformation

Spinal Dysraphism

Neural Tube Defects

Nervous System Malformations

Chiari Malformation Type 2

Antipyretics

Acetaminophen

Analgesics, Non-Narcotic

IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)

normal saline (placebo control) 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)

IV acetaminophen

normal saline 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)

normal saline

Srijaya K Reddy, MD, MBA

Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children. However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in children undergoing posterior fossa surgery. In this prospective, randomized controlled trial, the investigators aim to determine whether the addition of IV acetaminophen for 24 hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical procedures of the posterior fossa compared with conventional therapy.

The primary goal of this study is to compare the efficacy of IV acetaminophen to placebo in pediatric patients undergoing posterior fossa surgery, with the primary outcome measure being postoperative opioid requirements (morphine equivalent mg/kg). This will be a prospective, randomized, double blind control trial. The patient, research team, surgeon, and anesthesiologist will all be blinded to the patient's treatment group. Patients will receive either IV acetaminophen or equal volume normal saline (placebo) in the perioperative period.

The interventional component of this study involves the intraoperative and postoperative administration of IV acetaminophen. Intraoperative and postoperative data pertaining to adverse events would be collected for safety monitoring purposes.

Enrolled subjects will be randomized to receive either IV acetaminophen or equal volume saline placebo during surgery and for 24 hours postoperatively. According to a computer-generated table of random number assignments, each patient will be randomly assigned to receive one of the following two treatment groups:

Treatment group 1:

IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively). This dosing regimen was chosen based on pharmacokinetic data and recommended dosing guidelines for IV acetaminophen in children 2 to 12 years of age.

Treatment group 2:

Equal volume of normal saline (placebo control) at the same dose and frequency as treatment group 1.

Loading dose volumes and subsequent doses every 6 hours will be determined based on weight of the patient such that they will receive equal volumes of either IV acetaminophen or saline.

Maintenance of anesthesia, including opioid administration, and perioperative management will proceed as per routine care.

POSTOPERATIVE ANALGESIA

At the completion of surgery, the anesthetic agents will be discontinued as per routine care. Per routine care, after tracheal extubation, morphine (0.05 mg/kg/dose) will be administered as needed by the blinded assessor until the patient appears comfortable, defined as the absence of any verbal or behavioral expression of pain. Patients will then be transferred to the intensive care unit (ICU).

Time of entry into the intensive care unit will be recorded. The following assessments will be recorded at time of admission to the ICU:

* vital signs (heart rate, respiratory rate, blood pressure)
* oxygen saturation
* pain score
* sedation score

As part of routine care for postoperative analgesia, patients will receive morphine sulfate at standard doses (0.05 - 0.1 mg/kg/dose every 3 hours as needed for pain). The frequency and dose of morphine will be adjusted according to the patient's pain score, with a goal to maintain a pain score of \< 6. In addition, patients will transition to oral opioids as soon as their diet allows.

The following parameters will be used to measure short-term postoperative analgesia and side effects:

* Daily opioid consumption (mg/kg/24h in morphine equivalent using the conversion)
* Pain scores at rest
* Sedation score
* The incidence of post-operative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics: i.e. ondansetron or promethazine given as needed.
* The incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic: i.e. diphenhydramine or hydroxyzine given as needed for pruritus
* The incidence of pyrexia (defined as core temperature ≥ 38º Celsius). Ketorolac will be administered 0.5 mg/kg q6h prn as needed for pyrexia as per routine care.

Data collection will continue for up to 72 hours postoperatively.

DATA ANALYSIS

Data will be analyzed to determine the decrease in postoperative opioid requirements with or without IV acetaminophen after posterior fossa surgery as the primary outcome. The investigators hypothesize that IV acetaminophen will decrease postoperative opioid requirements, pain and sedation scores, and opioid-induced side effects in children undergoing posterior fossa surgery.

Efficacy of Acetaminophen in Posterior Fossa Surgery

Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery

Equianalgesic conversion of opioid consumption to morphine equivalent will be used

Scores range from 0 \[no pain\] to 10 \[worst possible pain\]

Score range from 0 \[completely awake\] to 4 \[asleep but not responsive to any stimuli\]

1. Incidence of postoperative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics (i.e. ondansetron or promethazine given as needed)
2. Incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic (i.e. diphenhydramine or hydroxyzine given as needed for pruritus)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Effects of Scalp Block on Haemodynamic Response and Postoperative Pain in Posterior Fossa Surgery	NCT02852382	Posterior Fossa...	Bupivacaine morphine patien...	16 Years - 70 Years	Istanbul University
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Efficacy of Acetaminophen in Posterior Fossa Surgery	NCT02532322	Arnold-Chiari M... Posterior Fossa...	IV acetaminophe... normal saline	2 Years - 12 Years	Children's National Research Institute
Efficacy of Acetaminophen in Posterior Fossa Surgery	NCT02532322	Arnold-Chiari M... Posterior Fossa...	IV acetaminophe... normal saline	2 Years - 12 Years	Children's National Research Institute
Efficacy of Acetaminophen in Posterior Fossa Surgery	NCT02532322	Arnold-Chiari M... Posterior Fossa...	IV acetaminophe... normal saline	2 Years - 12 Years	Children's National Research Institute
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Cognitive and Motor Training in Pediatric Posterior Fossa Tumor Survivors	NCT03951246	Childhood Cance... Cognitive Impai... Motor Skills Di... Posterior Fossa...	Cognitive and M...	6 Years - 17 Years	Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Spots Global Cancer Trial Database for posterior fossa tumors