Clinical trial NCT02988700: Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery
Official title: Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain, Postoperative
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Detailed description: The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia.

-Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol).

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide analgesia for approximately 4-6 hours.

Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide.

- The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Eligibility criteria: Inclusion Criteria:

* Age: 2-12 years.
* Weight: 15-40 kg.
* Sex: both males and females.
* ASA physical status: 1-II.
* Operation: surgery below umbilicus.

Exclusion Criteria:

* Allergic reaction to local anesthetics (LAs).
* Local or systemic infection (risk of meningitis).
* Coagulopathy.
* Intracranial hypertension.
* Hydrocephalus.
* Intracranial hemorrhage.
* Parental refusal.
* Hypovolemia.
* Spinal deformities, such as spina bifida or myelomeningocele.
* Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.

Primary outcomes:
measure: FLACC Score
timeFrame: 24 hours
Secondary outcomes:
measure: Total consumption of rescue analgesics
timeFrame: 24 hours
measure: Postoperative Agitation
timeFrame: 60 min.
measure: Adverse effects
timeFrame: 24 hours
measure: Residual motor paralysis
timeFrame: 6 hours
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Hala Saad Abdel-Ghaffar
state: Assiut Governorate
Study officials:
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
name: Hala S Abdel-Ghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References: