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Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02988700
Acronym
ITVSEpidural
Enrollment
120
Registered
2016-12-09
Start date
2016-11-30
Completion date
2018-11-30
Last updated
2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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.

Interventions

DRUGIntrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%

The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.

DRUGcaudal plain bupivacaine 2.5mg/kg 0.25%

The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance give or pop will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
FLACC Score24 hoursFLACC scores will be recorded.

Secondary

MeasureTime frameDescription
Total consumption of rescue analgesics24 hoursThe total consumption of postoperative rescue analgesics will be recorded.
Postoperative Agitation60 min.Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
Adverse effects24 hoursAny adverse effect will be treated and recorded.
Residual motor paralysis6 hoursBy the Modified Bromage scale

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026