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Completed

NCT Number: NCT02988700

Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

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.

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Key information

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%

Drug

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.

Other names: Marcain

caudal plain bupivacaine 2.5mg/kg 0.25%

Drug

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.

Other names: Bucain

Primary outcomes

  1. FLACC Score

    Time frame: 24 hours

    FLACC scores will be recorded.

Secondary outcomes

  1. Total consumption of rescue analgesics

    Time frame: 24 hours

    The total consumption of postoperative rescue analgesics will be recorded.

  2. Postoperative Agitation

    Time frame: 60 min.

    Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.

  3. Adverse effects

    Time frame: 24 hours

    Any adverse effect will be treated and recorded.

  4. Residual motor paralysis

    Time frame: 6 hours

    By the Modified Bromage scale

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: ITVSEpidural

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2016
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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