Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery
- Conditions
- Pain, Postoperative
- Interventions
- Drug: caudal plain bupivacaine 2.5mg/kg 0.25%Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
- Registration Number
- NCT02988700
- Lead Sponsor
- Assiut University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Age: 2-12 years.
- Weight: 15-40 kg.
- Sex: both males and females.
- ASA physical status: 1-II.
- Operation: surgery below umbilicus.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Caudal group caudal plain bupivacaine 2.5mg/kg 0.25% caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that 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. Spinal group Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that 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. be given by .
- Primary Outcome Measures
Name Time Method FLACC Score 24 hours FLACC scores will be recorded.
- Secondary Outcome Measures
Name Time Method Total consumption of rescue analgesics 24 hours The total consumption of postoperative rescue analgesics will be recorded.
Postoperative Agitation 60 min. Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
Adverse effects 24 hours Any adverse effect will be treated and recorded.
Residual motor paralysis 6 hours By the Modified Bromage scale
Trial Locations
- Locations (1)
Hala Saad Abdel-Ghaffar
🇪🇬Assiut, Assiut Governorate, Egypt