Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Pain, Postoperative Clinical Trial

— ITVSEpidural  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988700
• Other study ID #: IRB00008718/36800
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Intrathecal 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.
• caudal 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.

Locations

Country	Name	City	State
Egypt	Hala Saad Abdel-Ghaffar	Assiut	Assiut Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FLACC Score	FLACC scores will be recorded.	24 hours
Secondary	Total consumption of rescue analgesics	The total consumption of postoperative rescue analgesics will be recorded.	24 hours
Secondary	Postoperative Agitation	Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.	60 min.
Secondary	Adverse effects	Any adverse effect will be treated and recorded.	24 hours
Secondary	Residual motor paralysis	By the Modified Bromage scale	6 hours