Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

NCT02988700 | Completed Phase 2 DMC

• 1 other identifier: IRB00008718/36800
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• FLACC Score

  FLACC scores will be recorded.

  24 hours

Secondary Outcomes (4)

• Total consumption of rescue analgesics

  24 hours

• Postoperative Agitation

  60 min.

• Adverse effects

  24 hours

• Residual motor paralysis

  6 hours

Study Arms (2)

Spinal group

ACTIVE COMPARATOR

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 .

Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%

Caudal group

ACTIVE COMPARATOR

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.

Drug: caudal plain bupivacaine 2.5mg/kg 0.25%

Interventions

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.

Also known as: Marcain

Spinal group

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.

Also known as: Bucain

Caudal group

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; bucain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hala S Abdel-Ghaffar, MD

  Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.

Study Record Dates

• First Submitted: November 25, 2016
• First Posted: December 9, 2016
• Study Start: November 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 13, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)