Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery (ITVSEpidural)

Safety and Analgesic Efficacy of Spinal Versus Caudal Block in 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%; Drug: caudal plain bupivacaine 2.5mg/kg 0.25%

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Assiut Governorate
    • Assiut, Assiut Governorate, Egypt, 715715
      • Hala Saad Abdel-Ghaffar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Spinal group; 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%; 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
Active Comparator: Caudal group; 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%; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC Score	FLACC scores will be recorded.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total consumption of rescue analgesics	The total consumption of postoperative rescue analgesics will be recorded.	24 hours
Postoperative Agitation	Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.	60 min.
Adverse effects	Any adverse effect will be treated and recorded.	24 hours
Residual motor paralysis	By the Modified Bromage scale	6 hours

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Hala S Abdel-Ghaffar, MD, Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): January 13, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: IRB00008718/36800

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No