Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

NCT ID: NCT02988700

Last Updated: 2021-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-11-30

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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 .

Group Type: ACTIVE_COMPARATOR

Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

caudal plain bupivacaine 2.5mg/kg 0.25%

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Marcain; Bucain

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hala Saad Abdel-Ghaffar

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hala S Abdel-Ghaffar, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Hala Saad Abdel-Ghaffar

Asyut, Assiut Governorate, Egypt

Countries

Egypt

Other Identifiers

IRB00008718/36800

Identifier Type: -

Identifier Source: org_study_id