ITVSEpidural: Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT02988700

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5% Drug: caudal plain bupivacaine 2.5mg/kg 0.25%	Phase 2/Phase 3

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).

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Nov 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

FLACC Score [24 hours]
FLACC scores will be recorded.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hala Saad Abdel-Ghaffar	Assiut	Assiut Governorate	Egypt	715715

Sponsors and Collaborators

Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hala Saad Abdel-Ghaffar, Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt., Assiut University

ClinicalTrials.gov Identifier:

NCT02988700

Other Study ID Numbers:

IRB00008718/36800

First Posted:

Dec 9, 2016

Last Update Posted:

Jan 13, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Pain, Postoperative

Bupivacaine

Study Results

No Results Posted as of Jan 13, 2021