Protocol summary

Summary
Written informed parental consent in a double blind randomized clinical trial, 66 infants (ASA I or II), undergoing inguinal hernia repair will be recruited in Tabriz Teaching Children Hospital during a 12-month period of time. We explained these two forms of regional anesthesia and their complications to the parents throughout the preoperative visits. All patients were given IV midazolam (0.03 mg/kg) before performing block.. Monitoring included pulse oximetry, electrocardiogram, and non-invasive blood pressure monitoring and precordial stethoscope. A maintenance IV 5% dextrose in was infused from the start of preoperative fasting time (4 hours prior to the operation). In group C, infants were in left lateral position with flexion of hip. A 22-gauge caudal needle was selected to perform the block. After negative aspiration test, we injected 1ml/kg of 0.25% Bupivacaine, with 20μg adrenaline 1:1000 in caudal space, then the infant was turned into supine position.Successful caudal anesthesia was defined as lack of sensation to pinch at the desired sensory level and paralysis of lower limbs after 15 minutes. In group S, an assistant seated the infant on a folded towel 10 cm above the operative table. The head was placed in neuter positional 2.5cm, 25-gauge Quincke spinal needle was inserted into L5-S1interspace. This approach was adopted to avoid potential damage to the conus medullaris terminating at L3 in infants. Subarachnoid placement was confirmed by free flow of CSF. With the needle stabilized, the local anesthetic solution i.e. 1mg/kg of 0.5% hyperbaric Bupivacaine, with 20μg adrenaline 1:1000 was rapidly injected. The patient was immediately positioned supine with a 20-30° head up tilt for two to three minutes, and then horizontally. Successful spinal anesthesia was defined as lack of sensation to pinch at the desired sensory level and paralysis of lower limbs after 2 minutes. In all patients, we recorded vital signs (systolic and diastolic blood pressure, heart rate and SpO2) before induction, after 10, 20, and 30 minutes of block, at the end of surgery, at the beginning of the recovery, 10 and 20 minutes of the recovery phase, and at the end of the recovery. We also recorded presence of apnea and need for analgesia at the post-operation period up to 24 hour. NIPS was used to assess pain score; consisting of six criteria: facial expression, cry, breathing pattern, arms and legs positions, and state of arousal. In group c 25 min after block and in group s just after block the surgery started. In the case of unsuccessful block general anesthesia was induced. The aim of this study was to compare complication and success rates of caudal block and spinal anesthesia in awake preterm infants undergoing inguinal hernia repair

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201102014041N4
Registration date: 2013-05-10, 1392/02/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-05-10, 1392/02/20
Registrant information
Name
Mahin Seyedhejazi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 2252
Email address
seidhejazie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2009-12-22, 1388/10/01
Expected recruitment end date
2011-01-21, 1389/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The success rate and complication of caudal block and spinal anesthesia for awake preterm infants undergoing inguinal repair
Public title
Caudal block & spinal block in neonate
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criterion: infants less than 5 kg candidate for inguinal hernia repair. Exclusion criteria: any contraindication to regional blocks in children; major malformation of the sacrum; meningitis and intracranial hypertension.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2009-11-16, 1388/08/25
Ethics committee reference number
8813

Health conditions studied

1

Description of health condition studied
Regional blocks in infants
ICD-10 code
K40.2
ICD-10 code description
Bilateral inguinal hernia, without obstruction or gangrene

Primary outcomes

1

Description
Pain
Timepoint
Two, 4, 6 and 8 hours postoperative
Method of measurement
Neonatal infant pain scale(NIPS)

Secondary outcomes

empty

Intervention groups

1

Description
In first group :caudal block by 1mg/kg of 0.25% bupivacaine plus 20µg adrenaline (group C)
Category
Prevention

2

Description
In second group: spinal block by 1mg/kg of 0.5% hyperbaric Bupivacaine, with 20μg adrenaline 1:1000 (group s)
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tabriz Children Hospital
Full name of responsible person
Dr.Mahin Seyedhejazi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Alireza Ostadrahimi
Street address
Tabriz University of Medical Sciences-Golgasht Ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com; seidhejazie@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com; seidhejazie@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mahin Seyedhejazi
Position
Associate Professor of Anesthesia
Other areas of specialty/work
Street address
Tabriz Children Hospital
City
Tabriz
Postal code
Phone
+98 41 1526 2250
Fax
Email
seidhejazie@yahoo.com; seidhejazie@tbzmed.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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