Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001695146 Date of Approval: 24/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Paravertebral block versus caudal block using dexmedetomidine plus local anesthetics for inguinal hernia repair in pediatrics: a randomized prospectiv
Official scientific title Paravertebral block versus caudal block using dexmedetomidine plus local anesthetics for inguinal hernia repair in pediatrics: a randomized prospective trial
Brief summary describing the background and objectives of the trial Major pediatric abdominal surgeries result in postoperative pain ranging from moderate to severe. Many patients may have contraindication to one or more of the used analgesic techniques. Open abdominal surgeries lead to both incisional pain and visceral pain. Opioids used for postoperative analgesia may be associated with side effects such as hypoventilation, sedation, gastric dysmotility, nausea and vomiting, which can worsen patient recovery. Regional anaesthetic techniques can reduce intra-operative requirement of both inhaled and intravenous anaesthetic agents, allow more rapid recovery of the conscious level, and reduce postoperative pain, and systemic opioids use. Caudal block is the most popular regional anaesthetic techniques used to relieve moderate-to-severe postoperative pain in Children undergoing surgery of the lumbosacral to midthoracic dermatomal level. Paravertebral block (PVB) is a regional anaesthesia technique where local anesthetic is injected close to vertebra adjacent to the site where the spinal nerves emerge from the intervertebral foramina. Injection of local anaesthetics in this space leads to somatic and sympathetic nerve blockade in the same side which extends above and below the site of injection. Paravertebral block provides a good analgesia after thoracotomy and abdomen surgery. Dexmeditomidine is an Alpha (¿)-2-adrenergic receptor (¿2-AR) agonist.Adding dexmedetomidine to local anesthetics during regional anesthesia and peripheral nerve blockade procedures is proved to be efficacious for the surgical patient.The aim of the present study is to compare the effects of caudal block and paravertebral block using dexmedeto
Type of trial RCT
Acronym (If the trial has an acronym then please provide) no
Disease(s) or condition(s) being studied Anaesthesia,anesthesia for hernai repair in pediatric,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 17/03/2016
Actual trial start date 17/03/2016
Anticipated date of last follow up 16/09/2016
Actual Last follow-up date 16/09/2016
Anticipated target sample size (number of participants) 68
Actual target sample size (number of participants) 80
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
30851/03/16 research ethics committee, faculty of medicine, Tanta university, Egypt
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Permuted block randomisation Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ¿ Caudal group ( C group) Caudal blocks will be performed prior to surgery by the same anaesthesiologist, with patients in the lateral decubitus position. Patients in group (CB) will receive caudal bupivacaine (0.25%) 1 ml/kg and dexemetomidine 1mic/kg. 40
Experimental Group ¿ Paravereberal group (PVB group) for paravertebra block the needle will be inserted at the level of 2nd lumbar vertebra. The distance from the midline was 1 to 2 cm.After aspiration to be sure it is not intravascular, a bolus of 0.5 ml/kg of bupivacaine (0.25%) and dexmetomidine 1mic/kg will be injected 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Age 3-7 years ¿ ASA I ¿II ¿ Scheduled for elective unilateral inguinal hernia surgery Patients will be excluded from the study if they Have contraindication to regional anesthesia, such as ( infection at the site of injection, Coagulopathy or anticoagulation therapy, Congenital abnormalities of spine and meninges ,history of developmental delay or mental reterdation and allergy to local anaesthetics drugs). Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 7 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes research ethics committee, faculty of medicine,tanta university
Ethics Committee Address
Street address City Postal code Country
al bahr street tanta Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/03/2016 research ethics committee, faculty of medicine,tanta university
Ethics Committee Address
Street address City Postal code Country
al bahr street tanta Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - FLACC score. 15 min, 1h, 4, 8, 12, 16, 20, and 24 hours postoperative
Primary Outcome - The number of patient need rescue analgesia before discharge
Primary Outcome Total number of rescue analgesia will be used in the form of fentanyl before dicharge
Primary Outcome duration of postoperative analgesia The time from recovery to first dose of fentanyl (duration of postoperative analgesia
Secondary Outcome The parents' satisfaction before discharge
Secondary Outcome Any postoperative adverse events before discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
tanta university hospital al bahr street tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
tanta univerity hospital al bahr street tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor tanta university hospital al bahr street tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
hesham mohamed marouf hasan radwn street tanta Egypt
Naglaa khalil hasan radwan street tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hesham marouf heshammarouf@hotmail.com 00201274366808 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Principal Investigator naglaa khalil heshammarouf@hotmail.com 00201273547762 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Public Enquiries hesham marouf heshammarouf@hotmail.com 00201274366808 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
Role Name Email Phone Street address
Scientific Enquiries hesham marouf heshammarouf@hotmail.com 00201274366808 hasan radwan street
City Postal code Country Position/Affiliation
tanta Egypt
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information