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.: PACTR201605001635250 Date of Approval: 17/05/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title scalp block for tissue expander surgery
Official scientific title Selective scalp nerve block: An adjuvant technique with tissue expansion in post-burn pediatric alopecia.
Brief summary describing the background and objectives of the trial SNB provides hemodynamic stability when performed with general anesthesia and may result in less supplemental intravenous or volatile anesthetics as it attenuates the sympathetic stimulation and surgical stress response (7, 8, 9). SNB provides postoperative analgesia and greatly reduces the need for opioids during the first 24 hours postoperatively for procedures such as awake craniotomies, insertion of the skull pins, awake stereotactic surgery and plastic procedures of the scalp with extensive dissection of the myocutaneous tissue. SNB was been successfully utilized in children . For SNB, anatomical identification of the nerves will be done by bony landmarks palpation . SNB is easy to perform and has a minimal risk of side effects with expert hands (7). As with any regional block; there is a risk associated with applying the local anesthetic includes intravascular injection and infection at the site of injection . Specific complications of SNB include neurologic deficits such permanent nerve damage, due to unintentional injection of local anesthetic directly into the nerve. Additionally, temporally motor facial nerve block could occur specifically during auriculotemporal nerve block due to paralysis of the facial muscles which will be reversed completely after the expected duration of action of the used local anesthetic. Those complications could be prevented by using the proper technique, avoid deeper infiltration than the bony landmark (epically above the zygoma) and injection of the recommended amount of local anesthetic . In this study a comparison between preoperative bilateral SNB and no intervention will be done before scalp tissue expander insertion for burn-induced hair loss. The primary goal is the efficacy of postoperative analgesia with the hypothesis that; SNB will have more intraoperative hemodynamic stability, less intraoperative blood loss and less postoperative analgesic doses during the first 24 hours.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/11/2015
Actual trial start date 04/11/2015
Anticipated date of last follow up 01/06/2016
Actual Last follow-up date 01/06/2016
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL no url yet
Secondary Ids Issuing authority/Trial register
protocol number R15.10.18 local ethical committee /Mansoura faculty of medicicne
protocol number R15.10.18 local ethical committee /Mansoura faculty of medicicne
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
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomization using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group control expander insertion no block will be performed no block control 10 Placebo
Experimental Group scalp block for expander insertion 20 mL of a mixture 0.25% bupivacaine plus 4 µg/mL adrenaline in 0.9% normal saline After general anesthesia till the postoperative period For SNB group; a 20-mL syringe filled with 20 mL of a mixture 0.25% bupivacaine plus 4 µg/mL adrenaline in 0.9% normal saline connected via flexible tubing to a 25-gauge needle will be prepared and used under complete aseptic technique after scalp skin sterilization. Bilateral block of supratrochlear, supraorbital, auriculotemporal, lesser occipital and greater occipital nerves will be done and 2 10 Active-Treatment of Control Group
Control Group control expander removal no block will be performed no block no block 10 Active-Treatment of Control Group
Experimental Group scalp block for expander removal 20 mL of a mixture 0.25% bupivacaine plus 4 µg/mL adrenaline in 0.9% normal saline 2ml for each nerve After general anesthesia till the postoperative period For SNB group; a 20-mL syringe filled with 20 mL of a mixture 0.25% bupivacaine plus 4 µg/mL adrenaline in 0.9% normal saline connected via flexible tubing to a 25-gauge needle will be prepared and used under complete aseptic technique after scalp skin sterilization. Bilateral block of supratrochlear, supraorbital, auriculotemporal, lesser occipital and greater occipital nerves will be done and 2 10 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.patients more than 10 years old 2. ASA physical status I and II 3. patients scheduled for an elective scalp tissue expander insertion or removal after burn induced hair loss will be included in this study. 1 Patients with neuromuscular disease 2 Severe cardiovascular disease 3 Any contraindications to regional anesthesia as: patient refusal, coagulation abnormality, known allergy to local anesthetics or infection at the injection site 10 Year(s) 50 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 Local Ethical committee Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The effect of scalp nerve block on analgesia during tissue expander surgery and during the postoperative period during surgery Pain will be evaluated at 0 2 4 6 8 12 24 hours postoperatively
Secondary Outcome operative bleeding immediately after surgery
Secondary Outcome total opioid consumption in the first 24 hours after 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
plastic and burn center in Mansourah university hospitals , Mansourah university Elgmhoria street Elmansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University hospitals Elgmhoria street Elmansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University hospitals Elgmhoria street Elmansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Alaa Elmaadawy Elgmhoria street Elmansourah 35516 Egypt
Dr MAHA ABO-ZEID Elgmhoria street Elmansourah 35516 Egypt
Prof Ahmed Elsabbagh Elgmhoria street Elmansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAHA ABO-ZEID mahazed@yahoo.com 0020114226976 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Alaa Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Alaa Elmaadawy a_maadawy@hotmail.com 00201153304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
REPORTING
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