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.: PACTR202305897532790 Date of Approval: 10/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic efficacy of different scalp block techniques for supratentorial craniotomy under general anesthesia; a prospective randomized controlled study
Official scientific title Analgesic efficacy of different scalp block techniques for supratentorial craniotomy under general anesthesia; a prospective randomized controlled study
Brief summary describing the background and objectives of the trial Pain following craniotomies has been largely investigated and reported that it could be moderate or severe during postoperative period. Postoperative pain treatment might help to prevent rise in intracranial pressure as well as reduce the risk of intracerebral hemorrhage. Combination of systemic analgesics and local anesthetics might reduce the amount of systemic opioids, thereby lower the incidence of opioids adverse effects, such as sedation, miosis, respiratory depression, nausea and vomiting. For this purpose; scalp block and local anesthetic infiltration have been used with systemic opioid administration. Scalp block (RSB) technique has become increasingly used as adjunct to systemic analgesia for intracranial surgery. Regional scalp block technique has been classically described as nerve targeted infiltration of 2-3 ml of local anesthetic solution at multiple sites with a 32–25 G needle. To the best of our knowledge, this is the first prospective, randomized, double blinded, controlled study to describe and evaluate this new technique of performing scalp block by continuous infiltration of nerves supplying the scalp. The objective of this trial is to evaluate the efficacy of two different techniques of scalp block in patients undergoing elective supratentorial craniotomy. The hypothesis is that a scalp block by continuous infiltration technique more effective than nerve targeted technique as regard reduction of intraoperative and postoperative opioid consumption and reducing postoperative pain scales.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Nervous System Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial 2 different techniques of Scalp block as analgesia during supratentorial cranitomy
Anticipated trial start date 14/05/2023
Actual trial start date 11/05/2023
Anticipated date of last follow up 12/01/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
R.23.03.2110 Mansoura Faculty of Medicine Institutional Research Board
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group No scalp block but pain will be managed by addtional doses of intravenous fentanyl increments of 50 micrograms intavenous fentanyl for the duration of surgery and for 24 hours postoperative No scalp block but pain will be managed by addtional doses of intravenous fentanyl 24 Active-Treatment of Control Group
Experimental Group Nerve targeted Scalp block 0.5% bupivacaine once after induction of anaesthesia and before surgery individula nerves of the scalp will be selectively blocked. Using 24 G needle; Supraorbital and supra-trochlear nerves will be blocked bilaterally with 6 mL bupivacaine 0.5%, injected above the midline of the eyebrow, perpendicular to the skin. Auriculotemporal nerves will be blocked bilaterally with 4 mL bupivacaine 0.5% injected 1.5 cm anterior to the ear at the level of tragus, the needle will be introduced perpendicular to the skin and injection will be performed deep to the fascia and superficially as the needle is withdrawn. The postauricular branches of the greater auricular nerves will be blocked bilaterally with 2 mL bupivacaine 0.5% injected to 1 cm posterior to the ear at the level of tragus, between bone and skin. The greater, lesser and third occipital nerves will be blocked bilaterally with 8 mL bupivacaine 0.5% injected along the superior nuchal line, approximately midway between the occipital protuberance and mastoid process. 24
Experimental Group Continous infiltration scalp block 0.5% Bupivacaine once after induction of anaesthesia and before surgery scalp block will be done by a continuous line of subcutaneous infiltration sing 0.5% bupivacaine with 24 G needle. The line of infiltration is defined by connecting the following points: a point in mid line 1 cm above the glabella, a point above the midpoint of the eye brow, a point midway between lateral palpebral fissure and tragus and last point 1 cm in front of the ear at the level of tragus. In addition to the continuous line of infiltration, the postauricular, greater, lesser and third occipital nerves are blocked in the same technique as in nerve targeted scalp block group 24
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
18-70 years old male or female ASA I, II & III scheduled for elective supratentorial craniotomy Refusal to participate Allergy to bupivacaine or fentanyl chronic hypertension Coronary artery disease Arrhythmia Cerebrovascular disease Increased intracranial tension Trigeminal neuralgia Previous craniotomy Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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
No 01/04/2023 Mansoura Faculty of Medicine Institutional Research Board
Ethics Committee Address
Street address City Postal code Country
El Gomhouria Street, El Mansoura, Dakahlia Governorate, Egypt Mansoura 35516 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 01/05/2023 Medical Research Ethics committee Institutional Review Board Mansoura Faculty of Medicine Mansoura University
Ethics Committee Address
Street address City Postal code Country
Institutional Review Board Office Building A Ground floor Mansoura Faculty of Medicine Mansoura University El Gomhouria Street, El Mansoura, Dakahlia Governorate Mansooura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Additional doses of fentanyl given intraoperatively after that given during induction. At the end of surgery
Secondary Outcome Heart rate [HR] and invasive mean arterial blood pressure [MAP] before induction of anesthesia, after induction of anesthesia, after pin head holder application, after skin incision, after dural incision, and after the closure of skin.
Secondary Outcome Time between end of surgery and extubation After extubation
Secondary Outcome Duration of surgery in minutes At the end of surgery
Secondary Outcome Time of first rescue analgesia from end of suegery till first rescue analgesia given
Secondary Outcome Cumulative doses of fentanyl given during the first 24 postoperative hours 24 hours postoperative
Secondary Outcome Post operative pain scale 0-10 points scale 1h, 2h, 6h, 12h, 18 h, 24 h after extubation
Secondary Outcome Postoperative complication including nausea, vomiting, pruritus and respiratory depression will be recorded during first 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Hospital El Gomhouria Street, El Mansoura, Dakahlia Governorate, Egypt Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self Funded Malllawany street, Bashtameer, West Mansoura Mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University El Gomhouria Street, El Mansoura, Dakahlia Governorate, Egypt Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Sayedalahl sayedalahl700@mans.edu.eg 0021004973663 Malllawany street, Bashtameer, West Mansoura, Egypt
City Postal code Country Position/Affiliation
Mansoura 35511 Egypt Lecturer of anesthesia
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com 00201064203475 El Gomhouria Street, El Mansoura, Dakahlia Governorate
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Rania Almohamdy raniaelmohamady@gmail.com +201003689480 El Gomhouria Street, El Mansoura, Dakahlia Governorate
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol, statistical analysis plan, Clinical Study report & analytical code will be available for sharing after deidentification by exclusion of personal data. Analytic Code,Clinical Study Report,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers authorities covered by relevant ethical committee, and will have a Data Sharing Agreement (DSA). For more information or to submit a request, please contact; sayedalahl700@mans.edu.eg
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information