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.: PACTR202311549336413 Date of Approval: 14/11/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study between Analgesic Effect of Scalp Block using Bupivacaine and Lidocaine versus Scalp Block using Magnesium as an Adjuvant to Bupivacaine and Lidocaine in Patients undergoing Chronic Subdural Hematoma Evacuation Surgery
Official scientific title A Comparative Study between Analgesic Effect of Scalp Block using Bupivacaine and Lidocaine versus Scalp Block using Magnesium as an Adjuvant to Bupivacaine and Lidocaine in Patients undergoing Chronic Subdural Hematoma Evacuation Surgery: A Double Blinded Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Chronic subdural hematoma evacuation is usually accompanied with moderate to severe postoperative pain; moreover, untreated postoperative chronic subdural hematoma evacuation pain leads to delay in the recovery after surgery, longer hospital stay, chronic pain, increase in the chance of venous thrombosis, and patient dissatisfaction. Administration of opioid for treatment of acute pain after chronic subdural hematoma evacuation is not preferred for patients undergoing neurosurgical procedures due to variety of adverse effects including nausea, vomiting, dizziness, respiratory depression, hypoventilation and sleep breathing problems. All of which can interfere with conscious level and increase intracranial tension. Hence regional analgesia techniques are an integral part of opioid-sparing analgesia after chronic subdural hematoma evacuation. Scalp nerve block is the principal modality of regional anesthesia used for awake craniotomy and to provide postoperative analgesia. This study was conducted to assess the safety and efficacy of scalp block using bupivacaine and lidocaine compared to scalp block using magnesium sulfate as an adjuvant to bupivacaine and lidocaine in patients undergoing chronic subdural hematoma evacuation surgery. A total of 38 patients with chronic subdural hematoma scheduled for evacuation surgery were included and were randomized to two groups. Group 1 received scalp block using bupivacaine and lidocaine, whereas Group 2 received the scalp block using magnesium sulfate as an adjuvant to bupivacaine and lidocaine.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/11/2022
Actual trial start date 10/11/2022
Anticipated date of last follow up 31/03/2023
Actual Last follow-up date 31/03/2023
Anticipated target sample size (number of participants) 38
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Scalp block with magnesium sulfate adjuvant After induction of general anesthesia and intubation The scalp block was performed bilaterally after intubation using a 20-gauge needle. The higher dose limits of LA were calculated individually for each patient as 2-3 mg/kg for bupivacaine (0.25%) and 4.5 mg/kg for lidocaine (1%). Magnesium sulfate was added to the local anesthetic mixture (500 mg, 5 ml). Circumferential scalp block was performed using 3-5 mL of LA for each of the branches responsible for sensory supply of the forehead and scalp including supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves. 19
Control Group Scalp block without magnesium sulfate adjuvant After induction of general anesthesia and intubation The scalp block was performed bilaterally after intubation using a 20-gauge needle. The higher dose limits of LA were calculated individually for each patient as 2-3 mg/kg for bupivacaine (0.25%) and 4.5 mg/kg for lidocaine (1%). Circumferential scalp block was performed using 3-5 mL of LA for each of the branches responsible for sensory supply of the forehead and scalp including supraorbital, supratrochlear, zygomaticotemporal, auriculotemporal, greater occipital, and lesser occipital nerves. 19 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients (males and females) undergoing chronic unilateral subdural evacuation surgery ASA II or ASA III Glasgow coma score 14 or 15 Age ≥ 45 years Patient refusal or first-degree relative refusal Patients who needed postoperative ventilation History of allergy to local anesthetics Glasgow coma score ≤ 13 Failed block, more than 2 doses rescue analgesia within the 1st hour postoperative Advanced cardiac lesion Local sepsis 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 85 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 02/11/2022 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Time to first dose of postoperative analgesia It was assessed during 24 h postoperatively and the time the patient asks for analgesia was recorded
Secondary Outcome Heart rate Preoperative, at extubation, after extubation at 5 min, 30 min, 2 h, 4 h, 8h, 12h, 18, and 24 h postoperatively
Secondary Outcome Systolic, diastolic, and mean blood pressure Preoperative, at extubation, after extubation at 5 min, 30 min, 2 h, 4 h, 8h, 12h, 18, and 24 h postoperatively
Secondary Outcome Pain using the VAS VAS after extubation at 5 min, 30 min, 2 h, 4 h, 8h, 12h, 18h, and 24 h postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Alainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Omar Wagih Abbas Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Omar Abbas omar.wagih.abbas@mail.com 000000000000000 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Mahmoud mohamed.mahmoud22@mail.com +201003714635 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud mohamed.mahmoud22@mail.com +201003714635 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication On reasonable request the data will be available through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
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