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.: PACTR202402918570584 Date of Approval: 06/02/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Effect of Ultrasound Versus Fluoroscopy Guided Erector Spinae Plane Blocks on Postoperative Pain Control in Lumbar Spine Surgery: Single-Blinded Randomised Clinical Trial.
Official scientific title The Effect of Ultrasound Versus Fluoroscopy Guided Erector Spinae Plane Blocks on Postoperative Pain Control in Lumbar Spine Surgery: Single-Blinded Randomised Clinical Trial.
Brief summary describing the background and objectives of the trial Background and Rationale: Postoperative pain is common complication of lumbar surgery, Which necessitates the administration of large intravenous doses of opioids, that can lead to significant complications. This pain has a negative impact on patient satisfaction with the surgery, and can impede postoperative recovery, mobility, and hospital discharge. Erector spinae plane block (ESPB), at which local anaesthetic are injected into the fascial plane between the transverse process of the vertebra and the erector spinae muscles. It has gained popularity in perioperative analgesia for various surgeries, including breast, thoracic, abdominal, and lumbar spine surgeries. to perform this block we need to identify the transverse processes of the spine and then inject the local anaesthetic between the transverse process and the erector spinae muscles. Identification of the transverse process is done either by ultrasound, fluoroscopy or anatomical landmarks. Local anaesthetics in the ESP block spread to the upper and lower parts of the interfascial plane between the erector spinae muscle and the transverse process. Local anaesthetic can also spread to costotransverse junctions and permeates the paravertebral space. Despite numerous publications on the subject, there are still discrepancies in the technique, regarding local diffusion of anaesthetics and mechanisms of action. This study will compare diffusion of local anaesthetics in an ESP block under ultrasound and fluoroscopic procedures, as well as potential mechanisms of action. Objectives: The Purpose of the study is to compare the analgesic effect of local anaesthetic in ESP block under ultrasound and fluoroscopy in patients undergoing lumbar spine surgery. Using The Visual Analogue Scale (VAS).
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 30/06/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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
Control Group Fluoroscopy group 15 ml of 0.25% bupivacaine each side 24 hours After identification of transverse processes of the level operated by fluoroscopy by AP view, about 0.4 mg Dexamethasone and 15 cc's of 0.25% bupivacaine. Prior to injection, 14.5 cc of contrast (omnipaque 350) will be added to the block cocktail for easy radiographic identification then attached to a 22-gauge spinal needle via extension IV tubing. In order to access tip of the transverse process (the most lateral part of it), the spinal needle will be advanced under fluoroscopic guidance parallel to the rays. After negative aspiration is done, 30cc will be delivered in the subfascial plane. 25 Active-Treatment of Control Group
Experimental Group Ultrasound group 15 ml 0.25% bupivacaine each side 24 hours After sterilisation of the ultrasound probe and the region scheduled for the procedure, the probe will be installed in the sagittal axis in the midline at the L3 vertebral level. The spinous processes will be first visualised, after which the probe will be lateralized, and the transverse processes and the erector spinae muscle will be visualised lateral to the midline. A 10cm Quincke needle will be inserted from the cranial to the caudal portion using the in plane technique. The needle will be advanced between the transverse process and the deep fascia of the erector spinae muscle. The location of the needle will be confirmed with 2 mL saline solution, after which 0.4 mg Dexamethasone and 15 cc's of 0.25% bupivacaine will be administered. The same procedure will also be performed on the opposite side 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
● Physical status ASA I and ASA ll. ● Both males and females Age older than or equal 18 Years. ● Patients undergoing lumbar spine surgery for single level disc (discectomy and laminectomy). ● Duration of operation less than or equal 3 hrs Patient refusal. ● Patients below 18 years old. ● Patients with a history of allergy to opioids or contrast local anaesthetics and medium (Iohexol). ● Patients undergoing revision surgery. ● Patients having surgery for trauma, tumour, or infection. ● Pre-existing peripheral neuropathies and coagulopathy. ● Patients who developed intraoperative surgical complications (e.g dural tear). Adult: 19 Year-44 Year 18 Year(s) 65 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 18/12/2023 Cairo University research committee
Ethics Committee Address
Street address City Postal code Country
1 kasr alainy street cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome First time to seek analgesia postoperative (starting from transferring the patient to PACU). 0, 4, 8, 12, 16, 20, 24 hours
Secondary Outcome Postoperative pain score, using The Visual Analogue Scale (0 to 10) to be assessed every 4 hours. ○ Total analgesic consumption of morphine postoperative (in miligrams) for 24 hours postoperative. ○ The incidence of postoperative nausea and vomiting. ○ Length of hospital stay (in hours). ○ Time taken in minutes (starting from optimization of image either by US or Fluoroscopy to end of injection) 0, 4, 8, 12, 16, 20, 24 hours
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
Cairo University 1 Kasr Alainy street Cairo 11358 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo university 1 kasr alainy street cairo 11358 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Mahmoud dr_mo_mahmoud@yahoo.com +201003714635 12 zahraa maadi
City Postal code Country Position/Affiliation
cairo Egypt assistant professor of anaesthesia
Role Name Email Phone Street address
Principal Investigator naser fadel drnaserfadel@yahoo.com +201222477048 18 manial
City Postal code Country Position/Affiliation
cairo Egypt professor of anaesthesia
Role Name Email Phone Street address
Scientific Enquiries amira salama amira.salama95@gmail.com +201001155852 18 kasr alainy
City Postal code Country Position/Affiliation
cairo Egypt master degree in anaesthesia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available (including data dictionaries), All of the individual participant data collected during the trial, after deidentification. all documents for anyone who wishes for any purpose after publication via a link provided. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol start March 2024 complete June 2024 publish August 2024 all IPD and any additional supporting information will be shared with all research team members and principal investigator, clinical analysis team, platform of clinical registry.
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