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.: PACTR201808145298962 Date of Approval: 21/08/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Analgesic effect of Thoracolumbar Interfascial Plane Block for spine surgery
Official scientific title Effect of Ultrasound-guided Thoracolumbar Interfascial Plane Block on the Analgesic Requirements in Patients Undergoing Spine Surgery Under General Anesthesia
Brief summary describing the background and objectives of the trial Spine surgeries are associated with severe postoperative pain which typically takes 3 days to subside. Adequate perioperative pain relief is important for the patient's early mobilization and uneventful postoperative course.Regional anesthesia has been shown to improve outcomes in several recent studies.In Ultrasound-guided thoracolumbar interfascial plane (TLIP) block a local anesthetic is injected into the fascial plane between the multifidus and longissimus muscles of the thoracolumbar spine at approximately the level of the third lumbar vertebra (L3), which targets the sensory component of the dorsal rami of the thoraco-lumbar nerves (L2, 3), so a reproducible area of anesthesia can be obtained. This area of anesthesia consistently covered the mid line and had a predictable spread. our 1ry objective is to Measure the intra-operative excess fentanyl Consumption in Patients Undergoing Spine Surgery Under General Anesthesia with and without Thoracolumbar Interfascial Plane Block.our 2ry objectives are To evaluate the effect of ultrasound-guided Thoracolumbar Interfascial Plane Block in patients undergoing spine surgery under general anesthesia regarding Hemodynamics (Systolic BP,Diastolic BP,mean BP and HR ),Postoperative First Request of Analgesia,morphine consumption by PCA in the 1st 24 postoperative hours, and postoperative Pain Assessment by Numerical Rating Scale Score.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/09/2018
Actual trial start date 01/09/2018
Anticipated date of last follow up 01/03/2019
Actual Last follow-up date 02/03/2019
Anticipated target sample size (number of participants) 32
Actual target sample size (number of participants) 32
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group TLIP group 20 ml 0.25% Bupivacaine injection on each side once after induction of anesthesia patients will receive General Anesthesia as follows:Pre-Oxygenation and Induction with:Propofol 2mg/kg ,Atracurium 0.5mg/kg and Fentanyl 2 μg/kg.then Oral Endotracheal Intubation and Maintenance of Hypnosis with Inhalational Anesthesia (Isoflurane 1MAC) on O2 50%.patients will be given TLIP block by ultrasound guidance.20 ml 0.25% Bupivacaine will be injected after negative aspiration at the level of L3 lumbar spine in the fascial plane between the multifidus (MF) muscle and longissimus (LG) muscles.injection will be done on both sides. using an insulated 22G echogenic needle ,inserted In-Plane in a lateral to medial orientation through the belly of LG toward the MF. 0.5μg/kg IV-Fentanyl bolus dose will be given if the BP or HR increase by 20% from the baseline.- Patients will receive standardized IV patient-controlled analgesia (PCA) with morphine [0.5mg/ml morphine concentration, no background infusion, bolus 2mg, lock-out time 10minutes and 4hours limit of 20mg (maximum dose 5mg/hour)] through the first 24 hours post-operative. 16
Control Group control group 20 ml of normal saline injection on each side once after induction of anesthesia patients will receive General Anesthesia as follows:Pre-Oxygenation and Induction with:Propofol 2mg/kg ,Atracurium 0.5mg/kg and Fentanyl 2 μg/kg.then Oral Endotracheal Intubation and Maintenance of Hypnosis with Inhalational Anesthesia (Isoflurane 1MAC) on O2 50%.patients will be given 20 ml of normal saline that will be injected under ultrasound guidance after negative aspiration at the level of L3 lumbar spine in the fascial plane between the multifidus (MF) muscle and longissimus (LG) muscles.injection will be done on both sides. using an insulated 22G echogenic needle ,inserted In-Plane in a lateral to medial orientation through the belly of LG toward the MF. 0.5μg/kg IV-Fentanyl bolus dose will be given if the BP or HR increase by 20% from the baseline.- Patients will receive standardized IV patient-controlled analgesia (PCA) with morphine [0.5mg/ml morphine concentration, no background infusion, bolus 2mg, lock-out time 10minutes and 4hours limit of 20mg (maximum dose 5mg/hour)] through the first 24 hours post-operative. 16 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Elective Spine Surgery (Discectomy, Laminectomy and Fixation) under General Anesthesia. 2. American Society of Anesthesia Physiological Status (ASA) I to III. 3. Age from 21 to 70 years. 4. Both Genders. 5. BMI of 18-40 kg/m2. 1. Refusal of Participation to the Study. 2. American Society of Anesthesia Physiological Status (ASA) more than III. 3. Patients with Psychiatric Disease that would interfere with Perception and Assessment of pain. 4. Neurological or Neuromuscular Disease or Deficit. 5. Pregnant women. 6. Spine Deformities. 7. Allergy to Local Anesthetic. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 21 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
Yes 18/03/2018 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
kilo 4,5 ,ring road ,ismailia ,egypt ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intra-operative excess fentanyl Consumption through out surgery
Secondary Outcome Hemodynamics (Systolic BP,Diastolic BP,mean BP and HR ) and respiratory rate Baseline,10 minutes after Induction ,surgical incision,Intra-operative:every 15 mins,at Recovery,60 minutes after recovery,Postoperative:after 2, 4, 6 ,12,24 hours
Secondary Outcome postoperative First Request for anelgesia after recovery from anaesthesia
Secondary Outcome the first 24 hours post-operative morphine consumption the 1st postoperative 24 hours
Secondary Outcome postoperative Numerical Pain Rating score at rest and during 45-degree passive flexion of the Spine. after 2 ,4,6,12,24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
suez canal university hospital ring road kilo 4.5 ,ismailia ,egypt ismailia 41522 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university hospital kilo 4.5 ,ismailia ,egypt ismailia 41522 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Yassmin Ahmed Yussif Elgawish kilo 4.5 ,ring road ismailia 41522 Egypt
Ezzat Mohamed ElTaher kilo 4.5 ,ring road ismailia 41522 Egypt
Nihal Adel Nasr kilo 4.5 ,ring road ismailia 41522 Egypt
Mohamed Elsayed Ibrahim AbdelHamid kilo 4.5 ,ring road ismailia 41522 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yassmin Elgawish yassmin_elgawish@yahoo.com 00201007022488 kilo 4.5 ,ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt resident of anesthesia intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries Ezzat ElTaher ezzatme@gmail.com 00201007336217 kilo 4.5 ,ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt professor of anesthesia intensive care and pain management
Role Name Email Phone Street address
Public Enquiries Nihal Nasr nihalnasr.nn@gmail.com 00201001013124 kilo 4.5 ,ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia intensive care and pain management
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbdelHamid Mohamed_abuelnga@med.suez.edu.eg 00201004150671 kilo 4.5 ,ring road
City Postal code Country Position/Affiliation
ismailia 41522 Egypt lecturer of anesthesia intensive care and pain management
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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