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.: PACTR202002562789051 Date of Approval: 13/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Modified thoracolumbar interfascial plane block for analgesia in spine surgery
Official scientific title Efficacy of ultrasound-guided modified thoracolumbar interfascial plane block for acute pain management in lumbar laminectomy.
Brief summary describing the background and objectives of the trial In spine surgery, adequate pain relief perioperative is important for the patient's early mobilization and uneventful postoperative course. these patients are already suffering from chronic pain. There is a modification of Thoracolumbar interfascial plane block technique by injecting local anesthetic between the longissimus and iliocostalis muscles.The modified method has several advantages. 1. Advancing the needle from a medial to lateral direction eliminates the risk of possible inadvertent neuraxial injection. 2. Injecting between the iliocostalis and longissimus muscles results in a dermatomal area of analgesia similar to that obtained with an injection made between the multifidus and longissimus muscles. The distribution of the local anesthetics spread two levels caudal and cranial to the injection site. 3. Sonographic imaging more easily identifies the distinction between the longissimus and iliocostalis muscles than between the multifidus and longissimus muscles, thereby potentially increasing the success rate of the block. The aim of our study is to investigate the efficacy of the modified TLIP block for acute pain management in lumbar laminectomy surgeries
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 acute pain management
Anticipated trial start date 01/02/2020
Actual trial start date
Anticipated date of last follow up 01/08/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status 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
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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anesthesia and sham block induction of general anesthesia by fentanyl 1 µg/kg, atracurium 0.5 mg/kg, propofol 2 mg/kg, and dexamethasone 8 maintenance by sevoflurane and atracurium 0.1mg/kg fentanyl (1µg/kg) when heart rate or mean blood pressure increased more than 25% above the baseline intraoperative period Induction Will be performed using fentanyl 1 µg/kg, atracurium 0.5 mg/kg, propofol 2 mg/kg, and dexamethasone 8 mg. Intubation will be done by an armored endotracheal tube of appropriate size. Anesthesia will be maintained with sevoflurane (variable concentration to maintain BIS between 40-60) atracurium 0.1mg/kg as required and ventilator settings will be adjusted to keep EtCO2 between 35 and 40 mmHg. The patient will be turned to the prone position carefully with careful padding of pressure points and eyes. Intraoperative analgesia will be provided by supplementary doses of intravenous fentanyl (1µg/kg) when heart rate or mean blood pressure increased more than 25% above the baseline. At the end of surgery, sevoflurane will be discontinued, and muscle relaxant will be reversed. Careful tracheal extubation will be performed after fulfilling the criteria for extubation. 20 Placebo
Experimental Group general anesthesia and modified thoracolumbar interfascial plane block bilateral single shot 20 ml 0.25% bupivacaine single shot preoperative Under aseptic technique and after infiltration with 5 ml of 1% lidocaine, a 22G, 10-cm, insulated echogenic needle (visioplex® - vygon – France) will be introduced in an in- plane approach, a medial to lateral direction through the belly of longissimus muscle toward the iliocostalis muscle. Injection of local anesthetic will be in the fascial plane between longissimus and iliocostalis muscles. After 30 minutes, loss of cold sensation will be done to evaluate spread of dermatomal loss of sensation. Failure of block will be considered if loss of sensation will not be attained within 30 minutes. 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Fourty patients, aged 20-60 years both sex, ASA physical status I or II, patients scheduled for elective single level lumbar laminectomy under general anesthesia. Patient's refusal, obesity (BMI > 35 kg/m2), infection at the site of the needle puncture, allergy to any of the study drugs, coagulopathy, and uncooperative patients or who can't express pain via visual analogue scale (VAS). Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 21/01/2020 Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Elgeish St Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time until the first request of rescue analgesia which indicated duration of analgesia. from end of TLIP block till first request of analgesia postoperative
Secondary Outcome Total fentanyl consumption. Intraoperative
Secondary Outcome heart rate and mean arterial blood pressure baseline, 5 ,10,15 min after the block, and immediately after intubation then every 15 min till the end of surgery.
Secondary Outcome Total morphine consumption first 24 h postoperative
Secondary Outcome visual analogue scale at PACU arrival then after 1, 2, 4, 6, 8, 12, 18 and 24 h postoperative
Secondary Outcome complications first 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Facualty of Medicine Elgeish st Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Mohammad Ali Abduallah Elgeish st Tanta 31527 Egypt
Mona Raafat Elghamry Elgeish st Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammad abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Scientific Enquiries Mohammad Abduallah Moh_aly_2005@hotmail.com +201099957971 Elgeish St
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor
Role Name Email Phone Street address
Public Enquiries Mona Raafat drmonagh19802000@gmail.com +201060101867 Elgeish st
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age ,sex,BMI, duration of surgery intraoperative and postoperative opioid consumption,pain score, time of first analgesic request, complications Statistical Analysis Plan IPD will be shared after finishing and publication of the study and it will be available for 1 year. the IPD will be available for scientific research only up on e-mail request. request will be sent to e-mail of one of the authors (drmonagh19802000@gmail.com)
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