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.: PACTR202206745131592 Date of Approval: 28/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The impact of intraoperative intravenous lidocaine infusion on early postoperative pain after complex spine surgery
Official scientific title The impact of intraoperative intravenous lidocaine infusion on early postoperative pain after complex spine surgery
Brief summary describing the background and objectives of the trial It is known that complex spinal surgeries are associated with severe postoperative pain which has a great effect on postoperative recovery. In our study we will try the effect of intraoperative intravenous lidocaine infusion in patients who will undergo complex spinal surgeries on early postoperative pain and quality of recovery.
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: Drugs
Anticipated trial start date 05/09/2021
Actual trial start date
Anticipated date of last follow up 05/05/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 90
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
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lidocaine infusion lidocaine group will receive a loading dose of lidocaine of 1 mg/kg with induction of anesthesia then lidocaine infusion will be started at dose of 1.5 mg/kg/hr (1.5 ml for each 10kg) till the end of procedure. After induction of anesthesia till before extubation 25ml of lidocaine 2% (500 mg) will be added to 25 ml 0.9 normal saline so each ml in syringe will contain l0 mg of the drug lidocaine group will receive a loading dose of lidocaine of 1 mg/kg with induction of anesthesia then lidocaine infusion will be started at dose of 1.5 mg/kg/hr (1.5 ml for each 10kg) till the end of procedure. Patients in this group will be kept in PACU under monitoring for two hours postoperative to monitor signs of lidocaine toxicity (circumoral numbness, hypotension and arrhythmia 45
Control Group Placebo group Placebo group will receive 0.9 normal saline in a way like experimental group. After induction of anesthesia till before extubation Placebo group will receive 0.9 normal saline in a way like experimental group. 45 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. All patients who will undergo complex spinal surgery with ASA score III or less. 2. Age group 21 -60 years old of both sexes. 1. Patients younger than 21 years old or more than 60 years old. 2. Patients with ASA score IV or more. 3. Patients with lower limb weakness (bromage score 2 or more). 4. Patients with allergy to local anesthetics. 5. Patients with chronic renal failure. 6. Patients with hepatic disease. 7. Patients with morbid obesity BMI 40 or more.. 8. Patients with history of drug abuse. 9. Patients who will receive analgesics 24 hours preoperative. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 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 24/08/2021 ethical commite at ain shams university
Ethics Committee Address
Street address City Postal code Country
38 abbasia next to elnour mosque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome is to assess the postoperative rescue analgesic consumption the total dose needed in the first 24 hrs and the time needed for the first request The first 24 hrs postoperative
Secondary Outcome Early postoperative pain by the visual analog scale VAS 30 minutes, 4 hours, 8 hours, 12 hours and 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of medicine Ain Shams University 38 Abbassia Square, Next to Al-Nour Mosque, Cairo,Egypt Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Eslam reda abd elhay Faculty of medicine ain shams university cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine ain shams university 38 abbsaia cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
eslam reda abdelhay 66 mohamed elnady st,nasr city cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Eslam ABDELHAY eslamr1888@gmail.com 01221534104 66 mohamed el nady st, naser city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant lecturer anesthesia department faculty of medicine ain shams university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Fawaz aafawaz@hotmail.com +201001409220 El nakheil compound first settlement,villa 416
City Postal code Country Position/Affiliation
Cairo Egypt Professor of anesthesia faculty of medicine Ain shams university
Role Name Email Phone Street address
Principal Investigator Tamer Nabil tamernabil610@gmail.com +201288992910 Diar 1 compound gamal abdelnaser road ,6th October city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer at anesthesia department faculty of medicine ain shams university
Role Name Email Phone Street address
Scientific Enquiries Sameh Salem drsamehtaha@med.asu.edu.eg +201001587903 37 shaheen Street,ain shams
City Postal code Country Position/Affiliation
Cairo Egypt Assistant professor at anesthesia department faculty of medicine ain shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data will be available Study Protocol not applicable not applicable
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