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.: PACTR202103785412583 Date of Approval: 17/03/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Lidocaine with ketamine in posterior spine fusion
Official scientific title Intravenous lidocaine infusion with single low-dose ketamine as an adjuvant to general anesthesia in posterior spine fusion
Brief summary describing the background and objectives of the trial Pain relief after posterior spine fusion is a challenging problem among anesthesiologists. Numerous techniques were tried to control postoperative pain which depends mainly on adding opioids either via intravenous, intrathecal, or epidural routes. 60 adult patients aged between 18 - 65 years old, undergoing elective two or more levels of lumbar posterior spine fusion under general anesthesia were enrolled in this study. Patients were randomly allocated, using a computer-generated random table, into either the Narcotic group (N-group) or Lidocaine / Ketamine group (LK- group) with a 1:1 allocation ratio (30 patients in each group). The primary outcome measures were total intraoperative and postoperative opioid consumption and NPS during the first 24hr. postoperatively. The secondary outcome measures were sedation score, i.v. rescue analgesia, PONV, and pruritis during the first 24hr. postoperatively. The sample size was calculated using PASS 11.0 and based on a study carried out by Jendoubi et al., 2017; [19] Group sample sizes of 30 patients in group I (Lidocaine/ketamine) and 30 patients in Group II (Narcotic only) achieve 88% power to detect a difference of -15.6 between the null hypothesis that both groups means are 32.0 and the alternative hypothesis that the mean of group 2 is 47.6 with estimated group standard deviations of 7.0 and 5.0 and with a significance level (alpha) of 0.05000 using a two-sided two-sample t-test.
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 Prevention
Anticipated trial start date 20/03/2021
Actual trial start date 20/03/2021
Anticipated date of last follow up 20/06/2021
Actual Last follow-up date 15/11/2021
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
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
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
Experimental Group LK Group A bolus dose of i.v. lidocaine (1.5mg/kg) together with low dose i.v. ketamine (0.25 mg/kg) will be given during general anesthesia induction, followed by continuous i.v. lidocaine infusion via a syringe pump at a rate of 1.5mg/kg/h. after tracheal intubation. - The lidocaine infusion will be maintained throughout the surgery and stopped at the end of the surgery. - Single low dose ketamine will be given during general anesthesia induction. In the LK group, General anesthesia will be intravenously induced using 2µg/kg of fentanyl, 2mg/kg of propofol, and 0.5mg/kg of atracurium. An appropriate size endotracheal tube will be then inserted and secured. Controlled mechanical ventilation will be adjusted using Aisys Carestation TM (GE Healthcare, Madison, WI, USA) to keep end-tidal CO2 between 35 – 40 mmHg. Maintenance of anesthesia will be done using 1 MAC inhalational sevoflurane. Ondansetron 4 mg i.v. will be given as prophylaxis against postoperative nausea and vomiting (PONV). Intraoperative hemodynamic stability will be achieved by titrating inhalational inspired gas concentration with intermittent i.v. fentanyl boluses keeping HR and MAP within 20% baseline. A bolus dose of i.v. lidocaine (1.5mg/kg) together with single low dose i.v. ketamine (0.25 mg/kg) will be given during anesthesia induction, followed by continuous i.v. lidocaine infusion via a syringe pump (Injectomat Agilia®; Fresenius Kabi, Homburg, Germany) at a rate of 1.5mg/kg/h. after tracheal intubation. Another i.v. access will be inserted and secured for lidocaine infusion. The infusion will be maintained throughout the surgery and stopped at the end of the surgery. 30
Control Group N Group - A bolus dose of i.v. 0.9% saline (equal to the bolus dose of i.v. lidocaine given in the LK group) will be given during general anesthesia induction followed by continuous i.v. 0.9% saline infusion via a syringe pump. - A single dose of i.v. 0.9% saline (equal to the single dose of ketamine given in the LK group) will be given during general anesthesia induction. The saline infusion will be maintained throughout the surgery and stopped at the end of the surgery. General anesthesia will be intravenously induced using 2µg/kg of fentanyl, 2mg/kg of propofol, and 0.5mg/kg of atracurium. An appropriate size endotracheal tube will be then inserted and secured. An equal volume of 0.9% saline will be administered instead of lidocaine and ketamine (placebo). Controlled mechanical ventilation will be adjusted using Aisys Carestation TM (GE Healthcare, Madison, WI, USA) to keep end-tidal CO2 between 35 – 40 mmHg. Maintenance of anesthesia will be done using 1 MAC inhalational sevoflurane. Ondansetron 4 mg i.v. will be given to all patients as prophylaxis against postoperative nausea and vomiting (PONV). Intraoperative hemodynamic stability will be achieved by titrating inhalational inspired gas concentration with intermittent i.v. fentanyl boluses keeping HR and MAP within 20% baseline. An equal volume of 0.9% saline will be administered instead of lidocaine and ketamine (placebo). 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
60 adult patients aged between 18 - 65 years old, undergoing elective two or more levels of lumbar posterior spine fusion under general anesthesia will be enrolled in this study. Inclusion criteria include patients of both genders with American Society of Anesthesiologists (ASA) physical status I/II. Known hypersensitivity to lidocaine or ketamine, pregnancy, severe renal disorder, hepatic dysfunction, cardiac arrhythmias, severe cardiac or pulmonary disease, increased intraocular pressure, history of psychiatric disorders, epilepsy, history of alcohol or drug abuse, patients receiving beta-blockers or antiarrhythmics, uncontrolled diabetes or hypertension, and patients unable to operate patient-controlled analgesia (PCA) pump. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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
No 18/03/2021 Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Ramses street , Abassia, Cairo 11566 Egypt
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 08/04/2021 Ain Shams University Faculty of Medicine Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ramsis Street Cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The total intraoperative and postoperative opioid consumption and numeric pain scale. During the first 24hr. postoperatively.
Secondary Outcome Sedation score, i.v. rescue analgesic, PONV and pruritis. During the first 24hr. postoperatively.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams educational hospitals Ramses street , Abassia Cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ain Shams University Ramsis street, Abassia Cairo 11566 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Mansour Hussein Ramses street, Abassia Cairo 11566 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed M Elhennawy Ramses street, Abassia Cairo 11566 Egypt
Mostafa Mansour Hussein Ramses street, Abassia Cairo 11566 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Ramses street, Abassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care faculty of medicine Ain Shams university
Role Name Email Phone Street address
Public Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Ramses street, Abassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care Faculty of medicine Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Mostafa Mansour Houssein mostafa_mansour361@hotmail.com 00201093322145 Ramses street, Abassia
City Postal code Country Position/Affiliation
Cairo 11566 Egypt Assistant professor of anesthesia and intensive care Faculty of medicine Ain Shams university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data (IPD) for this trial is not available (including data dictionaries) No/undecided IPD sharing Informed Consent Form,Statistical Analysis Plan,Study Protocol 1 year individual participant data (IPD) for this trial is not available (including data dictionaries) No/undecided IPD sharing
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