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.: PACTR201805003410305 Date of Approval: 23/05/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided paravertebral block versus intravenous lidocaine infusion for management of post-thoracotomy pain
Official scientific title Ultrasound guided paravertebral block versus intravenous lidocaine infusion for management of post-thoracotomy pain
Brief summary describing the background and objectives of the trial Objectives: to compare the analgesic effects of paravertebral block versus lidocaine infusion for management of post-thoracotomy pain. Methods: Sixty patients were randomly divided into two equal groups; IV group received 1.5 mg/kg of 1% lidocaine over 10 minutes then infusion of 1.5 mg/kg/hr., and paravertebral group (PVB) received 10 ml lidocaine 1% over 30 secs then infusion of 1.5 mg/kg/hr through catheter inserted under ultrasound guidance. Hemodynamic and respiratory variables, frequency and duration of postoperative mechanical ventilation, duration of ICU stay, time till start of respiratory exercise and till chest tube removal, Analgesia was assessed using 100-point visual analogue scale and defined as VAS <30 mm at rest, and in case of inadequate analgesia, IV morphine 2 mg was given. Frequency of complications and postoperative hospital stay were also recorded Results: 17 patients maintained on MV for mean duration of 1.5±0.5 days. PVB group was successfully weaned from MV and extubated after significantly shorter duration. Mean duration of ICU stay, time till start of respiratory exercise and till removal of chest tube were significantly shorter in PVB group. All patients requested analgesia, but the frequency of consumption and mean number of requests were significantly higher in IV group. VAS scores determined at 1-, 2-, 12-, 36-hr and cumulative 48-hr VAS scores were significantly lower in PVB group compared to IV group. Conclusion: Ultrasound guidance allowed safe paravertebral space catheterization. PVB using continuous lidocaine infusion provided adequate analgesia for post-thoracotomy pain with significant reduction of rescue analgesia, shorter time till respiratory exercises start, minimal complications and shorter hospital stay
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Respiratory,Surgery,Ultrasound guided paravertebral block versus intravenous lidocaine infusion
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/01/2018
Actual trial start date 05/01/2018
Anticipated date of last follow up 27/04/2018
Actual Last follow-up date 30/04/2018
Anticipated target sample size (number of participants) 64
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation 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 IV Group Intravenous lidocaine 1%, in a dose of 1.5 mg/kg as initial dose over 10 minutes then as continuous infusion of 1.5 mg/kg/hr. 24 hours patients assigned to receive postoperative (PO) analgesia in the form of intravenous lidocaine 1%, in a dose of 1.5 mg/kg as initial dose over 10 minutes then as continuous infusion of 1.5 mg/kg/hr. 30 Active-Treatment of Control Group
Experimental Group PVB group 10 ml of 1% lidocaine over 30 secs then continuous PVB using lidocaine 1% infusion at the rate of 1.5 mg/kg/hr through catheter in 24 hours patients assigned to received post-operative analgesia in the form of 10 ml of 1% lidocaine over 30 secs then continuous PVB using lidocaine 1% infusion at the rate of 1.5 mg/kg/hr through catheter inserted in the paravertebral space (PVS) under ultrasound guidance. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. American Society of Anesthesiologists (ASA) status I to III adults 2. Age of patients from 36 to 66 years 3. Sex all genders 4. Patients scheduled for thoracotomy 5.BMI range: 24.4-34.2 Kg/m2 4-all the procedures were performed by the same team of anesthetists and surgeons. 1-Patients with systemic diseases, such as diabetes mellitus, hypertension, renal or hepatic dysfunction, 2-bleeding diathesis, 3-neurological diseases, 4-hypersensitivity to the used drugs were excluded Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 36 Year(s) 66 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 06/06/2016 Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy Cairo 11451 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adequacy of analgesia patients were asked to rate their pain at rest every hour for 3 hours and then at 12-, 24-, 36- and 48-hr PO. Adequate analgesia was defined as a VAS <30 mm at rest and inadequate analgesia was defined as VAS at rest >30 mm despite the adjusted rate of infusions.
Secondary Outcome Hemodynamic measures Hemodynamic measures including heart rate (HR), mean arterial blood pressure (MAP), end of the 1st 24-hr PO and expressed collectively at end of 24-hr.
Secondary Outcome Need for mechanical ventilation (MV) and its duration, duration Immediate PO data including the frequency of need for mechanical ventilation (MV) and its duration, duration of ICU stay, time till start of respiratory exercise and time till removal of chest drainage tube.
Secondary Outcome Complications Frequency of complications including nausea and vomiting, urinary retention, respiratory depression, needle insertionsite infection, sedation and total PO hospital stay were recorded [Time Frame: 48 hours]
Secondary Outcome Respiratory measures Respiratory measures including respiratory rate and partial arterial oxygen saturation were determined every hour for 3-hr and 3-hourly till the end of the 1st 24-hr PO and expressed collectively at end of 24-hr.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr Alainy Hospitals Kasr Alainy Cairo 11451 Egypt
National Cancer Institute Kasr Alainy Cairo 11451 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University Hospitals Kasr Alainy Cairo 11451 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Cairo 11451 Egypt University
Secondary Sponsor National Cancer Institute Kasr Alainy Cairo 11451 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Abdalla AL Ahram Cairo 11451 Egypt
Wael Ahmed Ibrahim AL Ahram Cairo 11451 Egypt
Tamer Fayez Safan Dokki Cairo 11451 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abdalla ahmed.aboali7268@gmail.com 00201272222923 AL Ahram
City Postal code Country Position/Affiliation
Cairo 11451 Egypt Associated professor of anaesthesia, faculty of medicine, Cairo University. Cairo, Egypt
Role Name Email Phone Street address
Public Enquiries Ahmed Abdalla waelahmed60@hotmail.com 00201222857972 AL Ahram
City Postal code Country Position/Affiliation
Cairo 11451 Egypt Associated professor of anaesthesia&, National Cancer Institute, Cairo University
Role Name Email Phone Street address
Scientific Enquiries Tamer Safan safan.tamer@hotmail.com 00201223339850 Dokki
City Postal code Country Position/Affiliation
Cairo 11451 Egypt Lecturer of anesthesia, faculty of medicine, Cairo University.
REPORTING
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