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.: PACTR201809805202196 Date of Approval: 19/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Paravertebral Block versus Intercostal Nerve Block on The Nonintubated Video-Assisted Thoracoscopic Surgery.
Official scientific title Paravertebral Block versus Intercostal Nerve Block on The Nonintubated Video-Assisted Thoracoscopic Surgery.
Brief summary describing the background and objectives of the trial Nonintubated video-assisted thoracoscopic surgery (VATS) has been reported to be safe and feasible for patients with various thoracic diseases, including those who have respiratory dysfunction. We studied the sparing anesthetic and analgesic effects of either Paravertebral block or Intercostal nerve block on the nonintubated technique with spontaneous ventilation in patients under general anesthesia using a supraglottic airway device.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,intra and postoperative analgesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/06/2016
Actual trial start date 30/04/2018
Anticipated date of last follow up 30/04/2018
Actual Last follow-up date 30/04/2018
Anticipated target sample size (number of participants) 105
Actual target sample size (number of participants) 105
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I propofol 1.5-2 mg/kg IV, Fentanyl 1µ/kg IV and sevo¿urane 1-1.5 MAC 2 hours propofol 1.5-2 mg/kg IV, Fentanyl 1µ/kg IV and sevo¿urane 1-1.5 MAC 35 Active-Treatment of Control Group
Experimental Group Group II 15 ml solution of lidocaine 1% and 0.2% ropivacaine by single-shot paravertebral block before induction of the general anesthesia. 2 hours While the patient was in the sitting position with his feet rest on a stool to allow greater patient comfort and a greater degree of kyphosis. and under aseptic precautions 5 ml of lidocaine 1% is infiltrated subcutaneously along the line where the injections will be made. , At the level of T4 a needle epidural needle (Tuohy 18 G; Braun, Melsungen, Germany)is inserted 2.5¿3 cm lateral to the most 35
Experimental Group Group III After induction of the general anesthesia the surgeon performed thoracoscopic intercostal block infiltration mixture of lidocaine 1% and ropivacaine 0.2% to ensure fast onset of action and prolonged a 2 hours After induction of the general anesthesia the surgeon performed thoracoscopic intercostal block infiltration mixture of lidocaine 1% and ropivacaine 0.2% to ensure fast onset of action 35
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
105 patients aged 18-60 years, of either sex belonging to American Society of Anesthesiologists (ASA) physical status II-III unstable circulation, acute myocardial infarction, acute cerebral circulation disturbances, and coagulation disorders. Special contraindications for interventions under local anesthesia were significant encephalopathy and patient emotional instability. Patients who had any contraindication for epidural anesthesia, had preexisting motor and sensory deficit, patients with previous thoracic surgeries or known local anesthetic allergies were excluded from the study Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 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 01/06/2016 Tanta University. Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
EL BAHR St Tanta 31512 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome EFSevo, RR, Total amount of Fentanyl at the end of the surgery
Secondary Outcome BP, HR, SPO2, End-tidal carbon dioxide before induction of the GA, after induction of the GA, 20 minutes later, and immediately before the end of the surgery .
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University EL Bahr St Tanta Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
TANTA University EL Bahr St Tanta Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor TANTA UNIVERSITY EL Bahr St Tanta Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Mohamed Mogahed El Moatasem St Tanta Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona Mohamed Mogahed monamogahedfr@hotmail.com 01145130150 EL MOATASEM
City Postal code Country Position/Affiliation
TANTA Egypt Associate professor of Anesthesiology and surgical intensive care
Role Name Email Phone Street address
Public Enquiries Mohamed Elkahwagy m_elkahwagy2005@hotmail.com 0201205364252 Elsoltan Morad
City Postal code Country Position/Affiliation
Tanta Egypt lecturer of cardiothoracic surgery
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elkahwagy m_elkahwagy2005@hotmail.com 0201205364252 Elsoltan Morad
City Postal code Country Position/Affiliation
Tanta Egypt lecturer ofcardiothoraviv surgery
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