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.: PACTR201512001341395 Date of Registration: 06/11/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ultrasound guided paravertebral block for thoracoscopy
Official scientific title Ultrasound guided paravertebral block versus local anesthesia for video assisted thoracoscopy .
Brief summary describing the background and objectives of the trial Video-assisted thoracoscopic (VAT) surgery is finding an ever-increasing role in the diagnosis and treatment of a wide range of thoracic disorders that previously required sternotomy or open thoracotomy. The potential advantages of VAT surgery include less postoperative pain, fewer operative complications, shortened hospital stay and reduced costs . Paravertebral Block (PVB) has the potential to offer long-lasting pain relief because it can uniquely eliminate cortical responses to thoracic dermatomal stimulation . PVB has been used for postoperative analgesia as well as sole anesthetic.The proximity of the paravertebral space to the lung leads to a risk of pneumothorax (0%¿6.7%) . Ultrasound-guided (USG) thoracic PVB offers several potential advantages over landmark-based techniques. In this study a comparison will be made between USG-PVB unilaterally at different numbers of thoracic levels and also between them and wound infiltration for thoracoscopic procedures. With the hypothesis that; three-level PVB will provide better analgesia and patient satisfaction than the two-level PVB; whereas the two-level PVB will provide superior analgesia over wound infiltration. We assumed also that better pulmonary outcome will follow PVB than wound infiltration. Objectives: A method of regional anesthesia for those patients with less risk and better pain relief intraoperatively and during the postoperative period and more patient satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,thoracic dermatomal stimulation
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/12/2014
Actual trial start date 21/12/2014
Anticipated date of last follow up 02/11/2015
Actual Last follow-up date 02/11/2015
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
protocol number R110 local ethical committee /Mansoura faculty of medicicne
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a sealed envelops Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Wound infiltration 4ml of bupivacaine 0.5% plus 4 ml mepivacine 2% in a total volume 8 ml at the puncture site before the procedure for around ninety minutes Patients in WI group will receive local infiltration with 4ml of bupivacaine 0.5% plus 4 ml mepivacine 2% in a total volume 8 ml at the puncture site and inside the pleural cavity after penetration with the rigid thoracoscopy. 15 Active-Treatment of Control Group
Experimental Group Two level ultrasound guided paravertebral block group 9 ml bupivacaine 0.5% plus 2 mg/kg of mepivacine 2% in a total volume 18 ml around ninety minutes 2 level paravertebral block using ultrasound to visualise the needle in the paravertebral space with confirmation After negative aspiration for blood and confirmation of needle position in the paravertebral space , 9 ml of the anesthetic prepared will be injected in each space in 2-level PVB group . 15 Active-Treatment of Control Group
Experimental Group Three level ultrasound guided paravertebral block group 9 ml bupivacaine 0.5% plus 2 mg/kg of mepivacine 2% in a total volume 18 ml with a volume of six ml given in each level around 90 minutes 3 level paravertebral block using ultrasound to visualise the needle in the paravertebral space with confirmation After negative aspiration for blood and confirmation of needle position in the paravertebral space , six ml of the anesthetic prepared will be injected in each space in 3-level PVB group . 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients ASA I and II status. 2. Patients who will elective unilateral rigid medical thoracoscopy for diagnosis and management of a variety of pleural diseases. 3. The age group is above 18 years old . 1. refusal to share. 2. Coagulopathy. 3. Infection at the needle entry site. 4. Allergy to local anesthetics . 5. patients on current opioid prescription or had previous thoracotomy . 6. Patients with significant concurrent medical disease, empyema, chest deformity 7. Patients with sensory deficit 18 Year(s) 70 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 01/10/2014 Local Ethical committee Mansoura faculty of medicine
Ethics Committee Address
Street address City Postal code Country
Elgmhoria street Elmansourah 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome intraoperative and postoperative analgesia using VAS Immediate postoperative 1 hour after thoracoscopy 6 hours afterthoracoscopy 12 hours after thoracoscopy
Secondary Outcome Peak Expiratory flow rate( indicator of pulmonary function) 1hour after thoracoscope 6hours after thoracoscope 12hours after thoracoscope 24 hours after thoracoscope
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chest Department , Mansourah university hospital , Mansourah university . Elgmhoria street Elmansourah 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University hospitals Elgmhoria street Elmansourah 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura University hospitals Elgmhoria street Elmansourah 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Maha A. Abo-Zeid Elgmhoria street Elmansourah 35516 Egypt
Asem A. Hewidy Elgmhoria street Elmansourah 35516 Egypt
Mohamed Maher El Gamal Elgmhoria street Elmansourah 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator MAHA ABO-ZEID mahazed@yahoo.com 0020114226976 Elgomhoria street, Anesthesia department,mansoura university hospitals000.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Alaa Elmaadawy a_maadawy@hotmail.com 0020113304999 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries MAHA ABO-ZEID mahazed@yahoo.com 0020114226976 Elgomhoria street, Anesthesia department,mansoura university hospitals.
City Postal code Country Position/Affiliation
Elmansoura 35516 Egypt Lecturer
REPORTING
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