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.: PACTR202008762159889 Date of Approval: 24/08/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Local anaesthesia for medical thoracoscopy
Official scientific title Randomised controlled trial of intra-Cavitary Anaesthesia for Medical thoracoscopy to improve procedural Pain (the CAMP trial)
Brief summary describing the background and objectives of the trial Medical thoracoscopy (MT) has a major role in the management pathway of undiagnosed exudative pleural effusions with a diagnostic sensitivity of more than 90%. In addition, for cases that require pleurodesis, it can act as a means of delivering the pleurodesing substance thus combining a diagnostic and a therapeutic role. For the purpose of performing a pleural biopsy or pleurodesis, a single-port procedure is typically carried out. The procedure is usually carried out by a respiratory physician on a spontaneously breathing patient under conscious sedation. The majority of centres in Europe and the US use a combination of a benzodiazepine and an opiate for analgosedation but some centres use propofol instead of the benzodiazepine to benefit from the deeper sedation with the latter. The procedure is generally tolerated but some patients suffer from considerable pain during pleural biopsy or pleurodesis and occasionally the procedure has to be aborted and rescheduled under general anaesthesia due to considerable patient discomfort. Intrapleural blockade, a technique that involves injecting an anaesthetic substance into the thoracic cage between the parietal and visceral pleura to produce ipsilateral somatic block of multiple thoracic dermatomes, has been described more than two decades ago as a potent option to control postoperative pain.8 This technique is effective in treating unilateral surgical and nonsurgical pain from the chest and upper abdomen in both the acute and chronic settings. A recent open label pilot study has shown the safety of using intrapleural lidocaine as the main analgesic during MT with acceptable patient tolerability. This randomised controlled trial aims to establish whether intrapleural lidocaine leads to lower patient rated pain during MT and whether this could be achieved with lower doses of intravenous analgo-sedation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CAMP
Disease(s) or condition(s) being studied Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 15/08/2020
Actual trial start date
Anticipated date of last follow up 15/06/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 34
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 Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intrpleural anaesthesia 3 mg/kg lidocaine up to maximum 200 mg lidocaine One off Local (intra-cavitary) anaesthesia 17
Control Group Control arm 20 ml normal saline One off Placebo intrapleural anaesthesia 17 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Adult - Requiring medical thoracoscopy - Willing to provide consent - Complex septated pleural effusion - Pneumothorax induction required prior to procedure - Substantial chest pain that would interfere with assessing study intervention effect 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 99 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 21/05/2020 Alexandria Faculty of Medicine Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine Alexandria University, 17 Champlion Street, El-Messalah, Alexandria, Egypt Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome patient-rated procedural pain as measured by 100 mm visual analogue scale (VAS) score for pain at the end of the procedure Within 20 minutes of the end of procedure
Secondary Outcome practitioner- rated procedural pain as measured by 100 mm VAS score for pain At the end of the procedure
Secondary Outcome patient- rated pain score 2 hours post procedure 2 hours post procedure
Secondary Outcome patient experience as measured by likelihood procedure (on a 100 mm VAS) of having repeated if indicated 2 hours post procedure
Secondary Outcome difference in sedative doses required peri-procedure Post procedure
Secondary Outcome difference in rates of procedure-related complications 2 hours post procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Chest Diseases Department at Alexandria Faculty of Medicine Khartoum Square, Azarita Alexandria 21521 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria University Hospitals Koleyet El teb Street Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria University Faculty of Medicine 17 Champlion Street, Messalah Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed Gadallah Faculty of Medicine, Khartoum Square Alexandria Egypt
Prof Sahar Murad Faculty of Medicine, Khartoum Square Alexandria Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maged Hassan maged.mahmoud@alexmed.edu.eg +201289549083 Faculty of Medicine, Khartoum Square
City Postal code Country Position/Affiliation
Alexandria Egypt Chest Diseases Department at Alexandria University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Maged Hassan maged.mahmoud@alexmed.edy.eg +201289549083 85 Tiba Street
City Postal code Country Position/Affiliation
Alexandria Egypt Alexandria Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Maged Hassan maged.mahmoud@alexmed.edu.eg +201289549083 85 Tiba Street
City Postal code Country Position/Affiliation
Alexandria Egypt Alexandria Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Spreadsheets with (anonymized) individual patient-level data will be stored electronically for a minimum period of five years after trial completion. This data will available for use in further research by the trial team or, upon request, by individuals/teams outside the trial team. Five years after trial completion Researchers requiring access will contact trial staff electronically (via email) and after review request, access will be granted if deemed appropriate by trial team.
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 - 21/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information