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.: PACTR202308910451816 Date of Approval: 24/08/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ropivacaine versus Bupivacaine in bilateral maxillary nerve block for cleft lip and palate surgery
Official scientific title Postoperative analgesic effects of Ropivacaine versus Bupivacaine in bilateral maxillary nerve block for cleft lip and palate surgery: a double-blind randomized controlled trial.
Brief summary describing the background and objectives of the trial Cleft lip and palate is one of the most common craniofacial anomalies in children. It requires early intervention to reduce its repercussions. However, its postoperative pain is considered significant, lasting from 24 to 48 hours. Managing this pain is a real challenge for the anesthetist. First-line analgesics are often insufficient, and the use of opioids is not risk free. In this context, locoregional analgesia has been gaining in popularity. Several studies have demonstrated the efficacy of maxillary nerve block in reducing postoperative pain in cleft lip and palate repair surgery, despite a short duration of efficacy. This is mainly due to the wide use of lidocaine. More recent studies have shown better results with bupivacaine . Recently, ropivacaine and levobupivacaine are tending to replace bupivacaine because of their lower cardiac toxicity. The established feasibility of maxillary blocking with these different molecules poses a problem of choice for the clinician. This choice must take into account safety, efficacy and cost, which seems to be higher with the new products. While cost is easy to analyze, efficacy requires high-quality comparative studies. The aim of this study is to compare the postoperative analgesic efficacy of Ropivacaine versus Bupivacaine in the maxillary block for cleft lip and palate surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 16/07/2023
Actual trial start date 01/08/2023
Anticipated date of last follow up 16/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Simple randomization using a randomization table created by a computer software program Numbered containers 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 Group Ropivacaine ropivacaine 0,2% (0,15 ml/kg) At the end of the surgery Patients of this group will have bilateral maxillary nerve block with ropivacaine 30
Control Group Group Bupivacaine bupivacaine 0.125 % ( 0.15 ml/kg ) At the end of the surgery Patients of this group will have bilateral maxillary nerve block with bupivacaine 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Parental consent • ASA I or ASA II • Age > 3 months • Primary cleft lip and palate surgery • Withdrawal from study participation • Intraoperative incident requiring intensive care unit hospitalization • Contraindication to maxillary block • Known allergy to used drugs Infant: 13 Month(s)-24 Month(s) 3 Month(s) 24 Month(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 12/06/2023 Ethics committee of the faculty of medecine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain - FLACC PAIN SCALE every 15 minutes during the first two hours, then, every 6 hours during the first 24 hours postoperatively
Secondary Outcome Parent’s satisfaction - likert scale 24 hours postoperatively
Secondary Outcome Nausea and vomiting during the first 24 hours postoperatively
Secondary Outcome Time to first oral liquid intake during the postoperative period
Secondary Outcome Postoperative analgesic requirments during the first 24 hours
Secondary Outcome Time to rescue analgesia Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul Teaching Hospital Route de la ceinture Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Sahloul Teaching Hospital Route de la ceinture Sahloul Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medecine of Sousse Rue Mohamed KAroui Sousse 4002 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Kahloul med.kahloul@outlook.fr +21623567317 Route de la ceinture
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medicine of Sousse
Role Name Email Phone Street address
Principal Investigator Yosra Snoussi yosrasnoussi@gmail.com +21650610196 Route de la ceinture
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Walid Naija walidnaija@yahoo.fr +21696162001 Route de la ceinture
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Public Enquiries Samia Ayachi samia.ayachi@gmail.com +21698322938 Route de la ceinture Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Scientific Enquiries Ajmi Chaouch ajmichaouch@yahoo.fr +21629848655 Route de la ceinture Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. It will include the entire individual participant data collected during the trial, after deidentification. The study protocol, the statistical analysis plan, the informed consent form and the clinical study report will also be available. All these documents will be shared with researchers who provide a methodologically sound proposal, for any purpose. Proposals should be directed to med.kahloul@outlook.fr. To gain access, data requestors will need to sign a data access agreement. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be shared during a 24-month period, beginning 9 months after article publication. Maxillary block , Ropivacaine , Bupivacaine, analgesia, cleft lip and palate
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