Cleft Lip Palate
Conditions
Keywords
Alveolar bone grafting, Quadratus lumborum block, Postoperative pain, Pediatric patients
Brief summary
This prospective, randomized, double-blinded controlled trial will investigate the effectiveness of a lateral quadratus lumborum (QL) block in 50 children aged 6-14 years undergoing iliac crest bone grafting for cleft alveolus repair. Participants will receive either a lateral QL block with bupivacaine and adrenaline or a sham skin puncture. The study will primarily assess postoperative pain at the iliac crest donor site. Secondary outcomes include pain during mobilization, pain at the alveolar surgical site, opioid consumption, time to first rescue analgesia, objective mobilization measured with activity monitors, time to hospital discharge, and adverse events. The study aims to determine whether QL block provides clinically relevant postoperative analgesia while facilitating earlier mobilization and potentially reducing hospital stay in this pediatric population.
Interventions
PROCEDURELateral quadratus lumborum block
A lateral QL blocks will be performed on the site of bone graft. An ultrasound system with a linear array transducer will be used for the QL block procedure. A sterile skin scrub will be performed before needle insertion. The ultrasound coated injection needle will be advanced until the needle tip is positioned between the aponeurosis of the transversus abdominis muscle and the pararenal fat close to the quadratus lumborum muscle. Following aspiration, 0.3 ml/kg of bupivacaine 2.5 mg/ml with adrenaline 5 mcg/ml will be injected.
PROCEDURESham Block
Only a skin puncture will be performed
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Children with cleft lip, palate and alveolus. * Scheduled for iliac crest bone grafting for cleft alveolus repair. * ASA physical status I-II. * Age from 6- 14 years old. * Written informed consent of the patients and their legal guardians
Exclusion criteria
* Allergy to local anaesthetics (e.g., bupivacaine) * Coagulation disorders or other contraindications to regional anaesthesia. * Neurological or developmental disorders that affect pain assessment or mobilization. * Skin infection at the QL injection site * Children and their parents who cannot speak or understand Norwegian * Any reason why, in the opinion of the investigators, the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative Pain at the Donor Site at Rest, Measured by VAS | From 2 hours to 48 hours after the surgical procedure |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative pain at the donor site while standing upright, Measured by VAS | 12 hours and 24 hours after the surgical procedure |
| Postoperative Pain at the the recipient surgical site (alveolus), Measured by VAS | From 2 hours to 48 hours after the surgical procedure |
| Time to first analgesic request, Measured in hours | From 0 hours to 48 hours after the surgical procedure |
| Cumulative opioid consumption at 24 hours | From 0 hours to 24 hours after the surgical intervention |
| Number of steps measured with a motion monitor during the first 24 hours | From 0 hours to 24 hours after the surgical intervention |
| Time spent upright during the first 24 hours | From 0 hours to 24 hours after the surgical intervention |
| The time (in hours) from surgery to discharge from the hospital | From 0 hours after the surgical procedure until discharge from hospital |
| Side effects and adverse events | From Anaesthesia induction until 48 hours after the surgical procedure |
Countries
Norway
Contacts
CONTACTAxel R Sauter, MD, PhD
CONTACTNina N Suleiman, MD
Outcome results
None listed