Cleft Lip PalateNCT07846761
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
A study testing Lateral quadratus lumborum block in people with Cleft Lip Palate, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cleft Lip Palate
- What is being tested?
- Lateral quadratus lumborum block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2026to 1 Mar 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
Oslo University Hospital
Oslo, 0372
Axel R Sauter, MD, PhD, 23070000, axsa@online.no
About this study
Official title: Effectiveness of Quadratus Lumborum Block in Reducing Postoperative Pain, Enhancing Mobilization, and Shortening Hospital Stay in Children Undergoing Iliac Bone Harvest for Cleft Alveolus Repair- a Prospective Randomized Controlled Study
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.
- Conditions
- Cleft Lip Palate
- Being tested
- Lateral quadratus lumborum block, Sham Block
- Keywords
- Alveolar bone grafting, Quadratus lumborum block, Postoperative pain, Pediatric patients
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral quadratus lumborum blockProcedure or surgery
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.
Sham BlockProcedure or surgery
Only a skin puncture will be performed
| Study group | Role | What they receive |
|---|---|---|
| Quadratus lumborum block | Active comparator | Not described Receives: Procedure: Lateral quadratus lumborum block |
| Sham treatment (skin puncture) | Sham comparator | Not described Receives: Procedure: Sham Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain at the Donor Site at Rest, Measured by VAS
Measured: From 2 hours to 48 hours after the surgical procedure
Secondary outcomes (8)
Postoperative pain at the donor site while standing upright, Measured by VAS
Measured: 12 hours and 24 hours after the surgical procedure
Postoperative Pain at the the recipient surgical site (alveolus), Measured by VAS
Measured: From 2 hours to 48 hours after the surgical procedure
Time to first analgesic request, Measured in hours
Measured: From 0 hours to 48 hours after the surgical procedure
Cumulative opioid consumption at 24 hours
Measured: From 0 hours to 24 hours after the surgical intervention
Number of steps measured with a motion monitor during the first 24 hours
Measured: From 0 hours to 24 hours after the surgical intervention
Time spent upright during the first 24 hours
Measured: From 0 hours to 24 hours after the surgical intervention
The time (in hours) from surgery to discharge from the hospital
Measured: From 0 hours after the surgical procedure until discharge from hospital
Side effects and adverse events
Measured: From Anaesthesia induction until 48 hours after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip PalateStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Rudolf Sauter, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846761
- Sponsor's protocol ID
- 981783
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided