The effect of bilateral ultrasound-guided maxillary nerve block on pain relief following cleft palate repair surgery

Bilateral maxillary nerve blocks via a suprazygomatic approach to the pterygopalatine fossa for pain relief in cleft palate repairs: a comparative study of general anaesthesia combined with bilateral maxillary nerve blocks via a suprazygomatic approach to the pterygopalatine fossa with 0.25% levobupivacaine, versus general anaesthesia alone on pain management in cleft palate repairs

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10977452

Enrollment

100

Registered

2019-07-18

Start date

2019-07-01

Completion date

Unknown

Last updated

2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft palate repair pain management Signs and Symptoms

Interventions

The researchers will be retrospectively recording data on primary and secondary outcomes in a group who underwent general anaesthetic and local anaesthetic and those who just had general anaesthetic i

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. All cleft palate primary repairs +/- lip repairs 2. Secondary cleft palate repairs +/- lip repairs

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 04/05/2021: 1. Solo cleft lip repairs _____ Previous exclusion criteria: 1. Local anaesthetic allergy 2. Bleeding disorders 3. Cutaneous infection 4. Solo cleft lip repairs

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 04/05/2021: Opioid consumption up to 48 h postoperatively _____ Previous primary outcome measure: Postoperative opiate consumption at 48 hours and to discharge, measured from patients' medical records	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 04/05/2021: Measured from patients' medical records: 1. Time to first analgesic requirement 2. Time to discharge from recovery and hospital 3. Block problems 4. Airway complications 5. Postoperative nausea and vomiting Other data collected: 6. Type of general anaesthetic 7. Surgical infiltration 8. Unplanned admission to ICU or HDU 9. Non-opiate post operative analgesia 10. Intra-operative antibiotics and fluids _____ Previous secondary outcome measures: Measured from patients' medical records: 1. Postoperative pain scores assessed by FLACC up to 48 hours 2. Intra- and post-operative analgesia requirements until discharge (mg) 3. Time to first analgesic requirement 4. Time to first feed (time taken to establish milk feed following an initial trial of water or milk) 5. Time to discharge from recovery and hospital 6. Adverse events (to discharge and at 1st 6-week outpatient appointment) 7. Block problems (to discharge and at 1st 6-week outpatient appointment) 8. Postoperative nausea and vomiting 9. Airway complications (reported to discharge)	—

Measure

Time frame

Current secondary outcome measures as of 04/05/2021: Measured from patients' medical records: 1. Time to first analgesic requirement 2. Time to discharge from recovery and hospital 3. Block problems 4. Airway complications 5. Postoperative nausea and vomiting Other data collected: 6. Type of general anaesthetic 7. Surgical infiltration 8. Unplanned admission to ICU or HDU 9. Non-opiate post operative analgesia 10. Intra-operative antibiotics and fluids _____ Previous secondary outcome measures: Measured from patients' medical records: 1. Postoperative pain scores assessed by FLACC up to 48 hours 2. Intra- and post-operative analgesia requirements until discharge (mg) 3. Time to first analgesic requirement 4. Time to first feed (time taken to establish milk feed following an initial trial of water or milk) 5. Time to discharge from recovery and hospital 6. Adverse events (to discharge and at 1st 6-week outpatient appointment) 7. Block problems (to discharge and at 1st 6-week outpatient appointment) 8. Postoperative nausea and vomiting 9. Airway complications (reported to discharge)

—

Countries

Ireland

Contacts

Public ContactOrla Kerr

orlakerr@doctors.org.uk+44 (0)894979754

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026