Nerve Block vs Local Anesthesia for Cleft Palate Surgery

Overseen By Haley Nitchie, MHA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Infection, Coagulopathies, Bleeding disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Immediate post-operative period

46 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will consist of patients ages 6-18 who are undergoing a surgery on the hard or soft palate of the mouth (palatoplasty), with removal of bone from the front of the hip (anterior iliac bone graft harvesting). The patients will be randomized to receive either a unilateral QL block by an anesthesiologist, or local anesthetic infiltration at the surgical incision by the surgeon. The primary aim will be assessing post-operative pain in the first 48 hours after surgery. Secondary outcomes will include pain medication use in the first 48 hours after surgery, block resolution time, and evaluating any complications associated with the QL block or local anesthetic infiltration.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for cleft palate surgery?

Research shows that the quadratus lumborum block (QL block) is effective in providing pain relief after various surgeries, such as hernia repair and abdominal surgeries, by reducing the need for additional pain medication. This suggests it could be a useful option for managing pain after cleft palate surgery as well. ^{1 2 3 4 5}

Is the quadratus lumborum block safe for use in humans?

The quadratus lumborum block (QLB) has been used safely in various surgeries, including in children, to provide pain relief after surgery. Studies have shown it to be effective and well-tolerated, with families reporting satisfaction with pain management. ^{1 6 7 8 9}

How does the treatment of nerve block vs local anesthesia for cleft palate surgery differ from other treatments?

The treatment using a quadratus lumborum block (QL block) for cleft palate surgery is unique because it involves a regional anesthesia technique that targets nerves in the lower back to provide pain relief, potentially reducing the need for opioids and minimizing the risk of airway obstruction, unlike traditional local anesthetic infiltration which is applied directly to the surgical site. ^{10 11 12 13 14}

Research Team

Nicole McCoy, M.D.

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

This trial is for children and teenagers aged 6-18 who are having surgery on the roof of their mouth, which may also involve taking bone from the hip. Participants must be suitable for either a QL block or local anesthetic as part of their pain management after surgery.

Inclusion Criteria

I am having surgery to repair my palate using bone from my hip.

ASA Status Range: 1-3

I am between 6 and 18 years old.

Exclusion Criteria

Non-English Speaking/Writing

Subjects or their parent/guardian unable or choose to not give informed consent/assent

I have difficulty reporting pain due to cognitive or developmental issues.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo palatoplasty surgery with either a QL block or local anesthetic infiltration for pain management

Immediate post-operative period

1 visit (in-person)

Post-operative Monitoring

Participants' pain scores and opioid consumption are monitored for 48 hours post-surgery

48 hours

Follow-up

Participants are monitored for block resolution and any complications up to 7 days post-surgery

7 days

Treatment Details

Interventions

• Local anesthetic infiltration
• Quadratus lumborum block

Trial Overview The study compares two types of pain relief methods after palatoplasty: a 'QL block' given by an anesthesiologist versus a local anesthetic directly at the surgical site by the surgeon. It will measure how well each method controls pain in the first two days post-surgery and monitor any complications.

Participant Groups

Group I: Local anesthetic infiltration Active Control 1 Intervention

Patient will undergo induction of anesthesia as deemed appropriate by the attending pediatric anesthesiologist assigned to the case. After induction of anesthesia and securement of appropriate airway device the patient will be turned over to the surgical team to proceed with the operation. The surgeon will proceed with usual injection of local anesthetic as their standard of care; this medication will be charted by the circulating nurse in the Medication Administration Record with local anesthetic type and amount. At the conclusion of the procedure, to maintain the blind, the patient will have a bandage placed where the QL block would have been performed.

Group II: Quadratus lumborum block Active Control 1 Intervention

After induction of anesthesia and securement of appropriate airway device, the patient will be placed in position for the QL block. Using ultrasound guidance, the pediatric anesthesiology attending will perform unilateral QL block on the side of the anterior iliac bone graft harvest. The dose will be 0.2% ropivacaine, 1 mL per kilogram to a max of 20 mL with an additive of dexamethasone 4 mg. Ultrasonography will be used to identify external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A 50 mm-150 mm block needle will be advanced under ultrasound guidance. Ropivacaine will be injected slowly with frequent aspiration to rule out incorrect needle placement. The anesthetic is deposited at the lateral edge of the QL after penetrating the transversus abdominus aponeurosis. Injection will continue to be observed with real time US guidance.

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Findings from Research

The quadratus lumborum block (QLB) is a safe and effective method for providing long-lasting pain relief, as demonstrated in a case involving a 3-year-old patient who underwent inguinal hernia repair.

The use of ultrasound guidance in administering the QLB allows for precise delivery of local anesthetic, resulting in successful postoperative analgesia and high family satisfaction with the patient's pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block for postoperative analgesia in a pediatric patient. Öksüz, G., Gürkan, Y., Urfalıoglu, A., et al.[2020]

The quadratus lumborum block (QLB) effectively managed postoperative pain in a 46-year-old female patient undergoing simultaneous cholecystectomy and nephrectomy, resulting in a Visual Analog Scale (VAS) score of 0 after 24 hours.

The patient required only 13 mg of morphine for pain management post-surgery, suggesting that QLB may reduce the need for opioid analgesics in similar surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quadratus lumborum block for both cholecystectomy and right-sided nephrectomy]. Gürkan, Y., Yörükoğlu, HU., Ulugöl, H., et al.[2020]

The posterior quadratus lumborum block (QLB2) significantly reduces pain scores at 6, 12, and 24 hours after abdominal surgery compared to control groups, based on a meta-analysis of 14 studies with 1001 patients.

QLB2 also decreases opioid consumption within the first 24 hours post-surgery, indicating its effectiveness in managing postoperative pain, especially for patients under general anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Posterior Quadratus Lumborum Block for Acute Postoperative Analgesia in Adult Patients: A Meta-Analysis of Randomized Controlled Trials. Lin, C., Wang, X., Qin, C., et al.[2022]

The quadratus lumborum (QL) block is an effective method for providing pain relief after abdominal surgeries, allowing for analgesia without the side effects associated with neuraxial blocks.

In a case series of eight patients, the QL block was successfully administered via continuous infusion, resulting in a median opioid consumption of 110 mg of morphine equivalents over the first 72 hours post-surgery, indicating its potential as part of a multimodal pain management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bilateral continuous posterior quadratus lumborum block for analgesia after open abdominal surgery: A prospective case series. Ali Sakr Esa, W., Hamadnalla, H., Cohen, B., et al.[2020]

The Quadratus lumborum (QL) block significantly reduces opioid requirements in patients undergoing cesarean deliveries and renal surgeries, based on a systematic review of 22 studies.

QL block may provide effective postoperative analgesia for up to 24 hours, although evidence for its effectiveness in other types of surgeries is limited and further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. Jin, Z., Liu, J., Li, R., et al.[2021]

The quadratus lumborum block (QLB) provided significantly longer pain relief compared to intravenous tramadol, with the first analgesic requirement occurring 8 hours after surgery for the QLB group versus 3.5 hours for the tramadol group.

Patients receiving the QLB required less oral paracetamol in the first 24 hours post-surgery, indicating that QLB is an effective analgesic method for pediatric patients undergoing lower abdominal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of quadratus lumborum block on postoperative analgesic requirements in pediatric patients: a randomized controlled double-blinded study. Genç Moralar, D., Tok Cekmecelioglu, B., Aslan, M., et al.[2021]

The study compared different needle approaches for ultrasound-guided quadratus lumborum (QL) blocks in cadavers, finding that the alternative approach resulted in better dye spread to the transversus abdominis and transversalis fascia compared to conventional methods.

Both approaches effectively stained the middle thoracolumbar fascia, but all lateral QL blocks showed some degree of unwanted intramuscular or subcutaneous infiltration, indicating potential limitations in their application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cadaveric Evaluation of Different Approaches for Quadratus Lumborum Blocks. Yang, HM., Park, SJ., Yoon, KB., et al.[2018]

The ultrasound-guided quadratus lumborum (QL) block provided significantly longer postoperative analgesia (approximately 545 minutes) compared to the ilioinguinal-iliohypogastric (IIIH) nerve block and local wound infiltration (approximately 351 minutes), indicating its superior efficacy for pain management after unilateral inguinal surgeries.

Patients receiving the QL block reported lower pain scores and required less additional analgesics, along with higher satisfaction scores (3.93 vs. 3.4), highlighting the benefits of this technique in enhancing patient comfort and reducing medication needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block versus ilioinguinal-iliohypogastric nerve block with wound infiltration for postoperative analgesia in unilateral inguinal surgeries: A randomised controlled trial. Yadav, M., Agrawal, M., Bansal, P., et al.[2023]

In a study of 82 colorectal cancer patients undergoing laparoscopic surgery, preoperative anterior quadratus lumborum block (QLB-LSAL) significantly reduced postoperative morphine consumption compared to lateral QLB (29.2 mg vs 40.5 mg, p < 0.001).

Patients receiving QLB-LSAL also experienced a longer time before needing additional pain relief (10.4 hours vs 3.7 hours, p < 0.001), indicating better pain management with this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anterior Quadratus Lumborum Block at Lateral Supra-arcuate Ligament vs Lateral Quadratus Lumborum Block for Postoperative Analgesia after Laparoscopic Colorectal Surgery: A Randomized Controlled Trial. Shi, R., Shao, P., Hu, J., et al.[2023]

In a study involving 60 children undergoing cleft palate repair, both levobupivacaine and bupivacaine were found to be equally effective for pain management, with no significant differences in pain scores or serious complications.

Bilateral maxillary nerve block (MNB) using either anesthetic provided effective pain relief, highlighting it as a safe and straightforward method for managing postoperative pain in children after cleft palate surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study. Mostafa, MF., Herdan, R., Elshazly, M.[2019]

In a study involving 20 patients with cleft lip, a bilateral infraorbital nerve block using a combination of lidocaine and bupivacaine was successfully performed, allowing for cleft lip repair under regional anesthesia without complications.

The procedure provided effective postoperative analgesia lasting an average of 16.5 hours, demonstrating the potential for this technique to enhance pain management in cleft lip surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional anesthesia for cleft lip repair: a preliminary study. Eipe, N., Choudhrie, A., Pillai, AD., et al.[2022]

The combined infraorbital and external nasal nerve blocks can effectively provide analgesia for cleft lip and palate repair, allowing procedures to be performed under local anesthesia without the need for general anesthesia or sedation in adolescents and adults.

This technique significantly reduces the need for postoperative opioid analgesia, particularly in children, thereby minimizing the risk of airway obstruction and other perioperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined use of infraorbital and external nasal nerve blocks for effective perioperative pain control during and after cleft lip repair. Salloum, ML., Eberlin, KR., Sethna, N., et al.[2018]

The study identified the average location of the infraorbital foramen in pediatric populations, finding it within 2 mm of a midpoint between the nasospinale and jugale across different age groups, which can help improve the accuracy of infraorbital nerve blocks for pain management after cleft lip surgery.

This information is particularly valuable in settings with limited access to ultrasound technology, ensuring that healthcare providers can perform effective nerve blocks even in developing countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infraorbital foramen location in the pediatric population: A guide for infraorbital nerve block. Zdilla, MJ., Russell, ML., Koons, AW.[2019]

Ultrasound-guided suprazygomatic maxillary nerve blocks were successfully performed in 25 children undergoing cleft palate repair, with a high success rate of local anesthetic spread observed in 94% of cases.

The procedure demonstrated low pain scores and minimal opioid use, with 80% of patients not requiring continuous opioid infusion, indicating effective pain management and a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: a descriptive prospective study. Sola, C., Raux, O., Savath, L., et al.[2022]

References

1. Turkey pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block for postoperative analgesia in a pediatric patient. [2020]

2. Turkey pubmed.ncbi.nlm.nih.gov

[Quadratus lumborum block for both cholecystectomy and right-sided nephrectomy]. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Ultrasound-Guided Posterior Quadratus Lumborum Block for Acute Postoperative Analgesia in Adult Patients: A Meta-Analysis of Randomized Controlled Trials. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Bilateral continuous posterior quadratus lumborum block for analgesia after open abdominal surgery: A prospective case series. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Single injection Quadratus Lumborum block for postoperative analgesia in adult surgical population: A systematic review and meta-analysis. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Effect of quadratus lumborum block on postoperative analgesic requirements in pediatric patients: a randomized controlled double-blinded study. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Cadaveric Evaluation of Different Approaches for Quadratus Lumborum Blocks. [2018]

8. India pubmed.ncbi.nlm.nih.gov

Ultrasound-guided quadratus lumborum block versus ilioinguinal-iliohypogastric nerve block with wound infiltration for postoperative analgesia in unilateral inguinal surgeries: A randomised controlled trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Anterior Quadratus Lumborum Block at Lateral Supra-arcuate Ligament vs Lateral Quadratus Lumborum Block for Postoperative Analgesia after Laparoscopic Colorectal Surgery: A Randomized Controlled Trial. [2023]

10. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparative study of levobupivacaine and bupivacaine for bilateral maxillary nerve block during pediatric primary cleft palate surgery: a randomized double-blind controlled study. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Regional anesthesia for cleft lip repair: a preliminary study. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Combined use of infraorbital and external nasal nerve blocks for effective perioperative pain control during and after cleft lip repair. [2018]

13. France pubmed.ncbi.nlm.nih.gov

Infraorbital foramen location in the pediatric population: A guide for infraorbital nerve block. [2019]

14. France pubmed.ncbi.nlm.nih.gov

Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: a descriptive prospective study. [2022]