Nerve Blocks for Pediatric Knee Surgery

Overseen By Alex Sideris, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Hospital for Special Surgery, New York

Disqualifiers: Revision, bilateral, general anesthesia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of nerve blocks to determine which aids better recovery in children after knee surgery. It compares each block's effectiveness in pain relief, the amount of pain medication needed, and the participants' recovery experiences. The trial includes children aged 8-18 undergoing surgery on their ACL or MPFL, both knee ligaments. Participants will receive one of the two nerve blocks, which may involve Bupivacaine (a local anesthetic) or Dexamethasone (a corticosteroid), and will track their pain and medication use. The study aims to enhance pain management and recovery for young patients after knee surgery. As a Phase 4 trial, this research involves treatments already FDA-approved and proven effective, aiming to understand their benefits for more patients.

Do I need to stop my current medications for the trial?

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 is the safety track record for these treatments?

Research has shown that bupivacaine is safe and effective for nerve blocks in managing pain after knee surgery in children. Bupivacaine, commonly used in regional anesthesia, provides good pain relief with few side effects. Studies indicate that adding dexamethasone to bupivacaine enhances the quality and duration of pain relief without increasing the risk of nerve problems. This combination does not significantly raise the chance of infections or affect wound healing.

The trial is in Phase 4, indicating that the treatment has already been approved for other uses. This suggests that both bupivacaine and dexamethasone have been thoroughly studied for safety. While individual experiences may vary, these treatments are generally well-tolerated with a low risk of serious side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using nerve blocks with bupivacaine and dexamethasone for pediatric knee surgeries because they offer a targeted pain relief approach that could potentially reduce the need for opioids, which are commonly used in pain management. Bupivacaine is a local anesthetic that provides long-lasting pain relief by directly blocking nerve signals, while dexamethasone is a steroid that may enhance and prolong this effect, resulting in more efficient pain control. Unlike systemic medications that affect the whole body, nerve blocks act at the specific site of surgery, which can lead to fewer side effects and a quicker recovery for young patients undergoing ACL or MPFL surgeries.

What evidence suggests that this trial's nerve block techniques could be effective for pediatric knee surgeries?

In this trial, pediatric subjects undergoing knee surgeries will receive nerve blocks using a mix of bupivacaine and dexamethasone. Research has shown that this combination can greatly improve pain relief after surgery. One study found that adding dexamethasone to bupivacaine extended pain relief from about 19 hours to almost 26 hours. This combination also reduced the need for opioids, which are strong painkillers, in the first two days after surgery. The evidence suggests that these nerve blocks can aid recovery by effectively managing pain and reducing the need for medication. Participants will be randomized to receive either the adductor canal block (ACB) or the anterior femoral cutaneous nerve block (AFCNB) as part of their treatment. ^{5 6 7 8 9}

Who Is on the Research Team?

Kathryn DelPizzo, MD

Principal Investigator

Hospital for Special Surgery, New York

Are You a Good Fit for This Trial?

This trial is for pediatric patients weighing at least 40kg and aged 8-18, undergoing ACL or MPFL knee surgeries with participating surgeons. It's not specified who can't join the trial.

Inclusion Criteria

I weigh at least 40kg.

I had ACL or MPFL surgery with a participating surgeon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either anterior femoral cutaneous nerve block (AFCNB) or adductor canal block (ACB) during ACL or MPFL surgeries

1 day

1 visit (in-person, surgery day)

Immediate Postoperative Monitoring

Opioid consumption and pain levels are monitored for 48 hours post-surgery

48 hours

Follow-up

Participants are monitored for postoperative function, opioid consumption, and pain management satisfaction

6 months

Multiple visits (in-person and telephone) at 2 weeks, 6 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Dexamethasone

Trial Overview The study compares two types of nerve blocks in children's knee surgery: anterior femoral cutaneous nerve block (AFCNB) and adductor canal block (ACB). It looks at post-surgery function, pain levels, opioid use, sensory deficits, and patient satisfaction.

How Is the Trial Designed?

Group I: Medial Patellofemoral Ligament (MPFL) surgeries Experimental Treatment 2 Interventions

Pediatric subjects who underwent a Medial Patellofemoral Ligament (MPFL) surgery and are randomized to receive either the adductor canal block (ACB) or the anterior femoral cutaneous nerve block (AFCNB).

Group II: Anterior Cruciate Ligament (ACL) surgeries Experimental Treatment 2 Interventions

Pediatric subjects who underwent a Anterior Cruciate Ligament (ACL) surgery and are randomized to receive either the adductor canal block (ACB) or the anterior femoral cutaneous nerve block (AFCNB).

Who Is Running the Clinical Trial?

Hospital for Special Surgery, New York

Lead Sponsor

Trials

257

Recruited

61,800+

Published Research Related to This Trial

The addition of intravenous dexmedetomidine (DexM) to systemic dexamethasone did not significantly prolong the duration of analgesia provided by quadruple nerve blocks in patients undergoing total knee arthroplasty, with similar median durations of analgesia in both DexM and placebo groups.

While DexM did not enhance pain relief, it was associated with side effects such as bradycardia and hypotension, leading to a longer recovery room stay, indicating potential safety concerns when used in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total knee arthroplasty under quadruple nerve block with ropivacaine 0.32%: effect of addition of intravenous dexmedetomidine to intravenous dexamethasone on analgesic duration. Chassery, C., Marty, P., Rontes, O., et al.[2021]

In a study of 60 patients undergoing knee arthroscopy, adding dexamethasone to bupivacaine significantly prolonged the duration of sensory block from 12.52 hours to 17.42 hours, enhancing postoperative pain management.

Patients receiving dexamethasone reported higher satisfaction scores and required analgesics later compared to the control group, indicating that dexamethasone improves both pain relief and overall patient experience after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Ibrahim, AS., Aly, MG., Farrag, WS., et al.[2019]

In a pilot study involving 49 patients undergoing foot and ankle surgery, the addition of 8 mg dexamethasone to nerve blocks did not significantly improve the duration of pain relief or reduce the incidence of postoperative neuropathic complications compared to nerve blocks alone.

The study suggests that while dexamethasone is commonly used to enhance pain management, its effectiveness in this context remains uncertain, indicating the need for further research with a larger sample size to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication. Noori, N., Anand, K., Pfeffer, G., et al.[2021]

Adding dexamethasone to bupivacaine for femoral nerve blocks significantly prolonged the duration of analgesia from 18.8 hours to 25.7 hours, enhancing pain management after total knee replacement surgery.

While total morphine consumption was similar between the two groups, patients receiving dexamethasone required less morphine in the first 6 hours post-surgery, indicating improved early pain control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone as adjuvant for femoral nerve block following knee arthroplasty: a randomized, controlled study. Sherif, AA., Elsersy, HE.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06590402

Anterior Femoral and Adductor Canal Nerve Blocks in ... This pilot clinical trial aims to find out what the differences are between anterior femoral cutaneous nerve block (AFCN) and adductor canal block (ACB) for ...

2. withpower.com withpower.com/trial/nerve-blocks-for-pediatric-knee-surgery-79d2f

Nerve Blocks for Pediatric Knee Surgery Adding dexamethasone to bupivacaine for femoral nerve blocks significantly prolonged the duration of analgesia from 18.8 hours to 25.7 hours, enhancing pain ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12002161/

Perineural dexamethasone added to peripheral nerve ... The authors concluded that it reduced pain and opioid use during the first two days after surgery [18]. Another meta-analysis of nine RCTs also found decreased ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2020/04170/the_efficacy_of_dexamethasone_on_pain_management.4.aspx

The efficacy of dexamethasone on pain management ... The impact of dexamethasone on pain management for knee arthroscopy remains controversial. We conduct a systematic review and meta-analysis to explore the ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524007910

Regional and Local Anesthesia in Pediatric Orthopaedic ... HB treatment effect on pain severity was significantly better than PSA. No statistically significant reduction failure or adverse effects between HB and PSA ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4644165/

Regional anesthesia for pediatric knee surgery: a review of ... PNBs for pediatric knee surgery are emerging as a safe and effective technique for postoperative pain management. Several studies in children have demonstrated ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524004401

Single-Shot Versus Continuous Nerve Blocks for Pediatric ... Our findings indicate that both FNC and SSNB are viable options with similar efficacy for postoperative pain management in pediatric ACL reconstruction.

8. jposna.com jposna.com/article/S2768-2765(24)00791-0/fulltext

Regional and Local Anesthesia in Pediatric Orthopaedic ... The authors concluded that FSNB provides better analgesia with fewer side effects than the LIA group. Schloss et al. retrospectively investigated the outcomes ...

9. link.springer.com link.springer.com/article/10.1007/s44254-025-00095-5

Efficacy and safety of liposomal bupivacaine administration ... Outcome data included adverse events, postoperative opioid use, postoperative pain, length of hospital stay, and total cost of hospitalization.