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

Trial Summary

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 data supports the effectiveness of the drug Bupivacaine and Dexamethasone for nerve blocks in pediatric knee surgery?

Research shows that adding dexamethasone to bupivacaine can improve the quality and duration of pain relief after knee surgeries, as seen in studies involving knee arthroscopy and total knee replacement. This suggests that the combination may be effective for pediatric knee surgery as well. ^{1 2 3 4 5}

Is it safe to use nerve blocks with bupivacaine and dexamethasone in children undergoing knee surgery?

Studies have shown that adding dexamethasone to bupivacaine for nerve blocks is generally safe, with no significant increase in nerve complications, although more research is needed to confirm these findings. ^{1 2 3 4 6}

How does the drug used in nerve blocks for pediatric knee surgery differ from other treatments?

The use of dexamethasone in nerve blocks for pediatric knee surgery is unique because it is added to prolong the duration of pain relief after surgery. This approach enhances the effectiveness of local anesthetics, providing longer-lasting pain control compared to using local anesthetics alone. ^{1 2 3 4 7}

What is the purpose of this trial?

The goal of this pilot clinical trial is to compare anterior femoral cutaneous nerve block (AFCN) to adductor canal block ACB) for pediatric patients undergoing either anterior cruciate ligament (ACL) or medial patellofemoral ligament (MPFL). The aims of this trial are: * To measure postoperative functional outcomes in patients who received AFCNB vs. ACB. * To calculate postoperative opioid requirements in pediatric knee surgeries that received AFCNB vs. ACB. * To calculate pain intensity levels at rest and with ambulation in patients who received AFCNB vs. ACB. * To quantify sensory deficits in patients who received AFCNB vs. ACB. * To assess patient-reported outcome measures (e.g., pain expectation scale, pain management satisfaction, PROMIS Pediatric Short Form v1.0 - Physical Activity, PROMIS Scale v1.2 - Global Health) in patients 8-18 years of age who received AFCNB vs. ACB. Subjects undergoing ACL procedures will be compared between those who received the adductor canal block to those who received the anterior femoral cutaneous nerve block. The researchers will also compare individuals who underwent MPFL procedures and received an anterior femoral cutaneous nerve block with those who received the adductor canal block. Participants will: * Be randomized to receive either the AFCNB or ACB in addition to standard of care analgesia. * Maintain a patient diary to document daily pain meds/pain scores * Complete follow up surveys/questionnaires via telephone and during their office visits with surgeons.

Research Team

Kathryn DelPizzo, MD

Principal Investigator

Hospital for Special Surgery, New York

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Protocol of DEXPED trial: efficacy of intravenous dexamethasone, administered at the time of analgesic blocking of the lower limb, on postoperative pain in children: a randomised, placebo-controlled, double-blind trial. [2021]

3. England 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. [2019]

4. England 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. [2021]

5. France pubmed.ncbi.nlm.nih.gov

Intravenous dexamethasone does not prolong the duration of pudendal nerve block in infants and children undergoing hypospadias surgery: A randomized clinical trial. [2023]

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

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication. [2021]

7. Greece pubmed.ncbi.nlm.nih.gov

Efficacy of perineural dexamethasone with ropivacaine in adductor canal block for post-operative analgesia in patients undergoing total knee arthroplasty: A randomized controlled trial. [2020]