Ropivacaine for Postoperative Pain in Sports Injuries

Overseen By Anna Wilhelmy, MS

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Texas Scottish Rite Hospital for Children

Disqualifiers: Fracture repair, Pregnancy, Hypersensitivity, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

160 Participants Needed

Trial Summary

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 focuses on the use of ropivacaine for pain management during ACL surgery.

What data supports the effectiveness of the drug Ropivacaine for postoperative pain in sports injuries?

Ropivacaine is effective for pain relief after surgeries, including knee surgeries, and is known for its safety and reduced side effects compared to similar drugs like bupivacaine. It is particularly effective for regional anesthesia and managing postoperative pain, making it a good option for sports injury surgeries. ^{1 2 3 4 5}

Is ropivacaine safe for use in humans?

Ropivacaine is generally considered safe for use in humans, with studies showing it has less risk of heart and nervous system problems compared to bupivacaine, another similar drug. However, there have been rare cases of serious issues like heart problems and nerve toxicity when it was accidentally injected into a blood vessel. ^{1 2 3 6 7}

How does the drug Ropivacaine differ from other treatments for postoperative pain in sports injuries?

Ropivacaine is unique because it is a pure S-enantiomer, which makes it safer with less risk of heart and nervous system side effects compared to similar drugs like bupivacaine. It provides effective pain relief with less impact on muscle movement, which can be beneficial for patients needing to maintain mobility after surgery. ^{1 2 3 8 9}

What is the purpose of this trial?

The goal of this randomized clinical trial is to determine if single-shot ropivacaine peripheral nerve blocks (PNB - perineural injections) for anterior cruciate ligament (ACL) reconstruction procedures in pediatric orthopaedic sports medicine patients provides significant pain relief and decreased narcotic use. The main questions it aims to answer are: * Does ropivacaine significantly reduce Visual Analog Scale (VAS) pain scores and pain levels up to one week postoperatively? * Does ropivacaine significantly decrease narcotic use (number of pills taken) up to one week postoperatively? Researchers will compare the pain outcomes and narcotic use of participants who receive a single-shot ropivacaine peripheral nerve block to those of participants who do not receive a single-shot ropivacaine peripheral nerve block for their ACL reconstruction surgery. The goal is to understand if there is a significant difference in participant pain outcomes and narcotic use outside the first 24 hours postoperatively. Participants will: * receive either a single-shot ropivacaine peripheral nerve block intraoperatively or no peripheral nerve block during their ACL Quadriceps tendon graft or bone patellar tendon bone graft reconstruction surgery. * receive and complete questionnaires at postoperative days 1, 4, and 7 regarding their pain scores, levels, and outcomes, effective pain treatments, overall pain interference, narcotic use (number of pills taken), and overall pain treatment satisfaction * receive and complete secondary outcome measures of functional and psychological outcomes regarding their ACL reconstruction surgery at postoperative day 1

Research Team

Philip Wilson, MD

Principal Investigator

Texas Scottish Rite Hospital for Children

Eligibility Criteria

This trial is for pediatric patients undergoing ACL reconstruction surgery. It's designed to see if a single-shot nerve block with ropivacaine can help manage pain after the operation and reduce the need for narcotics.

Inclusion Criteria

I am at least 10 years old.

I need ACL surgery using a tendon from my knee or thigh.

Parent/patient must be fluent in English

Exclusion Criteria

I am under 10 years old.

I need surgery for a fracture or another specific injury.

I need surgery for a leg injury that isn't mainly for an ACL repair.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Participants are approached for participation and anesthesia doses are administered based on body weight

1 day

1 visit (in-person)

Intra-operative

Participants receive either a single-shot ropivacaine peripheral nerve block or no block during ACL reconstruction surgery

1 day

1 visit (in-person)

Post-operative

Participants complete questionnaires on pain scores, narcotic use, and satisfaction at postoperative days 1, 4, and 7

1 week

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Ropivacaine

Trial Overview Researchers are testing whether a one-time injection of ropivacaine, given during surgery, can lower pain levels and decrease narcotic use post-surgery compared to not using the nerve block. Participants will report their pain and medication use over a week.

Participant Groups

Group I: Peripheral Nerve Block (PNB) group Active Control 1 Intervention

* Patients will receive a purple surgical marker dot at the decided site of injection * A 20 mL Adductor PNB will be injected intraoperatively at the point of the purple dot * Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight

Group II: No Peripheral Nerve Block (PNB) group Active Control 1 Intervention

* Patients will receive a purple surgical marker dot at a point where a PNB would be injected, if they were randomized to the no peripheral nerve block group * A bandage will be placed over the purple dot and wrapped with the standard gauze/bandage from the surgery

Ropivacaine is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in United States as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in Canada as Naropin for:

• Surgical anesthesia
• Pain relief

Approved in China as Naropin for:

• Surgical anesthesia
• Pain relief

Who Is Running the Clinical Trial?

Texas Scottish Rite Hospital for Children

Lead Sponsor

Trials

23

Recruited

9,000+

Findings from Research

Ropivacaine is a long-acting local anesthetic that effectively blocks nerve signals by inhibiting sodium ion influx, making it suitable for surgical anesthesia and pain relief during and after surgery.

Compared to bupivacaine, ropivacaine has a similar efficacy for nerve blocks but is associated with a lower risk of motor block and reduced potential for central nervous system and cardiac toxicity, making it a safer option for regional anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. Simpson, D., Curran, MP., Oldfield, V., et al.[2022]

Ropivacaine, a long-acting local anesthetic, is safer than bupivacaine, showing less cardiovascular and central nervous system toxicity, making it a preferable option for various types of anesthesia.

While ropivacaine provides similar sensory block effects as bupivacaine, it causes less motor block, which may be beneficial in certain surgical situations, although its higher cost could limit its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine. Owen, MD., Dean, LS.[2022]

Ropivacaine is a long-acting local anesthetic that has been shown to have a better safety profile than bupivacaine, particularly with reduced cardiovascular toxicity, making it a safer option for various medical procedures.

It is equally effective as bupivacaine for different types of anesthesia, such as epidural and nerve blocks, but causes less motor block, which is beneficial in settings like obstetrics and pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine: a pharmacological review. Hansen, TG.[2018]

References

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

Ropivacaine: a review of its use in regional anaesthesia and acute pain management. [2022]

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

Ropivacaine. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Ropivacaine: a pharmacological review. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Single-dose intra-articular ropivacaine after arthroscopic knee surgery decreases post-operative pain without increasing side effects: a systematic review and meta-analysis. [2018]

5. England pubmed.ncbi.nlm.nih.gov

The intra-articular use of ropivacaine for the control of post knee arthroscopy pain. [2020]

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

Comparison of 0.5% ropivacaine and 0.5% bupivacaine for epidural anesthesia in patients undergoing lower-extremity surgery. [2022]

7. Brazil pubmed.ncbi.nlm.nih.gov

[Accidental intravascular injection of 0.5% ropivacaine during thoracic epidural anesthesia: case reports.]. [2019]

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

Ropivacaine: an update of its use in regional anaesthesia. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

[Levobupivacaine vs. ropivacaine for continuous femoral analgesia after anterior cruciate ligament reconstruction]. [2021]