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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether ropivacaine, a numbing medicine, can reduce pain and the need for pain pills after ACL surgery. It examines the effectiveness of this medicine, administered as a nerve block (a numbing injection near the nerves), for children and teens undergoing ACL reconstruction. Participants will either receive the ropivacaine injection or not during their surgery, and their pain and pill use will be monitored for a week. The trial includes individuals aged 13 and older who require ACL reconstruction with specific graft types and can provide consent or have a representative do so. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that ropivacaine is likely to be safe for humans?

Research shows that ropivacaine is generally safe for people. Studies have found that doses up to 800 mg can be used safely for surgery and post-surgery pain relief. Often used as a local anesthetic during operations and for short-term pain control, it helps avoid issues related to high doses when used correctly.

In past experiences, ropivacaine effectively eased pain after surgeries. It provides a straightforward and safe way to manage pain, making it a dependable option for many. The safety data is encouraging, prompting its testing for new uses, such as managing pain after ACL surgery in this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for postoperative pain in sports injuries, which often include oral pain medications like opioids and NSAIDs, Ropivacaine is unique because it is administered as a peripheral nerve block. This method targets pain at its source by directly numbing the nerves in the affected area, potentially reducing the need for systemic pain medications and their side effects. Researchers are excited about Ropivacaine because it offers a localized approach to pain management, which can lead to better pain control and faster recovery for patients.

What evidence suggests that ropivacaine might be an effective treatment for postoperative pain in sports injuries?

This trial will compare the effectiveness of ropivacaine in managing postoperative pain for sports injuries. Studies have shown that ropivacaine reduces pain after surgery by blocking nerve signals in the injection area, lowering pain without significantly affecting muscle movement. This is particularly beneficial for individuals who need to remain active after surgery. Research also indicates that ropivacaine can reduce the need for narcotic painkillers, which are often used to manage postoperative pain, thereby lowering the risk of narcotic side effects. Overall, ropivacaine provides effective pain relief and aids recovery while maintaining mobility. Participants in this trial will receive either a Peripheral Nerve Block with ropivacaine or no Peripheral Nerve Block to assess its effectiveness. ^{5 6 7 8 9}

Who Is on the Research Team?

Philip Wilson, MD

Principal Investigator

Texas Scottish Rite Hospital for Children

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

* A 20 mL Adductor PNB will be injected where determined as best place by anesthesiologist * Patient will receive 0.2% plain Ropivacaine (perineural injection) regardless of weight * Patient will be given a purple surgical marker dot at/near the site of injection by the anesthesiologist

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

\- Patients will be given a purple surgical marker dot at/near the site where a PNB would be administered by the anesthesiologist, if they were randomized to the placebo group

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+

Published Research Related to This Trial

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 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 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]

Citations

1.

withpower.com

withpower.com/trial/phase-2-athletic-injuries-8-2024-29fba

Ropivacaine for Postoperative Pain in Sports Injuries

It provides effective pain relief with less impact on muscle movement, which can be beneficial for patients needing to maintain mobility after surgery.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11630916/

A bibliometric analysis from 2003 to 2022 - PMC

Furthermore, many studies have demonstrated the effectiveness of ropivacaine in treating postoperative pain. However, there are few studies ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03349034

Local Infusion of Ropivacaine for Post-Op Pain Control ...

In this study the clinical team aims to better control donor site pain utilizing local, targeted analgesia to relieve pain at the donor site for osseocutaneous ...

4.

journals.lww.com

journals.lww.com/anesthesia-analgesia/fulltext/2022/12000/postoperative_analgesic_efficacy_and_safety_of.19.aspx

Postoperative Analgesic Efficacy and Safety of Ropivacaine...

Infiltration of ropivacaine and Diprospan can achieve satisfactory postoperative pain relief after craniotomy; it is a simple, easy, and safe technique, worth ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352556825000128

determining the minimum effective ropivacaine ...

The postoperative pain score and the rescue analgesics data are reported in Table 3. Out of 54 patients, 8 experienced postoperative nausea, and 6 ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2018/020533s035lbl.pdf

Naropin® (ropivacaine HCl) Injection - accessdata.fda.gov

cumulative dose of up to 770 mg Naropin administered over 24 hours is well tolerated in adults when used for postoperative pain management: i.e., 2016 mg.

7.

medsafe.govt.nz

medsafe.govt.nz/profs/datasheet/n/Naropininj.pdf

DATA SHEET

Cumulative doses up to 800 mg ropivacaine for surgery and post operative analgesia administered over 24 hours were well tolerated in adults, as were ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37085287/

Population pharmacokinetic and safety analysis of ...

Our data suggested that using a maximum ropivacaine dose of 2.5 mg/kg based on ideal body weight would have prevented all toxicity events.

9.

go.drugbank.com

go.drugbank.com/drugs/DB00296

Ropivacaine: Uses, Interactions, Mechanism of Action

Ropivacaine is an amide-type local anesthetic used for local or regional anesthesia during surgery and for short-term management of acute pain.