Local Anesthetic Delivery Methods for Postoperative Pain

Overseen By John J Finneran IV, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, San Diego

Must not be taking: Opioids

Disqualifiers: Neuro-muscular deficit, Morbid obesity, Pregnancy, Incarceration, 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: 9

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of administering pain relief after surgery using the local anesthetic ropivacaine. Researchers aim to determine whether adjustable doses are as effective or superior to a continuous steady dose for pain management and duration of relief. Suitable candidates for this trial include individuals undergoing surgery for a broken wrist or foot/ankle surgery who plan to use a specific type of pain relief catheter post-surgery. As a Phase 4 trial, this research seeks to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you use opioids daily, you cannot participate in the trial.

What is the safety track record for ropivacaine 0.2% in these delivery methods?

Research shows that ropivacaine, the drug used in this study, is generally safe for managing post-surgical pain. Studies have found that a continuous flow of 0.2% ropivacaine is well-tolerated, even over several days. Patients who received it experienced less pain and did not report serious side effects.

Research also indicates that using ropivacaine with adjustable doses is safe. This method can reduce the need for other pain medications, effectively controlling pain. Again, no major safety issues have been reported in these studies.

Both methods use the same amount of ropivacaine, and past studies support their safety. However, individual reactions can vary, so discussing any concerns with a doctor before joining the trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these anesthetic delivery methods for postoperative pain because they offer innovative ways to manage pain more effectively. The continuous infusion method delivers a steady stream of ropivacaine, potentially leading to more consistent pain relief compared to traditional methods like oral pain medications or standard local anesthetic injections. The titratable automated boluses allow patients to receive carefully controlled doses of ropivacaine at regular intervals, which could enhance pain management by allowing adjustments based on individual needs. Both methods emphasize personalized pain control, which may improve patient comfort and reduce reliance on opioids.

What evidence suggests that these anesthetic delivery methods are effective for postoperative pain control?

Research has shown that ropivacaine 0.2% effectively manages post-surgical pain when administered in various ways. In this trial, participants will receive ropivacaine through either continuous infusion or titratable automated boluses. Studies indicate that adjustable automated doses, which allow patients to control their pain relief, can improve pain management and reduce opioid use. One study found that scheduled doses of ropivacaine led to less pain medication use and better pain relief. However, continuous infusion of ropivacaine has sometimes not significantly reduced pain or the need for additional pain medication. Overall, both methods aim to manage pain effectively, but scheduled doses might reduce medication use more. ^{2 3 6 7 8}

Who Is on the Research Team?

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for patients having certain arm or foot/ankle surgeries who will receive a catheter for pain relief after surgery. It's not for those who've used opioids daily in the past month, are pregnant, have nerve/muscle issues in the affected limbs, are incarcerated, had additional surgeries outside of specific areas, or are morbidly obese.

Inclusion Criteria

I am having surgery on my arm or leg and will get a nerve block for pain.

Exclusion Criteria

You have been taking opioid pain medication every day in the last 4 weeks.

Pregnancy

You are in prison.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a continuous infusion or titratable automated boluses of Ropivacaine via perineural catheters for postoperative analgesia

8 days

Daily phone follow-up for 9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain levels and opioid consumption

9 days

Phone follow-up

What Are the Treatments Tested in This Trial?

Interventions

• ropivacaine 0.2%

Trial Overview The study compares two ways to manage pain with ropivacaine after surgery: one group gets a steady drip through a catheter and another gets doses they can control when needed. The goal is to see which method provides better pain control and lasts longer post-discharge.

How Is the Trial Designed?

Group I: Titratable Automated Boluses Experimental Treatment 1 Intervention

Patients will receive patient-titratable intermittent boluses of Ropivacaine 0.2% (8 mL popliteal-sciatic or 11 mL infraclavicular automated bolus every 120 minutes, 4 mL patient controlled bolus with 30-minute lockout).

Group II: Continuous Infusion Active Control 1 Intervention

Patients will receive a continuous infusion of Ropivacaine 0.2% (6 mL/hr popliteal-sciatic and 8 mL/hr infraclavicular, 4 mL patient controlled bolus with 30-minute lockout).

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 40 patients undergoing thoracotomy for esophageal cancer, wound infiltration with ropivacaine significantly reduced postoperative pain and analgesic consumption, leading to improved recovery outcomes.

Patients receiving ropivacaine experienced shorter hospital stays and earlier ambulation, with no significant side effects reported, indicating that it is a safe and effective method for managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ropivacaine wound infiltration: a fast-track approach in patients undergoing thoracotomy surgery. Rao, Z., Zhou, H., Pan, X., et al.[2019]

In a study of 52 patients undergoing ACL reconstruction, the combination of ropivacaine and fentanyl provided better pain relief compared to ropivacaine and clonidine, as indicated by lower VAS scores at 8 hours post-operation.

Patients receiving the clonidine combination required more total analgesic solution and experienced greater motor blockade, as shown by higher Bromage scores, suggesting that fentanyl may be a more effective adjuvant for postoperative analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between ropivacaine 1.5 mg ml(-1) plus fentanyl 2 mg ml(-1) and ropivacaine 1.5 mg ml(-1) plus clonidine 1 mg ml(-1) as analgesic solution after anterior cruciate ligament reconstruction: a randomized clinical trial. Apostolos, K., Georgios, K., Omiros, C., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9113128/

Effects of Different 0.2% Ropivacaine Infusion Regimens ... Programmed intermittent bolus infusion with 0.2% ropivacaine 8 mL/2 h for cIBPB can achieve lower tramadol consumption, along with better analgesia after ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053077018308826

Continuous Ropivacaine Infusion Offers No Benefit in ... Continuous 0.2% ropivacaine infusions at the median sternotomy wound did not reduce postoperative pain or opioid consumption during the first 48 hours after ...

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. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-020-01093-9

Effectiveness of wound infusion of 0.2% ropivacaine by patient ... Our secondary outcomes were the frequency of NRS scores higher than three, patients' satisfaction with the pain relief, the time to recovery and ...

5. cureus.com cureus.com/articles/357510-comparison-of-0375-and-02-ropivacaine-for-postoperative-analgesia-using-ultrasound-guided-pectoral-nerve-block-in-patients-undergoing-breast-cancer-surgery-a-randomized-controlled-study.pdf?email=

Comparison of 0.375% and 0.2% Ropivacaine for ... Conclusion: This study found no significant difference in postoperative pain, antiemetic requirements, or patient satisfaction between 0.375% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17304151/

Safety of 96-hour incision-site continuous infusion ... The aim of this study was to examine the safety of ropivacaine given to patients as a continuous infusion [0.2% (2 mg/mL), 5 mL/h for 96 hours] into a right ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1748681516300845

Continuous wound infiltration with 0.2% ropivacaine versus ... CWI of 0.2% ropivacaine is a better and safe technique for postoperative pain management after costal cartilage graft harvest in children. Introduction.

8. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2778438

Postoperative Pain Treatment With Continuous Local ... Continuous wound infusion with ropivacaine can be advocated as a safe method that is associated with reduced postoperative pain following head ...