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

140 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. However, if you use opioids daily, you cannot participate in the trial.

What data supports the effectiveness of the drug ropivacaine 0.2% for postoperative pain?

Research shows that ropivacaine, when used at low concentrations like 0.2%, is effective in blocking pain after surgery, as seen in studies involving different surgical procedures. It has been found to reduce pain intensity and the need for additional pain medication. ^{1 2 3 4 5}

Is ropivacaine 0.2% safe for use in humans?

Ropivacaine is generally considered safe for use in humans, with a lower risk of heart-related side effects compared to similar drugs like bupivacaine. However, there have been a few reports of central nervous system side effects, especially at higher concentrations or if accidentally injected into a blood vessel. ^{6 7 8 9 10}

How is the drug ropivacaine 0.2% unique for postoperative pain management?

Ropivacaine 0.2% is unique because it provides effective postoperative pain relief with a lower risk of heart-related side effects compared to similar drugs like bupivacaine. It is often used in lower concentrations for pain management after surgery, offering a safer option for patients. ^{2 3 7 11 12}

What is the purpose of this trial?

This will be a randomized comparison of continuous local anesthetic infusion with patient controlled boluses (PCA) to patient-titratable automated boluses with patient controlled boluses (PCA) for both infraclavicular and popliteal-sciatic perineural catheters. The overall goal is to determine the relationship between method of local anesthetic administration (continuous with PCA vs. titratable intermittent dosing with PCA) for these two perineural catheter locations and the resulting pain control. The investigators hypothesize that, compared with a traditional fixed, continuous basal infusion initiated prior to discharge, perineural local anesthetic administered with titratable automated boluses at a lower dose and a 5-hour delay following discharge will (1) provide at least noninferior analgesia during the period that both techniques are functioning; and, (2) will result in a longer overall duration of administration \[dual primary end points\].

Research Team

Brian Ilfeld, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Combination of pre-emptive port-site and intraoperative intraperitoneal ropivacaine for reduction of postoperative pain: a prospective cohort study. [2022]

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

Ropivacaine wound infiltration: a fast-track approach in patients undergoing thoracotomy surgery. [2019]

3. Lebanon 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. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Postoperative analgesia by combined continuous infusion and patient-controlled epidural analgesia (PCEA) following hip replacement: ropivacaine versus bupivacaine. [2022]

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

Evaluation of efficacy and plasma concentrations of ropivacaine in continuous axillary brachial plexus block: high dose for surgical anesthesia and low dose for postoperative analgesia. [2019]

6. Spain pubmed.ncbi.nlm.nih.gov

[Convulsions induced by ropivacaine after brachial plexus block]. [2018]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Clinical application of ropivacaine for the lower extremity. [2019]

8. India pubmed.ncbi.nlm.nih.gov

Ropivacaine: A review of its pharmacology and clinical use. [2022]

9. Poland pubmed.ncbi.nlm.nih.gov

Safety of pre-incisional low-dose ropivacaine infiltration in bilateral axillo-breast approach thyroidectomy: a retrospective study. [2023]

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

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

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

Epidural, intrathecal pharmacokinetics, and intrathecal bioavailability of ropivacaine. [2018]

12. Serbia pubmed.ncbi.nlm.nih.gov

[Assessment of ropivacaine postoperative analgesic effect after periapical maxillary incisors surgery]. [2019]