Analgesic Device for Postoperative Pain

Overseen By Baharin Abdullah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Opioids, Tramadol, Anticoagulants

Disqualifiers: Neuro-muscular deficit, Immunocompromised, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 7 days

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Postoperative pain remains undertreated with inadequate analgesic options. Opioids have well-known limitations for both individuals and society; single-injection and continuous peripheral nerve blocks provide intense analgesia but are limited in duration to 24-72 hours; and current neuromodulation options-with a duration measured in weeks and not hours-are prohibitively expensive and require an additional procedure. One possible solution is a device currently under investigation to treat postoperative pain. The RELAY system (Gate Science, Moultonborough, New Hampshire) is comprised of a basic catheter-over-needle device to allow administration of a single-injection of local anesthetic via the needle (or catheter) followed by a perineural local anesthetic infusion via the remaining catheter (when desired). Subsequent to the local anesthetic administration, instead of removing the catheter as with all previous continuous peripheral nerve block equipment, electric current may be delivered via the same catheter and an integrated pulse generator for up to 28 days. This is potentially revolutionary because it would allow an anesthesiologist to deliver (1) a single-injection peripheral nerve block; (2) a continuous peripheral nerve block; and (3) neuromodulation using a single device that can theoretically be placed in the same amount of time required for a single-injection peripheral nerve block. Instead of providing fewer than 24 hours of postoperative analgesia, up to 28 days of pain control could be delivered without disruption of existing practice patterns. The ultimate objective of the proposed investigation is to prepare for a randomized clinical trial investigating the use of the RELAY device to provide postoperative analgesia. This feasibility study will be a series of participants all receiving both local anesthetic and electric current via a single device (RELAY, Gate Science, Moultonborough, New Hampshire). The purpose will be to optimize the insertion approach and stimulation administration during the first 7 days following foot and shoulder surgery as well as training the clinical investigators.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using chronic opioids, tramadol, or certain blood thinners other than aspirin.

What data supports the effectiveness of the RELAY system treatment for postoperative pain?

Research shows that patient-controlled analgesia systems, which allow patients to manage their own pain relief, can improve pain management and patient satisfaction after surgery. These systems have been effective in reducing pain and improving patient function in various surgical settings, suggesting that similar technologies like the RELAY system could also be beneficial. ^{1 2 3 4 5}

How is the RELAY system treatment different from other postoperative pain treatments?

The RELAY system is unique because it likely involves a novel device-based approach for managing postoperative pain, which may offer more consistent pain relief compared to traditional methods like systemic narcotics or patient-controlled analgesia. This could potentially reduce the need for narcotics and their associated side effects. ^{6 7 8 9 10}

Research Team

Brian M Ilfeld, MD, Ms

Principal Investigator

University of California, San Diego

Eligibility Criteria

Adults at least 18 years old who are having surgery for rotator cuff repair, total shoulder arthroplasty, hallux valgus correction or ankle arthroplasty/arthrodesis. They must plan to have a single-injection peripheral nerve block and own an Android or Apple smartphone to download a required app.

Inclusion Criteria

I have a smartphone that can download the required app.

I am having surgery for my shoulder, big toe, or ankle.

I am scheduled for a one-time nerve block injection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive the RELAY device for local anesthetic delivery and neuromodulation following shoulder or foot surgery

7 days

1 visit (in-person) for device insertion

Follow-up

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

14 days

2 visits (virtual) for follow-up assessments

Device Removal

Participants or their caretakers remove the RELAY device at home after 7 days

1 day

Treatment Details

Interventions

• RELAY system

Trial Overview The RELAY system is being tested for its ability to deliver both local anesthesia and electric current via one device after foot or shoulder surgery. This study aims to optimize the use of this device over the first week post-surgery and train clinical investigators.

Participant Groups

Group I: Experimental Treatment Experimental Treatment 1 Intervention

RELAY catheter will be inserted under ultrasound guidance followed by a local anesthetic bolus injection. If a patient's surgeon requests a postoperative continuous peripheral nerve block, a ropivacaine 0.2% infusion will be initiated in the recovery room. Within the recovery room, the stimulators will be connected to participants' phones and turned on. The catheters will be removed on postoperative day 7.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Gate Science

Industry Sponsor

Trials

1

Recruited

20+

Findings from Research

Epidural analgesia is more effective than systemic analgesia in managing postoperative pain, leading to benefits like earlier ambulation and hospital discharge.

Spinal opioids and various neural blockade techniques, such as intercostal nerve block, can significantly reduce postoperative pain and narcotic use, improving recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. Lutz, LJ., Lamer, TJ.[2019]

References

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

The impact of technology on the analgesic gap and quality of acute pain management. [2019]

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

Effects of a structured educational programme on patient-controlled analgesia (PCA) for gynaecological patients in South Korea. [2012]

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

Control of postoperative pain by interactive demand analgesia. [2019]

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

Electronic and disposable patient-controlled analgesia systems. A comparison of the Graseby and Baxter systems after major gynaecological surgery. [2019]

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

The traditional method of oral as-needed pain medication delivery compared to an oral patient-controlled analgesia device following total knee arthroplasty. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Management of postoperative pain: review of current techniques and methods. [2019]

7. France pubmed.ncbi.nlm.nih.gov

[Current trends of postoperative analgesia]. [2006]

8. England pubmed.ncbi.nlm.nih.gov

Treatment of pain after head and neck surgeries: control of acute pain after head and neck oncological surgeries. [2014]

9. Spain pubmed.ncbi.nlm.nih.gov

[Administration of lysine acetylsalicylate and meperidine in acute postoperative pain]. [2016]

10. Pakistan pubmed.ncbi.nlm.nih.gov

Effectiveness of acetaminophen in control of breakthrough pain: Randomized controlled trial. [2019]