Sustained Release Lidocaine for Postoperative Pain

Recruiting at2 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of British Columbia

Must not be taking: Antiarrhythmics, Anticoagulants

Disqualifiers: Chronic pain, Allergic reactions, others

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new slow-release lidocaine formulation (ST-01) to manage pain after certain surgeries. It aims to provide longer-lasting pain relief and reduce the need for opioids. The medication is injected near the surgical site and releases lidocaine over time. Lidocaine has been used in various forms for pain management, including topical systems and systemic infusions, to reduce pain and opioid consumption.

Will I have to stop taking my current medications?

You may need to stop taking certain medications, especially if they are on the prohibited list like some heart medications. The trial does not specify a washout period, but it's important to discuss your current medications with the study team.

What data supports the effectiveness of the drug for postoperative pain?

Research shows that lidocaine, when used as an infusion, can help reduce chronic postsurgical pain and is considered safe, although more studies are needed to confirm its safety and effectiveness. Additionally, lidocaine patches have been found to be beneficial for managing postoperative pain as part of a multimodal pain relief approach. ^{1 2 3 4 5}

Is sustained release lidocaine generally safe for humans?

Lidocaine, also known as lignocaine, is widely used as a local anesthetic and is generally considered safe when used correctly. However, toxicity can occur, especially with overdosage, and is related to blood concentrations of the drug. Intravenous lidocaine has been used safely for postoperative pain and chronic pain management, but care must be taken with dosing, particularly in patients with liver or heart conditions. ^{1 2 4 6 7}

How is the drug ST-01 different from other treatments for postoperative pain?

ST-01 is unique because it uses sustained-release lidocaine particles, which provide prolonged pain relief without the need for continuous administration or catheters, unlike traditional methods that may require repeated dosing or invasive procedures. ^{8 9 10 11 12}

Research Team

Graeme Boniface, PhD

Principal Investigator

Sustained Therapeutics Inc.

Eligibility Criteria

This trial is for adults aged 19 or older who need surgery involving pelvic, perineal, or perianal incisions and can consent to study procedures. Participants must be willing to use birth control if sexually active. Those with allergies to lidocaine, heart issues, on certain medications (like antiarrhythmics), or with chronic pain conditions using opioids are excluded.

Inclusion Criteria

Able and willing to provide informed consent

If sexually active, is willing to use adequate birth control methods to prevent pregnancy over the course of the study

I am 19 years old or older.

Exclusion Criteria

I don't have any health conditions that would make it unsafe for me to join.

Has participated in another clinical trial within 3 months prior to the Screening Visit or is planning to participate in another clinical trial during this trial period

I am not allergic to lidocaine or certain heart and blood thinning medications.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ST-01 or standard of care after surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants report their postsurgical pain and analgesic medication taken

3 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Treatment Details

Interventions

• Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl Injection USP Marcaine® (Local Anesthetic)
• ST-01 (Local Anesthetic)

Trial Overview The study is testing a new sustained release form of lidocaine called ST-01 against standard injections like Xylocaine® or Marcaine® for managing postoperative pain after specific surgeries. The goal is to see if ST-01 provides longer-lasting pain relief.

Participant Groups

Group I: Treatment (ST-01) Experimental Treatment 1 Intervention

Administration of ST-01 as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

Group II: Control (Standard of Care) Active Control 1 Intervention

Administration of Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®) as single-dose into the cutaneous, subcutaneous and fascia region of the surgical site and/or as nerve block.

ST-01 is already approved in Canada for the following indications:

Approved in Canada as Lidocaine for:

• Local anesthesia
• Ventricular tachycardia
• Ventricular fibrillation
• Chronic pain
• Acute surgical pain

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Dr. Christopher Haqq

University of British Columbia

Chief Medical Officer since 2019

MD, University of British Columbia

Bekki Bracken Brown

University of British Columbia

Chief Executive Officer since 2023

Bachelor's degree from Duke University

Sustained Therapeutics Inc.

Industry Sponsor

Trials

2

Recruited

180+

Findings from Research

Intravenous lignocaine infusion is a safe and effective method for postoperative pain management in Chinese patients undergoing laparoscopic colorectal surgery, with low pain scores reported post-surgery.

The use of lignocaine significantly enhances recovery, as evidenced by the absence of postoperative ileus and improved times for bowel function recovery and hospital stay, with patients reporting high satisfaction scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous lignocaine infusion facilitates acute rehabilitation after laparoscopic colectomy in the Chinese patients. Lee, MW., Or, DY., Tsang, AC., et al.[2018]

Perioperative lidocaine infusions significantly reduce the incidence of chronic postsurgical pain (CPSP) by 71% compared to placebo, based on a systematic review of 6 trials involving 420 participants.

While lidocaine appears effective in preventing CPSP, the intensity of pain reduction was not statistically significant, and there were no reported adverse events, highlighting the need for more comprehensive safety assessments in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Bailey, M., Corcoran, T., Schug, S., et al.[2021]

A retrospective review of 233 chronic pain patients indicated that intravenous lidocaine infusions are generally safe, with mild and transient side effects like tingling and dizziness, primarily occurring during the initial infusion.

About 41% of patients experienced long-lasting pain relief, particularly those who responded positively to the first infusion, suggesting that lidocaine could be an effective long-term treatment option for chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tertiary Care Clinical Experience with Intravenous Lidocaine Infusions for the Treatment of Chronic Pain. Iacob, E., Hagn, EE., Sindt, J., et al.[2019]

Lidocaine patches significantly reduce postoperative pain scores at 12, 24, and 48 hours after surgery, indicating their effectiveness as part of multimodal analgesia, based on a meta-analysis of 16 trials involving 918 patients.

The use of lidocaine patches also leads to a decrease in opioid consumption, suggesting they can help manage pain while potentially reducing reliance on stronger pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Lidocaine Patch Beneficial for Postoperative Pain?: A Meta-analysis of Randomized Clinical Trials. Wu, X., Wei, X., Jiang, L., et al.[2023]

Articaine, introduced in 1976 and widely used since 1986, has become the most popular local anesthetic in dentistry, surpassing lignocaine due to its effective pain control and rapid action.

Compared to older anesthetics, articaine offers enhanced safety and efficacy, making it a valuable addition to the local anesthetic options available to dental practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New anesthetics]. Malamed, SF.[2013]

Sustained-release lidocaine particles (SRLPs) provided effective pain relief for up to 7 days in a rat model of postoperative pain without causing significant motor paralysis or major complications.

The SRLP-10 formulation, which released lidocaine over 7 days, was particularly effective in reducing hypersensitivity, while the SRLP-25 formulation showed temporary motor paralysis but still inhibited pain for the same duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effect of epidural injection with sustained-release lidocaine particles in a rat model of postoperative pain. Suto, T., Obata, H., Tobe, M., et al.[2018]

The 5% lidocaine medicated plaster is effective for treating localized neuropathic pain, particularly in conditions like postherpetic neuralgia and painful diabetic polyneuropathy, showing comparable efficacy to systemic pregabalin.

The lidocaine plaster is generally well tolerated with minimal risk of systemic side effects, making it a safe option for long-term treatment of various neuropathic pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical pain management with the 5% lidocaine medicated plaster--a review. Mick, G., Correa-Illanes, G.[2019]

In a retrospective study of 101 patients with localized neuropathic pain, 5% lidocaine medicated plaster (LMP) resulted in a significant 64% reduction in pain intensity after an average treatment duration of 41 days, demonstrating its efficacy for conditions like postherpetic neuralgia.

LMP was well-tolerated with minimal adverse effects, leading to treatment discontinuation in only three cases, supporting its safety as a first-line treatment option for localized peripheral neuropathic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Experience with 5% lidocaine medicated plaster in the treatment of localized neuropathic pain]. Fogliardi, A., Brunori, C.[2013]

In a long-term study of 20 patients with localized neuropathic pain, 50% continued to experience effective pain relief after 3 years of using the 5% lidocaine medicated plaster, with 40% still benefiting after 5 years.

The treatment was well tolerated, with no patients discontinuing due to inadequate pain relief or intolerable side effects, and only minor reversible skin reactions were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term treatment of neuropathic pain with a 5% lidocaine medicated plaster. Wilhelm, IR., Tzabazis, A., Likar, R., et al.[2013]

The sustained-release lidocaine sheet (SRLS) demonstrated safety and potential for pain relief after tooth extraction in a study involving 99 patients, with no serious side effects reported.

Despite testing various doses of SRLS (100 mg, 200 mg, and 400 mg), there were no significant differences in pain intensity or patient satisfaction among the groups, suggesting that 100 mg may be an effective dose for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained-release lidocaine sheet for pain following tooth extraction: A randomized, single-blind, dose-response, controlled, clinical study of efficacy and safety. Suzuki, T., Kosugi, K., Suto, T., et al.[2019]

References

1. China pubmed.ncbi.nlm.nih.gov

Intravenous lignocaine infusion facilitates acute rehabilitation after laparoscopic colectomy in the Chinese patients. [2018]

2. India pubmed.ncbi.nlm.nih.gov

Comparative Evaluation of Two Different Topical Anesthetic Agents in Controlling Pain during Intraoral Local Anesthetic Administration in Children: A Split-mouth Triple-blinded Randomized Clinical Trial. [2022]

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

Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. [2021]

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

Tertiary Care Clinical Experience with Intravenous Lidocaine Infusions for the Treatment of Chronic Pain. [2019]

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

Is Lidocaine Patch Beneficial for Postoperative Pain?: A Meta-analysis of Randomized Clinical Trials. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of lignocaine. [2022]

7. Belgium pubmed.ncbi.nlm.nih.gov

[New anesthetics]. [2013]

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

Long-term effect of epidural injection with sustained-release lidocaine particles in a rat model of postoperative pain. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Topical pain management with the 5% lidocaine medicated plaster--a review. [2019]

10. Italy pubmed.ncbi.nlm.nih.gov

[Experience with 5% lidocaine medicated plaster in the treatment of localized neuropathic pain]. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Long-term treatment of neuropathic pain with a 5% lidocaine medicated plaster. [2013]

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

Sustained-release lidocaine sheet for pain following tooth extraction: A randomized, single-blind, dose-response, controlled, clinical study of efficacy and safety. [2019]