Sustained Release Lidocaine for Postoperative Pain

Recruiting at 2 trial locations

Overseen By Graeme Boniface

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of British Columbia

Must not be taking: Antiarrhythmics, Anticoagulants

Disqualifiers: Chronic pain, Allergic reactions, 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 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of lidocaine, called ST-01, to determine if it can better manage pain after surgeries like circumcision or hemorrhoid removal. ST-01 is designed for slow release, potentially providing pain relief for several days post-surgery. Participants will receive either the new ST-01 treatment or the standard lidocaine or bupivacaine injection. Individuals who have undergone surgeries involving pelvic incisions and do not have chronic pain or allergies to lidocaine may be suitable for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lidocaine is usually well-tolerated for managing pain. Studies have found that lidocaine can ease pain after surgery without causing major side effects. For instance, one review highlighted that lidocaine patches can reduce pain after surgery without significant problems. Additionally, other research has shown that lidocaine infusions are safe and effective for managing sudden pain after surgeries.

ST-01 is a new version of lidocaine that releases the medication slowly over time. It is designed to provide pain relief for several days, which could benefit people undergoing surgery. Although ST-01 is new, it builds on the existing safety record of lidocaine, which is already widely and safely used in other forms. This suggests that ST-01 will likely be safe as well. However, since researchers are still testing ST-01, they continue to collect specific safety information about it. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care, which uses lidocaine or bupivacaine injections, ST-01 offers a sustained release formulation for postoperative pain. This innovative delivery method means ST-01 can provide ongoing pain relief from a single dose, potentially reducing the need for additional medication. Researchers are excited because this could simplify pain management after surgery, offering a more convenient and possibly more effective option for patients.

What evidence suggests that this treatment might be an effective treatment for postoperative pain?

Research has shown that lidocaine effectively manages post-surgery pain. A study that combined results from multiple trials found that lidocaine patches can reduce pain without causing side effects. Lidocaine also decreases the need for opioids (strong painkillers) and aids recovery, although its effect on reducing opioid use can vary. In this trial, participants will receive either the standard treatment of Lidocaine Hydrochloride Injection or Bupivacaine Hydrochloride Injection, or the new version, ST-01, which is designed to release lidocaine slowly. ST-01 aims to offer extended pain management after surgery and might provide longer-lasting pain relief. ^{2 3 6 7 8}

Who Is on the Research Team?

Graeme Boniface, PhD

Principal Investigator

Sustained Therapeutics Inc.

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine HCl Injection USP Xylocaine® or Bupivacaine HCl Injection USP Marcaine®
• ST-01

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

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

Approved in European Union as Lignocaine for:

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

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+

Sustained Therapeutics Inc.

Industry Sponsor

Trials

2

Recruited

180+

Published Research Related to This Trial

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]

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]

Lignocaine is effective as a local anaesthetic and antiarrhythmic drug, but its efficacy in preventing primary ventricular fibrillation during acute myocardial infarction is still debated, highlighting the need for careful monitoring of blood concentrations to avoid toxicity.

The pharmacokinetics of lignocaine can vary widely among patients, especially in those with cardiac failure or liver disease, necessitating individualized dosing strategies to ensure safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacokinetics of lignocaine. Benowitz, NL., Meister, W.[2022]

In a study involving 44 children aged 4 to 10, lignocaine gel was found to have lower pain scores compared to benzocaine gel when used as a topical anesthetic before local anesthesia, although the differences were not statistically significant.

Both lignocaine and benzocaine were equally effective as topical anesthetics, but children preferred the taste of lignocaine over benzocaine.

NCBI (Pubmed)

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. Kotian, N., Mani, G., Ramakrishnan, M.[2022]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10863528/

Efficacy of intraoperative systemic lidocaine on quality ... Compared with saline, systemic lidocaine improved the Quality of Recovery-15 score 24 h postoperatively, with a median difference of 4 (95% ...

2. prnewswire.com prnewswire.com/news-releases/postoperative-ileus-market-to-advance-moderately-during-the-forecast-period-20252034-owing-to-the-launch-of-novel-therapies--delveinsight-302597833.html

Postoperative Ileus Market to Advance Moderately During ... Intravenous lidocaine can reduce opioid dependence and may serve as an adjunct to promote bowel recovery. With no active branded therapies ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10399934/

Is Lidocaine Patch Beneficial for Postoperative Pain? A Meta ... The most recent meta-analysis showed that lidocaine patches could lower postoperative pain without side effects, but their morphine-sparing effect remains ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05072314

Long-term Outcomes of Lidocaine Infusions for Post- ... The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818021000611

Efficacy of systemic lidocaine on postoperative quality ... Systemic lidocaine fails to reduce opioid consumption, improve postoperative analgesia, and enhance quality of recovery in patients undergoing video-assisted ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27199310/

a systematic review with trial sequential analysis Meta-analysis suggested that lidocaine reduced postoperative pain (visual analogue scale, 0 to 10 cm) at 1-4 h (MD -0.84, 95% CI -1.10 to -0.59) and at 24 h (MD ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06725485

Low-Dose Lidocaine Infusion for Acute Pain Management ... The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0952818022002768

The effect of lidocaine patch for postoperative pain: A meta- ... LP can lower postoperative pain without side effects, compared to placebo or no patch. However, its morphine-sparing effect remains unclear.