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Sustained Release Lidocaine for the Treatment of Postoperative Pain

ConditionsPostoperative PainPostsurgical Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of British Columbia

About this trial

In this study, the investigators are testing a new formulation of lidocaine for its suitability in managing postoperative pain after pelvic (circumcision, inguinal, scrotal), perineal (hemorrhoidectomy) or perianal (fistulotomy) incisions. The new formulation ST-01 is a sustained release lidocaine formulation and is expected to provide pain relief over multiple days. Currently, the drug lidocaine is not available as an injectable slow-release formulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any sex, aged ≥ 19 years

Indication to undergo an operation with a planned pelvic incision

Able and willing to provide informed consent

Stated willingness to comply with all study procedures and availability for the duration of the study

Disqualifiers

History of chronic pain conditions associated with the use of opioids or steroids

Known allergic reactions to any components of the investigational product

Active infection involving the surgical site

Any contraindication to local anesthesia with lidocaine (e.g., known hypersensitivity to anesthetics of the amide type, known hypokalemia, complete heart block, anticoagulants (ASA permitted) antiarrhythmic medication)

Trial design

Design model

Parallel

Treatments tested in this trial

  • ST-01

    Drug

    Administration of up to 8 mL ST-01 (70 mg/mL lidocaine)

  • Control (Lidocaine Hydrochloride Injection USP Xylocaine® or Bupivacaine Hydrochloride Injection USP Marcaine®)

    Drug

    Administration of up to 3 mg/kg bupivacaine hydrochloride injection (0.25%) or up to 4.5mg/kg lidocaine hydrochloride injection (0.5-1%)

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Treatment (ST-01)Experimental treatment 1 intervention
Group B: Control (Standard of Care)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the efficacy of an injection of ST-01 to reduce subject-reported postoperative pain after surgery compared to standard of care

The mean area under the curve (AUC) of the visual analogue scale (VAS) of pain intensity scores through day 3 (AUC0-3) for ST-01 compared with standard of care (SOC).

Time frame
3 days

Secondary outcomes

1

To evaluate the safety of an injection of ST-01

The incidence of treatment-emergent adverse events (TEAEs) and TEAEs related to the study treatment

Time frame
30 days
2

To compare the intake of opioid analgesic medication by subjects after an injection of ST-01 or standard of care

The mean total postoperative opioid consumption through 3 days for ST-01 compared to SOC

Time frame
3 days
3

To compare the intake of non-opioid analgesic medication by subjects after an injection of ST-01 or standard of care

The mean total postoperative non-opioid consumption through 3 days for ST-01 compared to SOC

Time frame
3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Sustained Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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