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Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

ConditionsBreast CancerBreast Cancer FemaleBreast Conserving SurgeryMastectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMonash University

About this trial

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Consenting adult female patients (≥18 years) undergoing mastectomy (unilateral or bilateral) or breast conserving surgery (unilateral or bilateral) for the primary excision of confirmed or suspected primary breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants)*. * this specifically excludes patients undergoing surgery for locoregional recurrence

American Society of Anaesthesiologist (ASA) physical scale 1-3

Disqualifiers

Mastectomy or breast conserving surgery with add on procedures e.g laparoscopic salpingectomy

Where surgery is being performed for locoregional recurrence of breast cancer

Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm (at diagnosis prior to any tumor locating procedures)

Re-excision procedures where the margins at the index surgery have been deemed insufficient

Trial design

Design model

Parallel

Treatments tested in this trial

  • lidocaine 2% and 10%

    Drug

    Lidocaine infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 2% lidocaine (2.5 mg/kg).\* 2. Followed by a 2% lidocaine intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

  • Placebo

    Drug

    Placebo infusion: 1. Commencing with an intravenous bolus after induction of anaesthesia, 0.125 ml/kg of lean body weight (LBW) of 0.9% Saline solution.\* 2. Followed by a 0.9% Saline solution intravenous infusion for the duration of surgery, 0.1665 ml/kg/h of LBW (3.33 mg/kg/hr).\* 3. A post-operative subcutaneous 0.0222 ml/kg/hr of LBW 0.9% Saline solution infusion for up to 24 hours thereafter (2.22 mg/kg/hr). Dosage will be capped at a maximum lean body weight of 68kg. * \*Day-case surgery receives intraoperative bolus and intraoperative infusion only

Treatment groups

4,300 Participants
are divided into 2 treatment groups
Group A: LidocaineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of moderate or severe CPSP at 1 year after surgery, as reported by the patient at the follow-up review.

Numerical rating scale ≥4 out of 10 for worst pain in the last week - The pain must have been present for at least 3 months prior to the one year assessment (or longer).

Time frame
1 year post-surgery

Secondary outcomes

1

The incidence of severe CPSP at 1 year after surgery

NRS for worst pain the in the last week of ≥7)

Time frame
1 year post surgery
2

Severity of pain at the site of surgery

Assessed using "average" and "worst" NRS pain score in the last week, obtained from the adapted modified Brief Pain Inventory-Short Form (mBPI-SF)

Time frame
1 year post surgery
3

Incidence of neuropathic symptoms

Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4)

Time frame
1 year post surgery
4

Physical functioning

Using interference component of mBPI-SF

Time frame
1 year post surgery

Other outcomes

1

Incidence of treated bradycardia intraoperatively

Drug related safety Endpoints

Time frame
24 hours postoperatively
2

Incidence of treated hypotension intraoperatively

Drug related safety Endpoints

Time frame
24 hours postoperatively
3

Incidence of treated bradycardia in Post Anaesthesia Care Unit (PACU)

Drug related safety Endpoints

Time frame
24 hours postoperatively
4

Incidence of treated hypotension in Post Anaesthesia Care Unit (PACU)

Drug related safety Endpoints

Time frame
24 hours postoperatively

Sponsors and contacts

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

Monash University

Lead sponsor

Royal Perth Hospital

Collaborator

Source ClinicalTrials.gov
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