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

PHASE3RECRUITING

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.

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Study details:

The Trial's purpose is to evaluate the effectiveness of lidocaine infusions commenced during surgery and extending up to 24 hours postoperatively, on the incidence of moderate or severe chronic post-surgical pain (CPSP) detected one year following surgery in female patients undergoing elective breast cancer surgery. The trial has 90% power to detect a clinically meaningful (25%) reduction in the incidence of the primary outcome. Secondary outcomes include safety events, analgesic efficacy (pain scores and opioid consumption), neuropathic characteristics of CPSP, and psychological and quality of life outcomes.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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 breast cancer under general anaesthesia (including those with simultaneous insertion of tissue expanders or implants).

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

Exclusion criteria

Pre-existing pain at site of surgery, axilla, ipsilateral side of chest wall or the ipsilateral upper arm

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

When immediate autologous reconstruction surgery is planned

Where delayed autologous reconstruction surgery on the operative breast within one year is planned

Planned use of regional analgesia infusions

Impaired cognition

Pregnant or lactating females

Transgender patients

Known metastatic disease

History of anaphylaxis, sensitivity or known contraindication to lidocaine (or other amide local anaesthetic agents e.g. other amide local anaesthetic agents: ropivacaine, bupivacaine, mepivacaine, prilocaine, etidocaine), including patients with porphyria or methaemoglobinaemia

History of epilepsy

Baseline heart rate < 50 bpm or systolic blood pressure < 100mmHg.

Acute coronary event in the last three months

Cardiac conduction abnormalities, including; Atrial fibrillation, Heart block (all degrees), Bundle Branch Block or Fascicular block, Prolonged QT interval, Wolf Parkinson White syndrome, channelopathy such as Brugada syndrome. A preoperative Electrocardiogram (ECG) is not mandatory, unless clinically indicated

Abnormal serum potassium concentration (based upon site laboratory reference ranges)

Abnormal serum sodium concentration (based upon site laboratory reference ranges)

Active liver disease e.g. viral hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease, haemochromatosis, other rarer causes)

Medications within the last 7 days which are known / suspected to slow lidocaine metabolism (amiodarone, beta blockers, cimetidine, fluoroquinolones, fluvoxamine, imidazoles, macrolides, verapamil, HIV drugs)

Cardiac Failure (any documented heart failure at peroperative assessment or GP records)

Severe Renal Failure (Creatinine Clearance of less than 30ml/min or dialysis dependent)

Co-administration of lidocaine within 24 hours prior to surgery for other reasons (e.g. lidocaine patches

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2022-07-27

Primary completion: 2027-07-01

Study completion finish: 2028-07-01

Study type

PREVENTION

Phase

PHASE3

Trial ID

NCT05072314

Intervention or treatment

DRUG: lidocaine 2% and 10%

DRUG: Placebo

Conditions

• Breast Cancer
• Breast Cancer Female
• Breast Conserving Surgery
• Mastectomy

Condition: Breast Cancer, Breast Cancer Female and more
DRUG: lidocaine 2% and 10% and other drugs
Sydney, New South Wales, Australia and more
Sponsor: Monash University

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Prince of Wales Hospital

Research sites nearby

Select from list below to view details:

Prince of Wales Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia
Queen Elizabeth II Jubilee Hospital
Coopers Plains, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Lidocaine 2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.	DRUG: lidocaine 2% and 10% 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_COMPARATOR: Placebo 0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.	DRUG: Placebo 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

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Lidocaine

2% Lidocaine infusion intra-operative and 10% Lidocaine infusion post-operative.

DRUG: lidocaine 2% and 10%

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_COMPARATOR: Placebo

0.9% Saline infusion intra-operative and 0.9% Saline infusion post-operative.

DRUG: Placebo

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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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).	1 year post-surgery

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Severity of acute postoperative pain at rest	Maximum pain score, Numerical rating scale (NRS) 0-10	24 hours postoperatively
Severity of Acute postoperative pain on movement	Maximum pain score, Numerical rating scale (NRS) 0-10	24 hours postoperatively
Postoperative opioid consumption	Morphine Equivalent Opioid Consumption (MEQ)	on Day 1
Postoperative opioid consumption	Morphine Equivalent Opioid Consumption (MEQ)	3 months (last 24-hours)
The Incidence of moderate to severe Chronic Post Surgical Pain from radiation therapy	with a significant contribution from radiation therapy	1 year post surgery
The Incidence of moderate to severe Chronic Post Surgical Pain from repeat surgery	with a significant contribution from repeat surgery	1 year post surgery
The incidence of severe CPSP at 1 year after surgery	NRS for worst pain the in the last week of ≥7)	1 year post surgery
The incidence of mild or greater CPSP at 1 year after surgery	NRS for worst pain the in the last week of ≥1	1 year post surgery
The incidence of discomfort or altered sensation at the site of surgery (not reported as pain)	Patients asked if they have any altered sensation at the site of surgery	1 year post surgery
Severity of CPSP	Assessed using "average" and "worst" NRS pain score in the last week, obtained from the adapted modified Brief Pain Inventory-Short Form (mBPI-SF)	1 year post surgery
Incidence of neuropathic symptoms	Incidence examined as a binary outcome using the Short Form of Douleur Neuropathique 4 Questions (S-DN4)	1 year post surgery
Postoperative opioid consumption	Morphine Equivalent Opioid Consumption (MEQ)	1 year post surgery (last 24 hours)
Physical functioning	Using interference component of mBPI-SF	1 year post surgery
Changes in quality of life metrics EuroQol 5 Dimension 5 Level (EQ-5D-5L) at 1 year after surgery compared to baseline	Changes in the quality of life	1 year post surgery
Changes in psychological wellbeing Kessler Psychological Distress Scale (K-10) at 1 year after surgery compared to baseline.	Changes in psychological wellbeing	1 year post surgery
The incidence of mortality at 1 year	Mortality at 1 year	1 year post surgery
UK NHS costs of care over 1 year following surgery	UK/NHS sites only	1 year post surgery
Productivity costs over 1 year following surgery	UK/NHS sites only	1 year post surgery
Quality-adjusted life years (QALYs) over 1 year following surgery	UK/NHS sites only	1 year post surgery
Cost-effectiveness of perioperative lidocaine infusions compared to usual care, from a primary UK NHS perspective and broader perspective including productivity, at 1 year.	UK/NHS sites only	1 year post surgery

Frequently Asked Questions

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References

Clinical Trials Gov: Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial