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Lidocaine Infusion for Postthoracotomy Pain Syndrome

Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03666299
Acronym
LIPPS
Enrollment
72
Registered
2018-09-11
Start date
2018-11-06
Completion date
2019-06-30
Last updated
2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Lidocaine, Pain, Postoperative, Thoracic Surgery, Video-Assisted

Keywords

postthoracotomy pain syndrome, chronic pain, lidocaine

Brief summary

This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery

Detailed description

Postthoracotomy pain syndrome (PPS) is defined as a persistent and/or recurrent pain or burning sensation along the thoracotomy scar at 3 months after surgery. The pain is very significant, given that 3 to 5% of postthoractomy patients report it as being severe, and approximately 50% of patients report limitations in their activities of daily living. Little is known about the origin of this pain, but it seems that the intensity of acute postoperative pain is the best predictor of it. Lidocaine infusion could be a possible approach to reducing the prevalence of PPS. Recently, a meta-analysis concluded a modest but statistically significant reduction of pain severity in the first four postoperative hours measured by the visual analogue scale (mean difference, -0.84; 95% CI, -1.10 to -0.59). However, a more recent meta-analysis found that only limited clinical data and biological plausibility support lidocaine infusions for the prevention of postoperative persistent pain (odds ratio, 0.29; 95% CI, 0.18 to 0.48). This study was designed to investigate whether lidocaine infusion after video-assisted thoracoscopic surgery (VATS) would lower PPS at postoperative 3 and 6 month.

Interventions

DRUGLidocaine

Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.

DRUGControl

Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.

Sponsors

Guangzhou First People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases

Exclusion criteria

* (1)ASA classification status III or above * (2)Body weight\<35kg * (3)Liver cirrhosis * (4)A history of previous thoracotomy * (5)Pregnancy * (6)Severe arrhythmia * (7)Congestive heart failure * (8)Opioid or steroid use 6 months before surgery * (9)Allergy to lidocaine * (10)Chronic pain syndrome (any type) * (11)Emergency surgery * (12)Incapacity to give an informed consent, Visual dysfunction or severe mental disorders

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of chronic painAt 3 months after surgery.Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.

Secondary

MeasureTime frameDescription
Postoperative acute painpostoperative days 1 and 2.Use numeric rating scale (NRS) to assess the postoperative acute pain
Sedationpostoperative days 1 and 2.Use numeric rating scale (NRS) to asses
Fatiguepostoperative days 1 and 2.Use numeric rating scale (NRS) to assess
Occurrence of chronic pain at 6-monthAt 6 months after surgery.Chronic pain was assessed in accordance with the IMMPACT recommends in the domains of: (1) absence or presence of pain in the area of the surgery, (2) clinically important (NRS ≥ 4 on a 0- to 10-point scale) daily average pain, (3) clinically important pain at rest, (4) clinically important pain intensity upon movement or activity, (5) pain qualities, and (6) physical and emotional functioning.
Postoperative nausea and vomiting (PONV) nauseapostoperative days 1 and 2.Use numeric rating scale (NRS) to assess

Other

MeasureTime frameDescription
Postthoracotomy ipsilateral shoulder painpostoperative days 1 and 2.Use numeric rating scale (NRS) to assess

Countries

China

Contacts

Primary ContactXiangcai Ruan, PhD
xc_ruan@hotmail.com+8620-81048306
Backup ContactDanyang Pan, MD
Pandy0505@163.com+86-13246886285

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026