Lidocaine Infusion for Postthoracotomy Pain Syndrome (LIPPS)

November 5, 2018 updated by: Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Recruiting
        • Guangzhou First People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lidocaine
Lidocaine treatment
Drug: Lidocaine
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Other Names:
  • intravenous lidocaine infusion
PLACEBO_COMPARATOR: Control
Placebo treatment
Drug: Control
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
Other Names:
  • normal saline control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of chronic pain
Time Frame: At 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.
At 3 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative acute pain
Time Frame: postoperative days 1 and 2.
Use numeric rating scale (NRS) to assess the postoperative acute pain
postoperative days 1 and 2.
Sedation
Time Frame: postoperative days 1 and 2.
Use numeric rating scale (NRS) to asses
postoperative days 1 and 2.
Postoperative nausea and vomiting (PONV) nausea
Time Frame: postoperative days 1 and 2.
Use numeric rating scale (NRS) to assess
postoperative days 1 and 2.
Fatigue
Time Frame: postoperative days 1 and 2.
Use numeric rating scale (NRS) to assess
postoperative days 1 and 2.
Occurrence of chronic pain at 6-month
Time Frame: At 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.
At 6 months after surgery.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postthoracotomy ipsilateral shoulder pain
Time Frame: postoperative days 1 and 2.
Use numeric rating scale (NRS) to assess
postoperative days 1 and 2.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou First People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 6, 2018

Primary Completion (ANTICIPATED)

June 30, 2019

Study Completion (ANTICIPATED)

June 30, 2019

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 9, 2018

First Posted (ACTUAL)

September 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZFPH-2018-114

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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