Thoracic Surgery, Video-AssistedLIPPSNCT03666299
Lidocaine Infusion for Postthoracotomy Pain Syndrome
A study testing Lidocaine in people with Thoracic Surgery, Video-Assisted and Lidocaine, run by Guangzhou First People's Hospital at 1 site in China.
Trial summary
This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracic Surgery, Video-Assisted, Lidocaine, Pain, Postoperative
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases
Who cannot join
- (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
Show all 12Show fewer
- (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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Yu Luo, MD, 020-81045412, MEC_GZSY@163.com
About this study
Official title: 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
Read the 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.
- Being tested
- Lidocaine, Control
- Keywords
- postthoracotomy pain syndrome, chronic pain, lidocaine
- Medical subject headings
- Pain, Postoperative, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called intravenous lidocaine infusion
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
ControlDrug
Also called normal saline control
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Lidocaine treatment Receives: Drug: Lidocaine |
| Control | Placebo comparator | Placebo treatment Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of chronic pain
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.
Measured: At 3 months after surgery.
Secondary outcomes (5)
Postoperative acute pain
Use numeric rating scale (NRS) to assess the postoperative acute pain
Measured: postoperative days 1 and 2.
Sedation
Use numeric rating scale (NRS) to asses
Measured: postoperative days 1 and 2.
Postoperative nausea and vomiting (PONV) nausea
Use numeric rating scale (NRS) to assess
Measured: postoperative days 1 and 2.
Fatigue
Use numeric rating scale (NRS) to assess
Measured: postoperative days 1 and 2.
Occurrence of chronic pain at 6-month
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.
Measured: At 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start6 Nov 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Thoracic Surgery, Video-AssistedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou First People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain, Guangzhou First People's Hospital
- Investigators
- Xiangcai Ruan, PhD, Principal investigator, Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666299
- Sponsor's protocol ID
- GZFPH-2018-114
- Acronym
- LIPPS
- Status last verified
- Nov 2018
- First submitted
- 9 Sep 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang JL, Zhang WJ, Gao M, Zhang S, Tian DH, Chen J. A cross-cultural adaptation and validation of the short-form McGill Pain Questionnaire-2: Chinese version in patients with chronic visceral pain. J Pain Res. 2017 Jan 5;10:121-128. doi: 10.2147/JPR.S116997. eCollection 2017.
PubMed 28115872Slovack M, Taylor B, Bryce R, Ong D. Does intravenous lidocaine infusion during video-assisted thoracoscopic surgery reduce postoperative analgesia? A randomized controlled study. Can J Anaesth. 2015 Jun;62(6):676-7. doi: 10.1007/s12630-015-0333-z. Epub 2015 Feb 11. No abstract available.
PubMed 25670347Brulotte V, Ruel MM, Lafontaine E, Chouinard P, Girard F. Impact of pregabalin on the occurrence of postthoracotomy pain syndrome: a randomized trial. Reg Anesth Pain Med. 2015 May-Jun;40(3):262-9. doi: 10.1097/AAP.0000000000000241.
PubMed 25899956Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
PubMed 26184397Bailey M, Corcoran T, Schug S, Toner A. Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Pain. 2018 Sep;159(9):1696-1704. doi: 10.1097/j.pain.0000000000001273.
PubMed 29757886Bunchungmongkol N, Pipanmekaporn T, Paiboonworachat S, Saeteng S, Tantraworasin A. Incidence and risk factors associated with ipsilateral shoulder pain after thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):979-82. doi: 10.1053/j.jvca.2013.10.008. Epub 2014 Jan 18.
PubMed 24447497Martinez-Barenys C, Busquets J, de Castro PE, Garcia-Guasch R, Perez J, Fernandez E, Mesa MA, Astudillo J. Randomized double-blind comparison of phrenic nerve infiltration and suprascapular nerve block for ipsilateral shoulder pain after thoracic surgery. Eur J Cardiothorac Surg. 2011 Jul;40(1):106-12. doi: 10.1016/j.ejcts.2010.10.025. Epub 2010 Dec 8.
PubMed 21145244Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomaki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010 May;149(2):177-193. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.
PubMed 20207481Kendall MC, McCarthy RJ, Panaro S, Goodwin E, Bialek JM, Nader A, De Oliveira GS Jr. The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Pract. 2018 Mar;18(3):350-359. doi: 10.1111/papr.12611. Epub 2017 Sep 13.
PubMed 28691269
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lidocaine Infusion for Postthoracotomy Pain Syndrome, A Prospective, Randomized, Double-blind, Placebo-controlled Trial (LIPPS Trial)
- ClinicalTrials.gov ID
- NCT03666299
- Acronym / sponsor ID
- LIPPS / GZFPH-2018-114
- Keywords
- postthoracotomy pain syndrome, chronic pain, lidocaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Guangzhou First People's HospitalUniversity, hospital or other
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 11 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineLidocaine treatment |
| Control | Placebo comparator | Drug: ControlPlacebo treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled to undergo a muscle-sparing lateral minithoracotomy for different thoracic diseases
Key exclusion criteria (12 listed)
- (1)ASA classification status III or above
- (2)Body weight<35kg
- (3)Liver cirrhosis
- (4)A history of previous thoracotomy
- (5)Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: intravenous lidocaine infusionInfusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery. | Drug | Lidocaine |
| ControlAlso: normal saline controlInfusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery. | Drug | Control |
Primary outcome
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.
5 secondary outcomes
Postoperative acute pain
Time frame: postoperative days 1 and 2.
Sedation
Time frame: postoperative days 1 and 2.
Postoperative nausea and vomiting (PONV) nausea
Time frame: postoperative days 1 and 2.
Fatigue
Time frame: postoperative days 1 and 2.
Occurrence of chronic pain at 6-month
Time frame: At 6 months after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
- Background: PubMed 28115872Wang JL, Zhang WJ, Gao M, Zhang S, Tian DH, Chen J. A cross-cultural adaptation and validation of the short-form McGill Pain Questionnaire-2: Chinese version in patients with chronic visceral pain. J Pain Res. 2017 Jan 5;10:121-128. doi: 10.2147/JPR.S116997. eCollection 2017.
- Background: PubMed 25670347Slovack M, Taylor B, Bryce R, Ong D. Does intravenous lidocaine infusion during video-assisted thoracoscopic surgery reduce postoperative analgesia? A randomized controlled study. Can J Anaesth. 2015 Jun;62(6):676-7. doi: 10.1007/s12630-015-0333-z. Epub 2015 Feb 11. No abstract available.
- Background: PubMed 25899956Brulotte V, Ruel MM, Lafontaine E, Chouinard P, Girard F. Impact of pregabalin on the occurrence of postthoracotomy pain syndrome: a randomized trial. Reg Anesth Pain Med. 2015 May-Jun;40(3):262-9. doi: 10.1097/AAP.0000000000000241.
- Background: PubMed 26184397Kranke P, Jokinen J, Pace NL, Schnabel A, Hollmann MW, Hahnenkamp K, Eberhart LH, Poepping DM, Weibel S. Continuous intravenous perioperative lidocaine infusion for postoperative pain and recovery. Cochrane Database Syst Rev. 2015 Jul 16;(7):CD009642. doi: 10.1002/14651858.CD009642.pub2.
- Background: PubMed 29757886Bailey M, Corcoran T, Schug S, Toner A. Perioperative lidocaine infusions for the prevention of chronic postsurgical pain: a systematic review and meta-analysis of efficacy and safety. Pain. 2018 Sep;159(9):1696-1704. doi: 10.1097/j.pain.0000000000001273.
- Background: PubMed 24447497Bunchungmongkol N, Pipanmekaporn T, Paiboonworachat S, Saeteng S, Tantraworasin A. Incidence and risk factors associated with ipsilateral shoulder pain after thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):979-82. doi: 10.1053/j.jvca.2013.10.008. Epub 2014 Jan 18.
- Background: PubMed 21145244Martinez-Barenys C, Busquets J, de Castro PE, Garcia-Guasch R, Perez J, Fernandez E, Mesa MA, Astudillo J. Randomized double-blind comparison of phrenic nerve infiltration and suprascapular nerve block for ipsilateral shoulder pain after thoracic surgery. Eur J Cardiothorac Surg. 2011 Jul;40(1):106-12. doi: 10.1016/j.ejcts.2010.10.025. Epub 2010 Dec 8.
- Background: PubMed 20207481Dworkin RH, Turk DC, Peirce-Sandner S, Baron R, Bellamy N, Burke LB, Chappell A, Chartier K, Cleeland CS, Costello A, Cowan P, Dimitrova R, Ellenberg S, Farrar JT, French JA, Gilron I, Hertz S, Jadad AR, Jay GW, Kalliomaki J, Katz NP, Kerns RD, Manning DC, McDermott MP, McGrath PJ, Narayana A, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Reeve BB, Rhodes T, Sampaio C, Simpson DM, Stauffer JW, Stucki G, Tobias J, White RE, Witter J. Research design considerations for confirmatory chronic pain clinical trials: IMMPACT recommendations. Pain. 2010 May;149(2):177-193. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6.
- Background: PubMed 28691269Kendall MC, McCarthy RJ, Panaro S, Goodwin E, Bialek JM, Nader A, De Oliveira GS Jr. The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. Pain Pract. 2018 Mar;18(3):350-359. doi: 10.1111/papr.12611. Epub 2017 Sep 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiangcai Ruan, PhD principal investigator
Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Thoracic Surgery, Video-Assisted and Lidocaine, run by Guangzhou First People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangcai Ruan, PhD (+8620-81048306, xc_ruan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of chronic pain (time frame: At 3 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03666299, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018.