Lidocaine Infusion for Postthoracotomy Pain Syndrome

NCT ID: NCT03666299

Last Updated: 2018-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-06
• Study Completion Date: 2019-06-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lidocaine

Lidocaine treatment

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

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

Control

Placebo treatment

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

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

Interventions

Lidocaine

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

Intervention Type: DRUG

Control

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

Intervention Type: DRUG

Other Intervention Names

intravenous lidocaine infusion; normal saline control

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou First People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiangcai Ruan, MD, PhD, Vice-Director in Dept Anesth & Pain

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiangcai Ruan, PhD

Role: PRINCIPAL_INVESTIGATOR

Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University

Locations

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangcai Ruan, PhD

Role: CONTACT

xc_ruan@hotmail.com

+8620-81048306

Danyang Pan, MD

Role: CONTACT

Pandy0505@163.com

+86-13246886285

Facility Contacts

Yu Luo, MD

Role: primary

MEC_GZSY@163.com

020-81045412

References

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.

Reference Type: BACKGROUND

PMID: 28115872 (View on PubMed)

Slovack 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.

Reference Type: BACKGROUND

PMID: 25670347 (View on PubMed)

Brulotte 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.

Reference Type: BACKGROUND

PMID: 25899956 (View on PubMed)

Kranke 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.

Reference Type: BACKGROUND

PMID: 26184397 (View on PubMed)

Bailey 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.

Reference Type: BACKGROUND

PMID: 29757886 (View on PubMed)

Bunchungmongkol 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.

Reference Type: BACKGROUND

PMID: 24447497 (View on PubMed)

Martinez-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.

Reference Type: BACKGROUND

PMID: 21145244 (View on PubMed)

Dworkin 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.

Reference Type: BACKGROUND

PMID: 20207481 (View on PubMed)

Kendall 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.

Reference Type: BACKGROUND

PMID: 28691269 (View on PubMed)

Other Identifiers

GZFPH-2018-114

Identifier Type: -

Identifier Source: org_study_id