Lidocaine Infusion for Postthoracotomy Pain Syndrome

Chronic Pain Clinical Trial

— LIPPS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03666299
• Other study ID #: GZFPH-2018-114
• Status: Recruiting
• Phase: N/A
• Start date: November 6, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: November 2018
• Source: Guangzhou First People's Hospital
• Contact: Xiangcai Ruan, PhD
• Phone: +8620-81048306
• Email: xc_ruan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Lidocaine
Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
• Control
Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou First People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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, Kalliomäki 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):177-93. doi: 10.1016/j.pain.2010.02.018. Epub 2010 Mar 6. Review. — View Citation

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. — View Citation

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. Review. Update in: Cochrane Database Syst Rev. 2018 Jun 04;6:CD009642. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postthoracotomy ipsilateral shoulder pain	Use numeric rating scale (NRS) to assess	postoperative days 1 and 2.
Primary	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.	At 3 months after surgery.
Secondary	Postoperative acute pain	Use numeric rating scale (NRS) to assess the postoperative acute pain	postoperative days 1 and 2.
Secondary	Sedation	Use numeric rating scale (NRS) to asses	postoperative days 1 and 2.
Secondary	Postoperative nausea and vomiting (PONV) nausea	Use numeric rating scale (NRS) to assess	postoperative days 1 and 2.
Secondary	Fatigue	Use numeric rating scale (NRS) to assess	postoperative days 1 and 2.
Secondary	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.	At 6 months after surgery.