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This study seeks to investigate lidocaine infusion to reduce postthoractomy pain syndrome after thoracic Surgery
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Lidocaine treatment |
|
| Control | Placebo Comparator | Placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative acute pain | Use numeric rating scale (NRS) to assess the postoperative acute pain | postoperative days 1 and 2. |
| Sedation | Use numeric rating scale (NRS) to asses |
| Measure | Description | Time Frame |
|---|---|---|
| Postthoracotomy ipsilateral shoulder pain | Use numeric rating scale (NRS) to assess | postoperative days 1 and 2. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiangcai Ruan, PhD | Contact | +8620-81048306 | xc_ruan@hotmail.com | |
| Danyang Pan, MD | Contact | +86-13246886285 | Pandy0505@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiangcai Ruan, PhD | Affliated First People's Hospital of Guangzhou ,Guangzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | 510180 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28115872 | Background | 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. | |
| 25670347 | Background | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Control | Drug | Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery. |
|
|
| postoperative days 1 and 2. |
| Postoperative nausea and vomiting (PONV) nausea | Use numeric rating scale (NRS) to assess | postoperative days 1 and 2. |
| Fatigue | Use numeric rating scale (NRS) to assess | 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. | At 6 months after surgery. |
| 25899956 | Background | 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. |
| 26184397 | Background | 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. |
| 29757886 | Background | 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. |
| 24447497 | Background | 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. |
| 21145244 | Background | 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. |
| 20207481 | Background | 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. |
| 28691269 | Background | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |