Use of a lidocaine patch in the management of postsurgical neuropathic pain in patients with cancer: a phase III double-blind crossover study (N01CB)
- First Online:
- 344 Downloads
Current therapies often have limited efficacy and untenable side effects when used to treat persistent incisional pain following cancer-related surgery. Lidocaine patches reduce neuropathic pain from herpes zoster but their benefits for persistent cancer-related postsurgical incisional pain remain unclear.
Multicenter, double-blind, randomized, two-period crossover trial.
Materials and methods
Twenty-eight cancer patients with postsurgical incisional pain were randomly assigned to receive either lidocaine patches followed by placebo patches or the reverse. Each study period lasted 4 weeks. Patches were applied daily upon waking and left in place for a maximum of 18 h. The primary outcome measure, an 11-point pain intensity rating scale, was administered weekly. Secondary outcomes were administered weekly (Brief Pain Inventory-Short Form(BPI-SF), Subject Global Impression of Change) and at the end of each study period (Short Form-Magill Pain Questionnaire, Linear Analogue Self Assessment Scale, Neuropathy Pain Scale, Pain Catastrophizing Scale, Profile of Mood States Short Form).
Twenty-one patients completed the first period and 18 completed their crossover second phase. No significant intergroup differences were detected in pain intensity ratings. Few secondary end points were significantly different when subjects used the lidocaine versus placebo patches. BPI-SF interference scores were lower in patients using the lidocaine patch during the first study period, including several scores that achieved statistical significance, general activity (p = 0.02), work (p = 0.04), and relations with others (p = 0.02).
Lidocaine patch use did not significantly reduce pain intensity ratings or the majority of related secondary end points in cancer patients with persistent incisional pain.
KeywordsLidocaine patch Postsurgical neuropathic pain Cancer Cancer-related pain
- 5.Cleeland C et al (1992) How to assess cancer pain. In: Turk DC, Melzack R (eds) Handbook of pain assessment. Guilford, New York, pp 360–387Google Scholar
- 9.Fairclough DPH, Cella D, Bonomi P (1998) Comparison of several model-based methods for analyzing incomplete quality of life data in cancer trials. Stat Med 17:781–796. doi:10.1002/(SICI)1097-0258(19980315/15)17:5/7<781::AID-SIM821>3.0.CO;2-O PubMedCrossRefGoogle Scholar
- 12.Galer BS, Jensen MP, Ma T, Davies PS, Rowbotham MC (2002) The lidocaine patch 5% effectively treats all neuropathic pain qualities: results of a randomized, double-blind, vehicle-controlled, 3-week efficacy study with use of the neuropathic pain scale. Clin J Pain 18:297–301. doi:10.1097/00002508-200209000-00004 PubMedCrossRefGoogle Scholar
- 14.Hurny C, Bernhard J, Coates A, Peterson HF, Castiglione-Gertsch M, Gelber RD, Rudenstam CM, Collins J, Lindtner J, Goldhirsch A, Senn HJ (1996) Responsiveness of a single-item indicator versus a multi-item scale: assessment of emotional well-being in an international adjuvant breast cancer trial. Med Care 34:234–248. doi:10.1097/00005650-199603000-00004 PubMedCrossRefGoogle Scholar
- 21.Loprinzi CL, Kugler JW, Sloan JA, Rooke TW, Quella SK, Novotny P, Mowat RB, Michalak JC, Stella PJ, Levitt R, Tschetter LK, Windschitl H (1999) Lack of effect of coumarin in women with lymphedema after treatment for breast cancer. N Engl J Med 340:346–350. doi:10.1056/NEJM199902043400503 PubMedCrossRefGoogle Scholar
- 25.Mandrekar JSD, Novotny PJ, Slaon JA (1999) A general Gibbs sampling algorithm for analyzing linear models using the SAS system. In: Proceedings of the SUGI, p 1644–1649Google Scholar
- 26.Mandrekar JSD, Novotny PJ, Slaon JA (1999) A general Gibbs sampling algorithm for analyzing linear models using the SAS system. SUGI Proc 24:1644–1649Google Scholar
- 31.Pergolizzi J, Boger RH, Budd K, Dahan A, Erdine S, Hans G, Kress HG, Langford R, Likar R, Raffa RB, Sacerdote P (2008) Opioids and the management of chronic severe pain in the elderly: consensus statement of an International Expert Panel with focus on the six clinically most often used World Health Organization step III opioids (buprenorphine, fentanyl, hydromorphone, methadone, morphine, oxycodone). Pain Pract 8:287–313. doi:10.1111/j.1533-2500.2008.00204.x PubMedCrossRefGoogle Scholar
- 35.Senn S (1993) Cross-over trials in clinical research. Wiley, New YorkGoogle Scholar
- 37.Sloan JANP, Lorinzi CL, Nair S (1997) Graphical and analytical tools for the analysis two-period crossover clinical trials. SUGI Proc 22:1312–1317Google Scholar
- 38.Sloan JA OFJ, Suman VJ, Sargeant DJ (1998) Incorporating quality of life measurement in oncology clinical trials. In: Proceedings of the American Statistical Association, p 281–287Google Scholar
- 40.Wiffen PJ, McQuay HJ, Edwards JE, Moore RA (2005) Gabapentin for acute and chronic pain. Cochrane Database Syst Rev CD005452Google Scholar
- 41.Wiffen PJ, McQuay HJ, Moore RA (2005) Carbamazepine for acute and chronic pain. Cochrane Database Syst Rev CD005451Google Scholar