Efficacy of preprocedural diclofenac in men undergoing double J stent removal under local anesthesia: A double-blind, randomized control trial

Vilvapathy Senguttuvan Karthikeyan, Ramaiah Keshavamurthy, Ashwin Mallya, Manohar Chikka Moga Siddaiah, Sumit Kumar, Chulai Rajabahadhur Chandrashekar, Vilvapathy Senguttuvan Karthikeyan, Ramaiah Keshavamurthy, Ashwin Mallya, Manohar Chikka Moga Siddaiah, Sumit Kumar, Chulai Rajabahadhur Chandrashekar

Abstract

Introduction: Double J (DJ) stents are often removed under local anesthesia using a rigid cystoscope. Patients experience significant pain during this procedure and also continue to have discomfort during voiding for a few days. We assessed the efficacy and safety of preemptive oral diclofenac in pain relief in patients undergoing DJ stent removal (DJSR) by rigid cystoscopy compared to placebo.

Methods: Consecutive consenting male patients undergoing DJSR under local anesthesia between March 2014 and July 2015 were enrolled. Patients were randomized to receive 75 mg oral diclofenac (Group A) or placebo (Group B) 1 h before procedure by double-blind randomization. Intraurethral 2% lignocaine gel (25 ml) was used in both groups. Pain during rigid cystoscopy, pain at the first void, and at 24 h after cystoscopy was assessed using visual analog scale (VAS) (0-100). Adverse reactions to diclofenac and episodes of acute urinary retention, if any, were assessed (Trial registered at clinicaltrials.gov: NCT02598102).

Results: A total of 121 males (Group A [n = 62]; Group B [n = 59]) underwent stent removal. The median (Interquartile range) VAS during the procedure in Group A was 30 (30) and Group B was 60 (30) (P < 0.001), at first void was 30 (30) and 70 (30) (P < 0.001) and at 24 h postoperatively was 20 (20) and 40 (20) (P < 0.001). The incidence of epigastric pain, nausea, vomiting, and acute urinary retention was comparable in the two groups (P > 0.05).

Conclusions: A single oral dose of diclofenac administered 1 h before DJSR using rigid cystoscope under intraurethral lignocaine anesthesia decreases pain significantly during and up to 24 h postprocedure with minimal side effects.

Conflict of interest statement

There are no conflicts of interest.

Figures

Figure 1
Figure 1
CONSORT diagram for the trial. VAS = Visual analog scale, A = Patients receiving diclofenac, B = Patients receiving placebo

References

    1. Kobayashi T, Nishizawa K, Mitsumori K, Ogura K. Instillation of anesthetic gel is no longer necessary in the era of flexible cystoscopy: A crossover study. J Endourol. 2004;18:483–6.
    1. Chen YT, Hsiao PJ, Wong WY, Wang CC, Yang SS, Hsieh CH. Randomized double-blind comparison of lidocaine gel and plain lubricating gel in relieving pain during flexible cystoscopy. J Endourol. 2005;19:163–6.
    1. McFarlane N, Denstedt J, Ganapathy S, Razvi H. Randomized trial of 10 mL and 20 mL of 2% intraurethral lidocaine gel and placebo in men undergoing flexible cystoscopy. J Endourol. 2001;15:541–4.
    1. Herr HW, Schneider M. Outpatient flexible cystoscopy in men: A randomized study of patient tolerance. J Urol. 2001;165(6 Pt 1):1971–2.
    1. Komiya A, Endo T, Kobayashi M, Kim W, Araki K, Naya Y, et al. Oral analgesia by non-steroidal anti-inflammatory drug zaltoprofen to manage cystoscopy-related pain: A prospective study. Int J Urol. 2009;16:874–80.
    1. Aubrun F, Langeron O, Quesnel C, Coriat P, Riou B. Relationships between measurement of pain using visual analog score and morphine requirements during postoperative intravenous morphine titration. Anesthesiology. 2003;98:1415–21.
    1. Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: A reanalysis of two clinical trials of postoperative pain. J Pain. 2003;4:407–14.
    1. Calleary JG, Masood J, Van-Mallaerts R, Barua JM. Nitrous oxide inhalation to improve patient acceptance and reduce procedure related pain of flexible cystoscopy for men younger than 55 years. J Urol. 2007;178:184–8.
    1. Young A, Ismail M, Papatsoris AG, Barua JM, Calleary JG, Masood J. Entonox ® inhalation to reduce pain in common diagnostic and therapeutic outpatient urological procedures: A review of the evidence. Ann R Coll Surg Engl. 2012;94:8–11.
    1. Khan MA, Beyzade B, Tau W, Virdi JS, Potluri BS. Effect of the rate of delivery of lignocaine gel on patient discomfort perception prior to performing flexible cystoscopy. Urol Int. 2002;68:164–7.
    1. Goldfischer ER, Cromie WJ, Karrison TG, Naszkiewicz L, Gerber GS. Randomized, prospective, double-blind study of the effects on pain perception of lidocaine jelly versus plain lubricant during outpatient rigid cystoscopy. J Urol. 1997;157:90–4.
    1. Livadas KE, Varkarakis IM, Skolarikos A, Karagiotis E, Alivizatos G, Sofras F, et al. Ureteroscopic removal of mildly migrated stents using local anesthesia only. J Urol. 2007;178:1998–2001.
    1. Arpaci AH, Bozkırlı F. Comparison of sedation effectiveness of remifentanil-dexmedetomidine and remifentanil-midazolam combinations and their effects on postoperative cognitive functions in cystoscopies: A randomized clinical trial. J Res Med Sci. 2013;18:107–14.
    1. Metz P, Halveg JO. Pethidine-diazepam analgesia for cystoscopy. Anaesthesia. 1974;29:92–5.
    1. Collin RI, Drummond GB, Spence AA. Alfentanil supplemented anaesthesia for short procedures. A double-blind study of alfentanil used with etomidate and enflurane for day cases. Anaesthesia. 1986;41:477–81.
    1. Wall PD. The prevention of postoperative pain. Pain. 1988;33:289–90.
    1. Bond MR, Charlton JE, Woolf CJ, editors. Proc 6 th World Congress on Pain. Amsterdam: Elsevier. 1991:25–34.
    1. Ong CK, Lirk P, Seymour RA, Jenkins BJ. The efficacy of preemptive analgesia for acute postoperative pain management: A meta-analysis. Anesth Analg. 2005;100:757–73.
    1. Aida S, Baba H, Yamakura T, Taga K, Fukuda S, Shimoji K. The effectiveness of preemptive analgesia varies according to the type of surgery: A randomized, double-blind study. Anesth Analg. 1999;89:711–6.
    1. Reuben SS, Bhopatkar S, Maciolek H, Joshi W, Sklar J. The preemptive analgesic effect of rofecoxib after ambulatory arthroscopic knee surgery. Anesth Analg. 2002;94:55–9.
    1. Davies NM, Anderson KE. Clinical pharmacokinetics of diclofenac. Therapeutic insights and pitfalls. Clin Pharmacokinet. 1997;33:184–213.
    1. Furuta S, Akagawa N, Kamada E, Hiyama A, Kawabata Y, Kowata N, et al. Involvement of CYP2C9 and UGT2B7 in the metabolism of zaltoprofen, a nonsteroidal anti-inflammatory drug, and its lack of clinically significant CYP inhibition potential. Br J Clin Pharmacol. 2002;54:295–303.

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