|Year : 2022 | Volume
| Issue : 4 | Page : 185-191
Can the preemptive use of lornoxicam or paracetamol prevent pain after inguinal hernia repair? A randomized prospective double-blind placebo controlled trial
Alp Alptekin1, Zafer Ergul2, M Ercan Sonmez1, Celil Ugurlu2, Haluk Gumus1, Hakan Kulacoglu3
1 Department of Anaesthesia and Reanimation, Diskapi Yildirim Beyazit Teaching and Research Hospital, Ankara, Turkey
2 Department of Surgery, Diskapi Yildirim Beyazit Teaching and Research Hospital, Ankara, Turkey
3 Department of Surgery, Diskapi Yildirim Beyazit Teaching and Research Hospital, Ankara, Turkey; Ankara Hernia Center, Ankara, Turkey
|Date of Submission||26-Sep-2022|
|Date of Decision||06-Oct-2022|
|Date of Acceptance||17-Oct-2022|
|Date of Web Publication||24-Dec-2022|
Mesa Park Sitesi, Sogut Blok, No:28 Oran, Cankaya, Ankara
Source of Support: None, Conflict of Interest: None
INTRODUCTION: Nonsteroidal anti-inflammatory drugs have become a popular part of multimodal analgesic regimens particularly in ambulatory surgery. This study was designed to search the efficacy of preoperative administration of lornoxicam or paracetamol in patients who underwent open inguinal hernia repair. MATERIALS AND METHODS: American Society of Anesthesiologists Classification (ASA) I–III male patients with unilateral primary inguinal hernia scheduled for elective prosthetic repair under general anesthesia were randomly assigned to three groups. Group I patients were infused 100-ml normal saline 30 min before anesthesia (placebo), whereas Group II and Group III patients were given 8 mg lornoxicam or 1,000 mg paracetamol intravenously in 100-ml normal saline. Postoperative pain was treated with patient controlled intravenous morphine. Postoperative pain scores were evaluated with visual analog scale (VAS) in the recovery room and at 1st, 6th, 12th, and 24th hours postoperatively in all groups. Total amount of analgesics. Liker scale and SF-36 form was also used at 4th week follow-up in order assess quality of life. RESULTS: Totally 88 patients were completed the study (G1 = 28, G2 = 30, and G3 = 30). Preemptive use of both lornoxicam and paracetamol resulted in significantly lower recovery room VAS scores in comparison with placebo group (3.93, 3.73, and 5.25). Both lornoxicam and paracetamol groups (G2 and G3) displayed better results at 12th h than placebo group (P = 0.04). VAS scores at 24th hour were similar in three groups. Total morphine consumptions were also similar between the groups at all times. Total postoperative 1-week oral analgesic use was significantly less in G2 (lornoxicam), and G3 (paracetamol) in comparison with G1 (placebo). Quality of life indicators in Likert Scale and SF-36 form were also not different. CONCLUSION: Preemptive use of both lornoxicam and paracetamol may be effective in early postoperative pain control in patients undergo elective open inguinal hernia repair. However, there seems to be no difference between the efficacies of the two agents.
Keywords: Inguinal hernia, Lichtenstein, lornoxicam, paracetamol, preemptive analgesia
|How to cite this article:|
Alptekin A, Ergul Z, Sonmez M E, Ugurlu C, Gumus H, Kulacoglu H. Can the preemptive use of lornoxicam or paracetamol prevent pain after inguinal hernia repair? A randomized prospective double-blind placebo controlled trial. Int J Abdom Wall Hernia Surg 2022;5:185-91
|How to cite this URL:|
Alptekin A, Ergul Z, Sonmez M E, Ugurlu C, Gumus H, Kulacoglu H. Can the preemptive use of lornoxicam or paracetamol prevent pain after inguinal hernia repair? A randomized prospective double-blind placebo controlled trial. Int J Abdom Wall Hernia Surg [serial online] 2022 [cited 2023 Jan 28];5:185-91. Available from: http://www.herniasurgeryjournal.org/text.asp?2022/5/4/185/365094
| Introduction|| |
The major complaint of herniorrhaphy is postoperative pain which usually lasts for 24 h after operation. Postoperative pain causes distress that leads to prolonging recovery, and adversely affects patient’s outcome after surgery. It has been advocated that administration of analgesic drugs before the incision is made is more beneficial than their use after surgery. This concept is called preemptive analgesia. Kissin from Harvard Medical Scholl defined the preemptive analgesia as an antinociceptive treatment that prevents establishment of altered processing of afferent input, which amplifies postoperative pain. However, controversies about this modality have been continuing. Although there are some reports in favor of it, some studies have failed to show its efficacy.
Preemptive administration of nonsteroidal anti-inflammatory drugs (NSAIDs) proved to be effective in the management of early postoperative pain., In recent years acute postoperative pain has received increased attention by the development of new drugs for pain management. NSAIDs and paracetamol have become a popular part of multimodal analgesic regimens particularly in the ambulatory surgery. Both intravenously (i.v.) administered lornoxicam and paracetamol are safe and effective in postoperative pain management. Lornoxicam is used extensively for postoperative analgesia. Its ease of use and safety in the perioperative setting was demonstrated by several studies with no risk to patients. Lornoxicam containing regimens are as well tolerated as other analgesic regimens (over 4 days) in the treatment of postoperative pain. A recent clinical study compared lornoxicam and paracetamol for post-operative analgesia in patients undergoing elective laparotomy under general anesthesia, and found that the patients received preemptive lornoxicam required a significantly less amount of rescue analgesic postoperatively. However, there is a lack of data about the comparison of the effects of intravenous paracetamol and lornoxicam by means of randomized placebo controlled clinical studies on pain and quality of life following inguinal hernia surgery. This study was designed to search the efficacy of preoperative administration of lornoxicam or paracetamol in patients undergoing inguinal hernia repair.
| Materials and Methods|| |
This prospective double-blind, randomized, placebo-controlled trial was registered on www.clinicaltrials.gov (ID: NCT01069055). This study was approved by the Ethics Committee of Dikapi Yildirim Beyazit Teaching and Research Hospital. Written informed consents were obtained from all of the patients.
A prior small study with 5 patients for each group revealed effect size (f) 0.349, 80% power (1–β), and α error 0.05with software G. Power 3.0 indicated a total of 84 patients would be enough for the study.
Eligibility criteria and randomization
Eighty-eight American Society of Anesthesiologists Classification (ASA) I-III consecutive male patients with primary unilateral inguinal hernia scheduled for elective inguinal hernia repair under general anesthesia were included in the study. Patients with a history of chronic analgesics intake, gastrointestinal disorder, hypersensitivity to lornoxicam, paracetamol or any other NSAIDs, bleeding disorder, any systemic organ were not included to the study. Re-repairs for recurrent hernias were also excluded.
Primary outcome measure of the study was pain scores at 1st, 6th, 12th, and 24th postoperative hours. Secondary outcome measure was the evaluation of opioid consumption during first 24 postoperative hours, and oral analgesic consumption in the first week. Tertiary outcome measure was the assessment of the quality of life at 4th postoperative week.
The test drugs were prepared by a blind anesthetist according to a computer-generated random number schedule. Blinding was maintained throughout the treatment period and the master list was maintained with only the principal investigator (AA). The patients and the surgical team and anesthetist directly involved in the patient’s care were blinded to the study medication. A blind surgical resident carried out Likert questionnaire and short form 36 health survey (SF-36) at fourth postoperative week.
Group 1 (G1) patients were infused 100 mL normal saline i.v. as placebo, whereas the patients in Group 2 (G2) were given 8 mg lornoxicam i.v., the patients in Group 3 (G3) were given 1,000 mg paracetamol i.v. in 100 ml normal saline, 30 min before anesthesia. Patients were premedicated with midazolam 5 mg intramuscularly. The anesthetic protocol was standardized. Anesthesia was induced with propofol, 2.0–2.5 mg.kg-1 i.v., plus 0.5 µg.kg-1 fentanyl and followed by sevoflurane 2% with 60% nitrous oxide in oxygen. No additional fentanyl was applied. Sevoflurane concentration was adjusted to maintain ± 20% of baseline arterial blood pressure and/or heart rate. Neuromuscular block was provided by vecuronium 0.06 mg.kg-1 (reversed by neostigmine with atropine). Airway was controlled by a classical Laryngeal Mask Airway. Local infiltration or peripheral nerve block were not in our protocol at any time. Vital signs were recorded during the operation and then postoperatively for 24 h. Postoperative pain was treated with i.v. morphine. Patient-controlled analgesia (PCA) which was set as 1 mg bolus and 5 min lockout, 20 mg of hourly limit. Postoperative pain scores were assessed with a 100-mm visual analog scale (VAS) in the recovery room and at 1st, 6th, 12th, and 24th hours postoperatively in all groups. Total amount of analgesics and side effects were also recorded. The patients were discharged with the rescue medication Doladamon-P (15 mg codein and 300 mg paracetamol) and were instructed to maintain a log of the number of pills used postoperatively.
All operations were performed by experienced surgeons (HK and ZE) or by a senior resident (CU) under the same surgeons’ supervision. The surgical technique was Lichtenstein repair with standard polypropylene mesh sized 7 cm × 14 cm. Mesh was secured with 2-0 polydioxanone sutures. The aponeurosis of the external oblique muscle was closed with continuous 2-0 polyglactin suture. Then, superficial fascia was approached with separate 3-0 polyglactin sutures. The skin was closed continuously with 3-0 rapid polyglactin.
The patients were followed for a period of 4 weeks. They were seen in the clinic at first week for a routine postoperative follow-up and at fourth week afterwards. Likert Scale and SF-36 form were used for evaluation. Likert Scale were administered at first and fourth week to evaluate the pain response to normal daily activities (1––no difficulty, 2––a little difficulty, 3––some difficulty, 4––a lot of difficulty, 5––not able to do it, and 6––did not do for other reasons). Quality of life was measured with SF-36 form at fourth-week follow-up. Only five items of SF-36 form which reflect postoperative discomfort and pain were questioned.
Mann–Whitney U t test was used to compare the variables in three independent groups. Data were presented as mean values ± standard deviation. When standard deviation is very large the median values with minimums and maximums were given together. Median test was performed by using K independent samples.
SPSS for Windows, version 21 (IBM Corp, Armonk, New York) program was used for the study’s statistical analysis. The statistical significance limit was accepted as P < 0.05.
Means, standard deviation values, and medians were calculated. Differences between the study groups in baseline characteristics, and outcomes were assessed with t tests for normally distributed continuous variables and Wilcoxon–Mann–Whitney U tests for non-normal continuous variables. SPSS for Windows, version 21 (IBM Corp, Armonk, New York) program was used for the study’s statistical analysis. The statistical significance limit was accepted as P < 0.05.
| Results|| |
Totally 90 patient consecutive eligible patients were included, 30 patients in each group. Two patients dropped out in G1 since they did not return for first or fourth week postoperative follow-up. A total of 88 patients were evaluated. A flow diagram for trial participants was presented in [Figure 1]. The groups were comparable with respect to demographic characteristics, and surgery time [Table 1].
Preemptive use of both lornoxicam and paracetamol was resulted in lower recovery room VAS scores in comparison with placebo group although the difference did not reach well the level of significance (52.5 ± 11.8, 39.3 ± 16.7, and 37.3 ± 18.1; P = 0.06). Preemptive lornoxicam use displayed a better pain score than placebo and paracetamol groups at sixth hour, but the differences between the groups were not significant. G3 (paracetamol) showed the lowest VAS score at 12th our; both lornoxicam and paracetamol groups (G2 and G3) displayed better results at 12th h than placebo group (P = 0.04). VAS scores of all groups were similar at 24th h [Table 2]. Total morphine consumptions were similar between the groups at all times [Table 3]. Total postoperative 1-week oral Doladamon-P use was less in lornoxicam and paracetamol groups in comparison with placebo group (P = 0.05).
The Likert scale scores of G2 and G3 were lower than that of G1 at first week, and the difference were close to the level of significance (P = 0.07). The scores of the groups at fourth week were similar. Likert scores displayed obvious decreases in all groups between first and fourth weeks [Table 4]. Also, there were no differences between three groups regarding quality of life in SF-36 survey at fourth week. Five items of SF-36 form (Q1, Q3, Q4, Q7, and Q8) displayed similar scores for all groups [Table 5].
|Table 5: Mean scores for five pain related items of SF-36 form at fourth week|
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| Discussion|| |
Poor pain control after surgery causes pathophysiological status and may lead to chronic pain. Several studies have demonstrated that postoperative pain is still a problem for patients after inguinal hernia repair. The incidence of moderate to severe pain may reach 30% in patients who undergo ambulatory surgery. NSAIDs are useful alternative agents and often administered as part of a multimodal analgesic regimen for both treating and preventing pain after ambulatory surgery. This group of analgesics is proven to reduce the postoperative pain after inguinal hernia surgery in comparative studies., Paracetamol has also been found effective in control of postoperative pain. Its preemptive use is more effective than placebo in inguinal hernia surgery in children. Preemptive use of paracetamol has also been evaluated in dental surgery. Kano et al. reported that patient in preemptive administration group needed significantly lower rescue analgesic consumption and longer duration of analgesia in comparison with the patients who received the drug after surgery. Nevertheless, VAS scores of the groups at 1st, 2nd, 3rd, 4th, 5th, and 15th hours after surgery were similar. Patel et al. compared the efficacies of peroral and intravenous paracetamol use as preemptive agent in laparoscopic inguinal hernia repair, and found not differences.
Lornoxicam (chlortenoxicam), a new NSAID of the oxicam class with analgesic, anti-inflammatory and antipyretic properties, is available in oral and parenteral formulations. Hall et al. investigated the effect of single dose oral lornoxicam in acute postoperative pain. Authors assessed three comparative studies with 628 participants treated with various doses (2–32 mg) of lornoxicam. This Cochrane Database Systematic Review concluded that oral lornoxicam is effective at treating moderate to severe acute postoperative pain in comparison with placebo and other active therapies, based on limited data. Lornoxicam can be used peroral, i.v., intramuscularly, and also by local infiltration.,, Ismail et al. compared i.v. route and locally applied lornoxicam in tonsillectomy patients. Their data showed that preoperative lornoxicam administration resulted in a significant reduction in pain scores postoperatively in the infiltration and i.v. groups with no significant difference between them. Eren et al. compared the efficacy of intraarticular application of lornoxicam, bupivacaine and placebo on postoperative pain after arthroscopic knee surgery. Their conclusion is intraarticular lornoxicam provided better pain control than bupivacaine and saline. Mentes and Bagci compared the analgesic effects of lornoxicam and tramadol during 24 h in 160 consecutive patients after elective unilateral inguinal hernia repair in a double blind, randomized study. They reported that lornoxicam 16 mg and 1 mg/kg tramadol every 6 h up to 24 h postoperatively gave same analgesia. Preemptive use of lornoxicam was also investigated in a prospective randomized study by Karaman et al. Intravenous injection of 8 mg lornoxicam significantly reduced postoperative pain in comparison with placebo in patients who underwent major abdominal surgery. However, mean VAS score for preemptive lornoxicam use was significantly lower only at postoperative second hour comparing its postoperative use.
Comparison of paracetamol and lornoxicam regarding postoperative pain has been studied in different surgical areas. Arslan et al. reported that both lornoxicam and paracetamol were effective at the control of postoperative pain and reduction of opioid consumption after thyroidectomy when they were administrated at the end of surgery. Howafi et al. also compared two drugs in patients underwent lower abdominal surgery. Their patients were given the drugs during skin closure and postoperatively, and found that lornoxicam is superior to paracetamol for postoperative analgesia. Hein et al. also compared the preemptive effects of these two agents in female patients scheduled for elective termination of pregnancy. The patients in two groups were given either 1 g paracetamol or 8 mg lornoxicam orally 60 min before the procedure. They found that preemptive paracetamol was not effective, whereas preoperative administration of lornoxicam seemed to have a significant effect in postoperative pain control. Bilir et al. carried out a similar study for lumbar disc surgery and reported that preemptive use of lornoxicam is significantly better in postoperative pain control and reduction in opioid use. However not all studies to date revealed the superiority of lornoxicam over paracetamol. Another study in patients underwent lumbar disc surgery was reported by Korkmaz et al. They compare the efficacies of intravenous lornoxicam, paracetamol, and metamizole which were given at the end of the surgery. Metamizol and paracetamol reduced the postoperative pain, whereas as lornoxicam was not found to be effective.
In the present study, we used two different analgesic agents by the intention of preemptive analgesia like some of the previous studies. Although our findings presented better results with preemptive analgesia either with lornoxicam or paracetamol, there was no differences between these two agents. Both agents provided low VAS scores after inguinal hernia repair in comparison with placebo groups, but opioid need in the first 24 h did not decrease. Nevertheless, preemptive analgesia lowered the oral analgesic consumption throughout the first week. Apart from VAS score evaluation a measurement of quality of life was also included in the present study. Patients received preemptive analgesia presented slightly better scores in Likert Scale at 1st postoperative week, but the differences were significant. All groups showed similar values at 4th week. Neither drug was found to be superior to each other. Also, similar results were obtained by SF-36 Form questionnaire at fourth week. Lornoxicam and paracetamol provided no benefit over placebo regarding quality of life 4 weeks after surgery. Another study which evaluated the quality of life after Lichtenstein repair was carried out Turaga et al. by using rofecoxib, which is a COX-2 inhibitor. One test group received rofecoxib only in the postoperative period, and other group both in the pre- and postoperative period. The authors stated that there were no differences in SF-36 health survey between two test groups and the control group, although the postoperative use of rofecoxib provided lower amount of pain and decreased need for narcotics.
The main limitation of the present study is the lack of preoperative pain measurements. Recent studies have shown that preoperative pain levels of inguinal hernia patients may be related to the postoperative pain complaints., Therefore, it would be valuable to see a similarity for preoperative pain levels as homogeneities of the groups were displayed regarding age, ASA score and body weight.
| Conclusion|| |
Preemptive use of both lornoxicam and paracetamol may be effective in early postoperative comfort in patients undergo elective open inguinal hernia repair. There seem to be no significant differences between the efficacies of the two agents. However, these positive effects of two agents were not valid for quality of life indicators after 4 weeks.
Financial support and sponsorship
Conflicts of interest
Dr. Hakan Kulacoglu is an Editorial Board member of International Journal of Abdominal Wall and Hernia Surgery. The article was subject to the journal’s standard procedures, with peer review handled independently of this Editorial Board member and their research groups.
Human and animal rights statement
This study including human participants has been performed in accordance with the ethical standards of the Declaration of Helsinki and its later amendments.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]