Introduction: Adequate pain control is essential in immediate postoperativeperiod. Different methods are being used to provide pain management but none of these is completely effective. Regional blocks are becoming more popular then systemic opioids in all age groups due to efficacy and safety of agents used. The objective of this study was to establish the effectiveness of tramadol and bupivacaine for pain control after inguinal herniotomy in children.Materials and Methods: This randomized controlled trial was conducted at pediatric surgery department, services hospital Lahore over 2 years. Two hundred and eighty four cases randomly divided into two groups B (Bupivacaine) &amp; T (Tramadol). Bupivacaine (dose of 2 mg/kg) in group B or Tramadol (2mg/kg) in group T was infiltrated in the wound. Postoperatively pain score was measured using Wong-Baker Faces pain scale (WBFPS) at 0,1,2,4 and 8 hours. Both groups experienced side effects.Results: Age and gender distribution in both groups were comparable. Pain score in both Groups was equal at 0- hours. However at 1-hour, 2-hour and 4-hour, pain score was slightly more in Group-B, But at 8-hours mean pain score was markedly raised in Group-B as compared to Group-T (3.32 ± 1.42 vs 2.45 ± 1.35). Only complication noted in patients was vomiting which was higher in Group T.Conclusion: Locally infiltrated Tramadol is a better choice than bupivacaine as a local anesthetic for pain management in children after inguinal herniotomy. Further research is needed to elucidate any benefits it may have in other surgeries

Dar, Sajid Hameed

Iqbal, Asif

Liaqat, Naeem

English

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54OrginalComparison of Local Infiltration of Bupivacaine and Tramadol in Post-Operative Pain Management in Children after Inguinal HerniotomyAsif Iqbal1*                                           Naeem Liaqat2                                              Sajid Hameed Dar31Institute of Child Health / Children Hospital, Lahore (ICH/CH)2Rawalpindi Medical University (RMU), Pakistan3Services Hospital, Lahore, Pakistan*Address for Corresponder: Dr. Asif Iqbal,Institute of Child Health / Children Hospital, Lahore (ICH/CH) (e- mail: asiffsandhu@yahoo.com)How to cite this article: Iqbal A, Liaqat N, Dar SH. Comparison of local infiltration of bupivacaine and tramadol in post-operative pain management in children after inguinal herniotomy. Iranian Journal of Pediatric Surgery 2018; 4 (2):54 -60 .DOI: https://doi.org/10.22037/irjps.v4i2.21641Introduction: Adequate pain control is essential in immediate post-operative period. Different methods are being used to provide pain management but none of these is completely effective. Regional blocks are becoming more popular then systemic opioids in all age groups due to efficacy and safety of agents used.  The objective of this study was to establish the effectiveness of tramadol and bupivacaine for pain control after inguinal herniotomy in children.Materials and Methods: This randomized controlled trial was conducted at pediatric surgery department, services hospital Lahore over 2 years. Two hundred and eighty four cases randomly divided into two groups B (Bupivacaine) & T (Tramadol). Bupivacaine (dose of 2 mg/kg) in group B or Tramadol (2mg/kg) in group T was infiltrated in the wound. Postoperatively pain score was measured using Wong-Baker Faces pain scale (WBFPS) at 0,1,2,4 and 8 hours. Both groups experienced side effects.Results: Age and gender distribution in both groups were comparable. Pain score in both Groups was equal at 0- hours. However at 1-hour, 2-hour and 4-hour, pain score was slightly more in Group-B, But at 8-hours mean pain score was markedly raised in Group-B as compared to Group-T (3.32 ± 1.42 vs 2.45 ± 1.35). Only complication noted in patients was vomiting which was higher in Group T.Conclusion: Locally infiltrated Tramadol is a better choice than bupivacaine as a local anesthetic for pain management in children after inguinal herniotomy. Further research is needed to elucidate any benefits it may have in other surgeries.AbstractKeywords•  Inguinal herniotomy•  Children•  Postoperative pain•  Bupivacaine•  Tramadol•  efficacy  received: 29 September 2018accepted: 18 October 2018           ISSN 2423-5067Iranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201855   Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy                                  Liaqat et al.Introduction According to International Association for the Study of Pain, “Pain is an unpleasant sensory and emotional experience associated with actual or potential tissue damage”.1 Recent clinical studies have demonstrated that almost 40% of hospitalized children experience moderate to severe pain during their hospital stay2. Effective post operative analgesia may be attained by various techniques. These methods include; systemic use of opioids, non steroidal anti-inflammatory drugs and local anesthetic infiltration.3 Each of these techniques has its own advantages and disadvantages. Bupivacaine is a local anesthetic drug, with a long duration of action. It belongs to the amide group of local anesthetics and is a commonly used anesthetic agent for epidural, spinal, nerve block or infiltration anesthesia.4 It is safe when administered correctly. Side effects from systemic absorption of toxic quantities of bupivacaine may result primarily in the central nervous (CNS) and cardiovascular (CVS) symptoms. CNS effects include tinnitus, tremor, circumoral paresthesia, nervousness, anxiety, vertigo, blurring of vision, seizures, unconsciousness and depression of respiration leading to apnea. Effects on the CVS range from bradycardia, hypotension and arrhythmias to irreversible cardiac arrest.5Tramadol is a centrally acting synthetic opioid drug, after systemic administration it acts at supra-spinal as well as spinal sites. There are several references in available literature about its additional local anesthetic properties. So it can be used for local infiltration as well as for systemic administration. Tramadol has no clinically relevant depressant effects on respiration. 6, 7The objective of the study was to compare mean pain score after local infiltration of Bupivacaine with Tramadol in pain control after inguinal herniotomy in children.Materials and MethodsThis Randomized controlled trial was carried out at the Department of Pediatric Surgery, Services Institute of Medical Sciences/Services Hospital, Lahore. It was conducted over a period of two years from January 2014 to December 2016 after the approval of synopsis from ethical review board. The sample was calculated to be 284 patients taking mean pain in tramadol group as 1.44 ±0.58 and in the bupivacaine group 1.72±0.61, 95% confidence level (5% alpha level) and 80% power of study. Children aged 4 to 12 years planned to have elective inguinal herniotomies were included. Patients with obstructed inguinal hernia, bilateral inguinal hernia, receiving additional caudal block & having other co-morbid conditions i.e respiratory, cardiovascular and neurological disorders were excluded from the study. They were randomly divided by computer generated numbers into two equal groups: group B and group T. A written consent was taken from the parents for including their child’s data in this study. General anesthesia (GA) was induced in a standard way, inhalation agents were used for induction and air way was secured along with standard monitoring. Inguinal herniotomy was done, in a standard manner in both groups. After herniotomy and before closure of skin, Bupivacaine (2mg/kg) in group B patients and Tramandol (2mg/kg) in group T patients were infiltrated at wound site. For Post-operative pain assessment we used Iranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201856Wong baker faces pain scale (WBFPS). Consent for using WBFPS was obtained from publishers. Postoperatively patients were assessed for pain using Wong Bakers Faces pain scale at 0, 1, 2, 4, 6 and 8 hours after surgery. Monitoring was started once patient were taken to the recovery room which was considered as zero hour. If the patient developed pain score ≥4, Nalbuphine 0.2 mg/kg was administered intravenously as rescue analgesia and it was recorded. The collected data was entered and analyzed using SPSS (Statistical Package for the Social Sciences) version 21. Frequencies and percentages were calculated for qualitative variables quantitative data were presented in form of mean ± S.D. Independent sample T test was used to compare mean pain level (at 0, 1, 2, 4, 8 hours) and time to require analgesia in both study groups. Chi-square test applied for comparison, rescue analgesia given, vomiting, pruiritis, respiratory depression and efficacy in both groups. P-value ≤ 0.05 was considered significant.Results A total of 284 cases (142 in each group) were enrolled in this study. Mean age was calculated as 7.1056 ± SD years in Group-B and 7.5423 ± SD years in Group-T. In group B 85.2% patients were male and 14.8% were female while in group T Male and female were 81.7 and 18.6 respectively. In group B 99 patients had right sided and 43 had left sided inguinal hernia. In group T 91 had right sided and 51 patients had left sided inguinal hernia Table1.   Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy                                    Liaqat et al.Table 1: Descriptive Statistics for Patient’s Age, Gender and Side Hernia Group B Group TAge 7.10 7.54 Gender MaleFemalen=14285.2%14.8%n=14281.7%18.3% Side of hernia Right Leftn= 14269.7%30.3%n= 14264.1%35.9%Mean pain score in both groups was almost equal at hour 0 and 1. However at hour 2, 4 and 8, pain score was significantly less in Group-T than Group-B. All the data is summarized in Table 2.Iranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201857Table 2: Comparison of Pain Score in Both Groups Grou p B)Mean ± SD(Group T               P value)Mean ± SD(hour 0 0.49 ± 0.45 083.                0.5 ± 0.47hour 1 0.67 ± 1.66 012.              0.65 ± 1.59hour 2 0.77 ± 2.10 004.              0.79 ± 2.00hour 4 ±1.27 2.95 000.              1.29 ± 2.65hour 8 1.42 ± 3.32 000.              1.35 ± 2.45  Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy                                Liaqat et al.Number of patients receiving rescue analgesia in group B was 53(37%) while in group T it was 20 (14.08%). Side effects were noted in both groups. Vomiting occurred in 4 patients (2.8%) in group T while only one patient (0.7%) in group B experienced vomiting. Other side effects including pruritus and respiratory depression did not occurre in any of our patients. The mean time at which rescue analgesia was used for the first time post-operatively was 5.14± 1.95 hours in group B, while in group T it was 7.37± 1.05 hours.Discussion Current options for post-operative pain control in pediatric age group are NSAIDs, opioids and paracetamol. NSAIDs are limited by their adverse effects which include bleeding tendency, renal impairment, and aggravation of asthma. 8  Opioids are considered as the drug of choice for managing postoperative pain in adults; however, their use in paediatric patients is limited due to their adverse effects. 9 A drug with lesser side effects & effective in moderate to severe pain is the need of the hour. As yet not a single drug or technique for post-operative analgesia has proven to be decidedly superior to the rest. 10 Many studies have shown that wound infiltration with local anesthetics is effective during the post operative period. Garimella V et al also reported that intraoperative bupivacaine wound infiltration is associated with a decreased need for postoperative parenteral narcotics. 11 It is an established fact that tramadol can produce local anesthetic effect; the mechanism of which is poorly understood. It is also notable for absence of any clinically significant effect on respiration or cardiovascular system 12 A study conducted by Buccellati et al in 2000 reported that it has anti-inflammatory properties along with anesthetic effects 13 Sousa AM et al believed that the sensory blocking action of tramadol is due to blocking the voltage-depended Na channel similar to that of local anaesthetics. 14 In our study, when tramadol was compared with bupivacaine after local infiltration in the herniotomy wound, it provided better analgesia during the postoperative period (7.14 ± 1.05 hours for tramadol compared with 5.37 ± 1.95 hours for bupivacaine). In a study by Kaki et al. Iranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201858  Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy Liaqat et al.bupivacaine 0.25% and tramadol were compared for the treatment of pain following adult inguinal hernia repair 15 and it was shown that tramadol provided better analgesia compared to bupivacaine and for a longer duration.  Altunkaya et al & S Buhari et al reported similar local anesthetic effect of subcutaneous infiltration of 2 mg/kg tramadol and 1 mg/kg lidocaine 16, 17 Similar findings were noted by Afaq et al in a study conducted in adults comparing postoperative pain after inguinal hernia repair. They had found mean postoperative pain relief time to be 8.2 hours after Bupivacaine and 11.6 hours after Tramadol infiltration. 18In our study vomiting as a side effect was noted in only one patient in the Bupivacaine group while it occurred in 4 patients in the tramadol group which were comparable to the previous studies. Demiraran et al conducted a study and found no adverse reactions in either group. 19 Bahanur Cekıc also found that postoperative complications including itching nausea and vomiting occurred after tramadol as well as bupivacaine use. However there was no difference in the rate of adverse reactions in both groups. 20 Altunkaya et al. only found nausea as an adverse reaction16 In another study, Ozcengiz et al. found that frequency of nausea and vomiting after use of tramadol was similar to that seen after use of caudal morphine in children undergoing inguinal hernia repair. He also noted other post-operative complications during his study including delay in the first post operative micturition (206.75 ± 17.81 min versus 203.28 ± 16.93 min), pruritus (three patients in each groups) and nausea (two patients in each group). 21 ConclusionAfter wound infiltration with tramadol, the duration of post-operative analgesia significantly increased. Tramadol is an acceptable and suitable alternative to bupivacaine for pain control after inguinal hernia surgery in children because it has sustained effects over a longer period of time and reduces post-operative analgesia requirement. However, its benefit in other procedures remains to be proven, and further research is needed in this area.Ethics ApprovalThis study was approved by the services institute of Medical Sciences/Services Hospital Lahore Ethical Committee on 29.07.2013.Conflict of InterestThere is no conflict of interest.ORCID ID: Asif Iqbal  https://orcid.org/0000-0002-6318-368XReferences1. Main C, Watson P: Psychological aspects of pain. Manual therapy 1999;4(4):203-15.2. Walker SM: Pain after surgery in children: clinical recommendations. Current opinion in anaesthesiology 2015;28(5):570.3. Liaqat N, Dar SH: Comparison of single-dose nalbuphine versus tramadol for postoperative painIranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201859management in children: a randomized, controlled trial. Korean J Anesthesiol 2017;70(2):184-7.4.  Balakrishnan K, Ebenezer V, Dakir A, et al: Bupivacaine versus lignocaine as the choice of locall anesthetic agent for impacted third molar surgery a review. Journal of pharmacy & bioallied sciences 2015;7(Suppl 1):S230.5.  Stewart J, Kellett N, Castro D: The central nervous system and cardiovascular effects of levobupivacaine and ropivacaine in healthy volunteers. Anesth Analg 2003;97(2):412-6, table of contents.6.  Sahmeddini MA, Azemati S, Motlagh EM: Local Infiltration of Tramadol versus Bupivacaine for Post Cesarean Section Pain Control: A Double-Blind Randomized Study. Iranian journal of medical sciences 2017;42(3):235.7.  Desai SN, Badiger SV, Tokur SB, et al: Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study. Indian journal of anaesthesia 2017;61(3):225.8.  Neagu S, Tudor C, Dincă V, et al: Postoperative pain management in elderly patient. Rev Med Chir Soc Med Nat Iasi 2007;111(1):135-43.9.  Ahmadi A, Bazargan-Hejazi S, Zadie ZH, et al: Pain management in trauma: A review study. Journal of Injury and Violence Research 2016;8(2):89.10.  de Almeida MCSe, de Figueiredo Locks G, et al: Postoperative analgesia: comparing continuous epidural catheter infusion of local anesthetic and opioid and continuous wound catheter infusion of local anesthetic. Brazilian Journal of Anesthesiology 2011;61(3):293-303.11.  Garimella V, Cellini C: Postoperative pain control. Clin Colon Rectal Surg 2013;26(3):191-6.12.  Nasr YM, Waly SH: Lidocaine-tramadol versus lidocaine-dexmedetomidine for intravenous regional anesthesia. Egyptian Journal of Anaesthesia 2012;28(1):37-42.13.  Buccellati C, Sala A, Ballerio R, et al: Tramadol anti-inflammatory activity is not related to a direct inhibitory action on prostaglandin endoperoxide synthases. European Journal of Pain 2000;4(4):413-5.14.  Sousa A, Ashmawi HA, Costa LS, et al: Percutaneous sciatic nerve block with tramadol induces analgesia and motor blockade in two animal pain models. Brazilian Journal of Medical and Biological Research 2012;45(2):147-52.15.  Al AMKW: Post-herniorrhaphy infiltration of tramadol versus bupivacaine for postoperative pain relief: a randomized study. Annals of Saudi medicine 2008;28(3):165.16.  Altunkaya H, Ozer Y, Kargi E, et al: The postoperative analgesic effect of tramadol when used as subcutaneous local anesthetic. Anesthesia & Analgesia 2004;99(5):1461-4.17.  Buhari S, Hashim K, Yong Meng G, et al: Subcutaneous administration of tramadol after elective   Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy                                 Liaqat et al.Iranian Journal of Pediatric Surgery   Vol. 4     No. 2/ 201860  Local Infiltration of Bupivacaine and Tramadol in Inguinal Herniotomy                                  Liaqat et al.surgery is as effective as intravenous administration in relieving acute pain and inflammation in dogs. The Scientific World Journal 2012;2012.18.  Malik AI, Sheikh IA, Shahzad Ahmed Qasmi AA: Comparison of tramadol with bupivacaine as local anaesthetic in postoperative pain control. Journal of Surgery Pakistan (International) 2011;16(1):10-3.19.  Demiraran Y, Ilce Z, Kocaman B, et al: Does tramadol wound infiltration offer an advantage over bupivacaine for postoperative analgesia in children following herniotomy? Pediatric Anesthesia 2006;16(10):1047-50.20.  Cekic B, Geze S, Erturk E, et al: A comparison of levobupivacaine and levobupivacaine-tramadol combination in bilateral infraorbital nerve block for postoperative analgesia after nasal surgery. Annals of plastic surgery 2013;70(2):131-4.21.  Ozcengiz D, Gunduz M, Ozbek H: Comparison of caudal morphine and tramadol for postoperative pain control in children undergoing inguinal herniorrhaphy. Pediatric Anesthesia 2001;11(4):459-64.

Comparison of Local Infiltration of Bupivacaine and Tramadol in Post- Operative Pain Management in Children after Inguinal Herniotomy

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Comparison of Local Infiltration of Bupivacaine and Tramadol in Post- Operative Pain Management in Children after Inguinal Herniotomy

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