Journal of Pediatric Urology (2015) 11, 124.e1e124.e5

Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study a

Department of Urology, Dıs‚kapı Yıldırım Beyazıt Training and Research Hospital, _Irfan Bas‚tu g Cad. Dıs‚kapı, Ankara 06110, Turkey

b Department of Anaesthesiology, Dıs‚kapı Yıldırım Beyazıt Training and Research Hospital, _Irfan Bas‚tug Cad. Dıs‚kapı, Ankara 06110, Turkey

Correspondence to: N. Karakoyunlu, Eryaman Mahallesi 2, Cadde 15/20 Etimesgut, Ankara, Turkey, Tel.: þ90 5324747134; fax: þ90 3123186690 [email protected] (N. Karakoyunlu) Keywords Circumcision; Dorsal Slit; Sleeve; Pain Received 17 September 2014 Accepted 8 January 2015 Available online 3 March 2015

N. Karakoyunlu a, R. Polat b, G.B. Aydin b, J. Ergil b, T. Akkaya b, H. Ersoy a Summary Background Male circumcision (MC) is one of the most commonly used surgical procedures worldwide for medical and traditional reasons. No studies have compared the postoperative pain advantages of conventional techniques (i.e., sleeve and dorsal slit). Objective In this prospective randomized double-blind study, we investigated the effect of two surgical techniques (i.e., sleeve and dorsal slit) on postoperative pain and emergence agitation. Study design This prospective study was conducted between January and July 2013. Approval was obtained from the local Ethical Committee on 17 December 2012, 06/23 (Clinical trials identifier: NCT 01909765). We compared two surgical techniques (i.e., the dorsal slit incision technique (Group A) and the double incision (i.e., sleeve) technique (Group B) in 60 children who were subjected to MC surgery under general anesthesia. All children received dorsal nerve blocks with bupivacaine. The modified objective pain scale (MOPS) was used for pain assessment, and the Ramsey Sedation Scale was used for the assessment of agitation during anesthesia emergence. Results The MOPS scores were lower in Group B than in Group A in the post-anesthesia care unit and during the 4th hour post-surgery (p Z 0.01 and p Z 0.037,

respectively). Twelve children (40%) in Group A and 23 children (76.6%) in Group B required no additional analgesia on postoperative day one (p Z 0.004). The Ramsey sedation scores were lower in Group A (p Z 0.018). Discussion Dorsal slit is often the primary method in cases with paraphimosis; during this procedure, the frenulum frequently cannot be preserved at the 6-o’clock position of the mucosa, because of traction applied to skin and mucosa. As a result, the frenular artery is injured. In contrast, the sleeve technique protects the frenulum and the anatomic structures of the glans. In the sleeve technique, providing hemostasis and preventing partial ischemia by protecting the frenular artery reduces postoperative pain and complications. This present study demonstrated that the sleeve technique, which preserved the frenular artery, caused less bleeding, reduced electrocautery use and less ischemia than the dorsal slit technique. The sleeve technique effectively reduces early postoperative pain and agitation after circumcision, provided that adequate postoperative analgesia has been achieved. While all variables except the employed surgical techniques were similar, Group B had advantages with respect to analgesic requirement and pain control during the first 8 h after the operation. Conclusion The sleeve technique provides lower pain scores and a reduced incidence of agitation after elective MC.

http://dx.doi.org/10.1016/j.jpurol.2015.01.002 1477-5131/ª 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Surgical circumcision procedures on postoperative pain

Introduction Male circumcision (MC) is one of the most commonly performed surgical procedures and has both medical and traditional indications [1]. Postoperative pain control has attracted considerable attention in relation to MC. A number of analgesic and anesthesia methods have been used, and the efficiency and reliability of these methods have been compared in combination with the use of ancillary equipment, such as Plasti Bell, Mogen, and Gomco clamps; however, no studies that compare the effectiveness of conventional surgical techniques are available. Sleeve (i.e. double incision) and dorsal slit are widely used MC techniques. In the dorsal slit technique, the prepuce is incised together with the skin and mucosa. In the sleeve technique, the skin and mucosa are incised separately; during this incision, the frenular artery is spared by an incision approximately 0.5 cm away from the frenulum, which reduces ischemic pain [2]. The aim of the present study was to compare the effect of two elective circumcision surgical techniques on postoperative pain and emergence agitation by using a prospective, randomized, double-blind study.

Materials and methods The present study was conducted between January and July 2013 at the Diskapi Yildirim Beyazit Research and Education Hospital. Approval was obtained from the local Ethical Committee on 17 December 2012, 06/23 (Clinical trials identifier: NCT 01909765).

Patient selection and exclusion criteria A total of 60 American Society of Anesthesiologist (ASA) physical status IeII children, aged between 2 and 11 years, and who were scheduled for MC were included in the present study. All of the children had only cultural indications without any medical comorbidity. Children who had a history of phimosis, paraphimosis or recurrent UTI that could affect postoperative pain were excluded. Children who had a family history of malignant hyperthermia, mental retardation, and any neurological disease that was potentially associated with symptoms of agitation were excluded from the study. The children were randomized into two groups based on a coin flip. Group A was subjected to the dorsal slit technique, and Group B was subjected to the double incision (i.e. sleeve) technique. Written informed consent for the study was obtained from all parents.

124.e2 50 O2eN2O mixture. Ringer’s lactate solution was infused based on the child’s weight. During anesthesia, the children were monitored for mean arterial pressure (MAP), heart rate (HR), peripheral oxygen saturation (SPO2), and capnography. The efficacy of intraoperative analgesia was estimated based on changes in HR and MAP after surgical incision. Increases of 20% of the initial values were considered to be signs of inadequate analgesia, and such children received 1 mg/kg of IV fentanyl.

Surgery There were two surgeons who participated in this study; they both had at least 5 years of surgical experience. To avoid any surgical bias, both surgeons undertook both the sleeve and dorsal slit methods. In the dorsal slit method, the prepuce was retracted with three clamps at the 1-, 6- and 11-o’clock positions. A dorsal and vertical incision, which included both the skin and mucosa, was made at the 12-o’clock position. Gentle traction was applied to the skin and mucosa of the prepuce, and a circumferential excision was performed using scissors. In all children, hemostasis was achieved using bipolar cautery and several U sutures. The skin and mucosa were primarily sutured. In the double incision (i.e. sleeve) technique, the penile skin was circumferentially marked in its original position from the level of the coronal sulcus. Retracting the prepuce opened the mucosa. Smegma was cleaned, and then the mucosa of the glans was incised circumcisionally at a distance of 0.5 cm from the frenulum (using a No. 11 scalpel). The frenular artery was protected (Fig. 1). Following the complete incision of the mucosa, the skin was cut circumcisionally from the initially marked line. The skin and mucosa were stripped off the penis in one piece. Hemostasis was also achieved using bipolar cautery. Finally, the mucosa and skin were primarily sutured [2]. Following the completion of the surgical procedure, postoperative analgesia was provided via a dorsal penile

Anesthesia All children were premedicated with 0.5 mg/kg of oral midazolam, with a maximum dose of 15 mg. Anesthesia induction was either by inhalational, using 5-6 minimum alveolar concentration (MAC) sevoflurane in a 50/50 O2eN2O mixture, or intravenously (IV) using 2 mg/kg of propofol and 1 mcg/kg of fentanyl. Once a sufficient depth of anesthesia was achieved, a laryngeal mask airway was inserted for all children. Anesthesia was maintained using 1 MAC sevoflurane in a 50/

Figure 1 Line A: a tracing of the right branch of the frenular artery. Line B: the recommended line of incision for sparing the frenulum of prepuce.

124.e3 nerve block (DPNB) using 0.3 ml/kg of 0.5% bupivacaine (5 mg/ml Marcaine, Abbott Laboratories, Elverium, Norway). The children were all transferred to the postanesthesia care unit (PACU). Two experienced surgeons performed all regional blocks. Postoperative pain was assessed using the Modified Objective Pain Scale (MOPS) [3], in which each criterion (i.e. crying, movement, agitation, posture, and pain localization) was assessed using a 3-point scale (0e2), with a total score between 0 and 10. Pain was initially assessed at the time of arrival in the PACU and subsequently during the 1st, 4th, 8th, 12th and 24th hours post surgery. Agitation was assessed using the Ramsey Sedation Scale [4], with the following scale: 1, agitated; 2, cooperative, oriented, and calm; 3, obedient to orders only; 4, sleeping, responding to tactile or verbal stimulus. Agitation was assessed upon arrival in the PACU. The pain and agitation assessment was performed and recorded by an anesthesiologist, who was blinded to group allocation. For children with a MOPS score 4, acetaminophen (paracetamol) (Parol 10 mg/ml vial, Atabay Kimya, Istanbul, Turkey) was used at a dose of 15 mg/kg for rescue analgesia. The time from the termination of general anesthesia to the child’s first analgesic administration was defined as the pain-free (PF) period. Children with an Aldrete score >9 were transferred to the ward [5]. Once on the ward, the children were observed for pain and postanesthetic and postsurgical complications. The children were discharged when they had stable vital signs, could tolerate oral fluids, and had passed urine. Another anesthesiologist who was also blinded to group allocation assessed postoperative analgesia. The first analgesic request, all doses of supplemental analgesia and children who required no additional analgesics were recorded. The parents were also blinded to group allocation. All children were followed up to 24-h post operation.

Statistical analysis All data were evaluated using the SPSS for Windows 11.5 software program (Chicago Inc., IL, USA). The t-test was used for independent samples, in order to evaluate differences between the two groups for data with a normal distribution, and the ManneWhitney U test was used to evaluate differences between groups for data with a nonnormal distribution. The Wilcoxon test was used to determine differences in MOPS scores over time between the groups. The data were presented as the mean (SD) or the median (range) where appropriate. The results were considered to be statistically significant when the P-value was less than 0.05.

Results The ages and weights of the children included in the study were similar (Table 1). The MOPS scores were lower in Group B than in Group A at the first assessment in the PACU and during the 4th hour (P Z 0.01 and P Z 0.037, respectively). No statistically significant differences in MOPS values were measured for the 8h, 12-h and 24-h assessments (Table 1). Twelve children (40%)

N. Karakoyunlu et al. Table 1

Demographics, pain scores and Ramsey data.

Age (year) (Mean  SD) Weight (kg) (Mean  SD) MOPS recovery room Median (minemax) MOPS 1 h Median (minemax) MOPS 4 h Median (minemax) MOPS 8 h Median (minemax) MOPS 12 h Median (minemax) MOPS 24 h Median (minemax) RAMSEY Median (minemax)

Group A (n Z 30)

Group B (n Z 30)

P

5.8  1.9 22.1  5.6 3 (0e8)

6.3  2.0 22.8  7.7 2 (0e4)

0.332 0.673 0.010

3 (0e8)

2 (0e7)

0.115

1 (0e4)

1 (0e3)

0.037

0 (0e4)

0 (0e5)

0.123

0 (0e7)

1 (0e4)

0.054

0 (0e4)

0 (0e1)

0.287

2 (1e4)

3 (1e4)

0.018

MOPS, Modified Objective Pain Scale.

in Group B and 23 (76.6%) in Group A required no additional analgesia on postoperative day 1 (P Z 0.004) (Fig. 2). The time to the first analgesic request was longer in Group B than in Group A (4.57  3.10 min in Group B and 1.55  1.75 min in Group A) (P Z 0.005). The groups were similar with respect to acetaminophen consumption (Group A Z 323  83 mg vs Group B Z 300  78.4 mg) (P Z 0.918) during the 1st hour. However, six children in Group A required a second dose of analgesic on perioperative 1st day, while none in Group B needed additional analgesia (Table 2). The Ramsey sedation scores were higher in Group A than in Group B (P Z 0.018) (Table 1). No complications were observed in either group.

Discussion Postoperative pain remains a major problem after operations, despite improvements in algologic and surgical techniques. Although simple and easy to perform, MC is associated with considerable postoperative pain. Postoperative pain management in children is a necessity for both medical and ethical reasons. Pain control after MC is provided by topical analgesics, systemic administration of nonsteroidal anti-inflammatory drugs, opioid analgesics or the use of local anesthetic techniques [6]. The local anesthetic techniques that are used in combination with general anesthesia for postoperative analgesia after circumcision include DPNB, caudal block, pudental block, and topical lidocain-prilocain gel application. The DPNB is an effective technique that is frequently used in combination with the anatomic landmark technique [7,8]. Bellieni et al. [9] reviewed 14 studies and reported that the use of DPNB and acetaminophen derivatives or topical analgesic cream reduced pain dramatically, but those authors emphasized that no method completely eliminated pain [9]. In the present study, DPNB was used as the main analgesic method and the effect of different surgical techniques

Surgical circumcision procedures on postoperative pain

Figure 2

A graph of the analgesic demands.

on postoperative pain was compared. The present study demonstrated that the sleeve technique yielded lower pain scores, reduced analgesic consumption and lower agitation scores after MC than the dorsal slit technique. Male circumcision consists of the surgical removal of some or the entire foreskin (i.e. prepuce) from the penis. The blood supply to the frenulum bilaterally arises from the dorsal artery of the penis [10]. Each two branches of frenular artery pass through the ventral side of penis at the level of coronal sulcus. When it crosses the corpus spongiosum, the artery becomes more superficial (Fig. 1). During preputial surgery, the frenular artery can be injured, potentially causing ischemia in the distal urethra and glans penis. Due to this ischemia, pain and meatal stenosis can occur [11]. Dorsal slit is often the primary method in cases with paraphimosis [12]; during this procedure, the frenulum

Table 2 Total doses of postoperatively administered paracetamol between surgical techniques.

Times of the first analgesic usage hour (Pain-free period) (Mean  SD) No analgesic use for 24 h (#) One dose (#) Two doses (#) Acetaminophen consumption (mg) (Mean  SD)

124.e4

Group A (n Z 30)

Group B (n Z 30)

P

1.6  1.8

4.6  3.1

0.005

12 (40%)

23 (76.6%)

0.004

18 (60%) 6 323  83

7 (23.4%) 0 300  78.4

0. 918

frequently cannot be preserved at the 6-o’clock position of the mucosa, because of traction applied to the skin and mucosa. As a result, the frenular artery is injured. In contrast, the sleeve technique protects the frenulum and the anatomic structures of the glans. In the sleeve technique, providing hemostasis and preventing partial ischemia by protecting the frenular artery reduces postoperative pain and complications. Persad et al. [11] suggested that the preservation of the frenular artery during circumcision would reduce ischemia and meatal stenosis. This study demonstrated that the sleeve technique, which preserved the frenular artery, caused less bleeding, reduced electrocautery use and less ischemia than the dorsal slit technique. Thus, this finding can explain the reduced pain scores and analgesic consumption that were observed in Group B. Pain is an important reason for agitation. Different scales of agitation exist, such as the Riker agitationsedation scale, the Richmond sedation-agitation scale, and the Ramsey agitation-sedation scale (RASS). In the present study, the Ramsey agitation-sedation scale was used to asses emergence agitation. Although RASS is widely used to assess sedation-agitation levels in the intensive care unit, it has not been validated for assessing postoperative agitation in PACU. Combining the assessment with a different scale and by a different person might compensate for the lack of validity for the Ramsey sedation scale [13]. In the present study, pain assessment MOPS with the Ramsey scale were combined; another blinded researcher conducted this assessment. In the present study, it was found that the RASS correlated with the MOPS. In the present study, postoperative agitation was considered to be a consequence of postoperative pain. It is suggested that the agitation in the recovery room that was observed in Group A was associated with the higher pain scores of this group, despite the pain control provided by

124.e5 DPNB. Pain appears to be a promoting factor, because the administration of analgesic agents reduces its incidence [14,15]. The sleeve technique effectively reduces early postoperative pain and agitation after circumcision, provided that adequate postoperative analgesia has been achieved. While all variables except the employed surgical techniques were similar, Group B had advantages with respect to analgesic requirements and pain control during the first 8 h after the operation. Due to the design of study, which was focused on postoperative pain, there is a lack of long-term results such as meatal stenosis or chronic pain; this should be considered as a limitation. However, circumcision is not one of the surgical procedures that are associated with chronic pain.

Conclusion The sleeve technique results in lower pain scores and a reduced incidence of agitation after elective male circumcision.

Ethical approval This study was conducted between January and July 2013 at the Diskapi Yildirim Beyazit Research and Education Hospital. Approval was obtained from the local Ethical Committee on 17 December 2012, 06/23 (Clinical trials identifier: NCT 01909765).

Funding source None declared.

Conflict of interest The authors declare no conflict of interest.

N. Karakoyunlu et al.

References [1] Wiswell TE. Circumcision circumspection. N Engl J Med 1997;336: 1244e5. http://dx.doi.org/10.1056/NEJM199704243361709. [2] Hinman F, Stempen PC. Atlas of urologic surgery. Philadelphia: WB Saunders; 1998. [3] Wilson GA, Doyle E. Validation of three paediatric pain scores for use by parents. Anaesthesia 1996;51:1005. [4] Ramsay MA, Savege TM, Simpson BR, Goodwin R. Controlled sedation with alphaxalone-alphadolone. Br Med J 1974;2:656. [5] Aldrete JA. The post-anesthesia recovery score revisited. J Clin Anesth 1995;7:89. [6] Sayed JA, Fathy MA. Postoperative analgesia for circumcision in children: a comparative study of caudal block versus high dose rectal acetaminophen or EMLA cream. J Am Sci 2012;8:512. [7] Kirya C, Werthmann Jr MW. Neonatal circumcision and penile dorsal nerve blockea painless procedure. J Pediatr 1978;92: 998. [8] Faraoni D, Gilbeau A, Lingier P, Barvais L, Engelman E, Hennart D. Does ultrasound guidance improve the efficacy of dorsal penile nerve block in children? Paediatr Anaesth 2010;20: 931e6. http://dx.doi.org/10.1111/j.1460-9592.2010.03405.x. [9] Bellieni CV, Alagna MG, Buonocore G. Analgesia for infants’ circumcision. Ital J Pediatr 2013;39:38. http: //dx.doi.org/10.1186/1824-7288-39-38. [10] Hinman Jr F. The blood supply to preputial island flaps. J Urol 1991;145:1232. [11] Persad R, Sharma S, McTavish J, Imber C, Mouriquand PDE. Clinical presentation and pathophysiology of meatal stenosis following circumcision. Br J Urol 1995;75:91. [12] Williams JC, Morrison PM, Richardson JR. Paraphimosis in elderly men. Am J Emerg Med 1995;13:351. [13] Sessler CN, Grap MJ, Ramsay MA. Evaluating and monitoring analgesia and sedation in the intensive care unit. Crit Care 2008;12:S2. [14] Cravero JP, Beach M, Thyr B, Whalen K. The effect of small dose fentanyl on the emergence characteristics of pediatric patients after sevoflurane anesthesia without surgery. Anesth Analg 2003;97:364. [15] Davis PJ, Greenberg JA, Gendelman M, Fertal K. Recovery characteristics of sevoflurane and halothane in preschoolaged children undergoing bilateral myringotomy and pressure equalization tube insertion. Anesth Analg 1999;88:34e8.

Effect of two surgical circumcision procedures on postoperative pain: A prospective, randomized, double-blind study.

Male circumcision (MC) is one of the most commonly used surgical procedures worldwide for medical and traditional reasons. No studies have compared th...
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