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Li-Quan Zhao, MD, Huang Zhu, MD, Pei-Quan Zhao, MD, Qi-Rong Wu, MD, Yi-Qian Hu, MD
Purpose: To examine possible differences in the clinical outcomes of topical anesthesia (TA) and regional anesthesia including retrobulbar anesthesia (RBA) and peribulbar anesthesia (PBA) in phacoemulsication. Design: Systematic review and meta-analysis. Participants: Patients from previously published randomized controlled trials (RCTs) of phacoemulsication under TA and RBA/PBA reporting clinical outcomes. Methods: A comprehensive literature search was performed according to the Cochrane Collaboration method to identify RCTs that compare TA and RBA/PBA in phacoemulsication. Main Outcome Measures: Primary outcome parameters investigated were pain score during and after surgery, intraoperative difculties and inadvertent ocular movement, intraoperative necessity to administer additional anesthesia, and patient preference. Secondary outcome parameters investigated were postoperative visual acuity, anesthesia-related complications, intraoperative complications, and severe local or systemic complications. Results: Fifteen studies were identied and analyzed to compare TA (1084 eyes) with RBA/PBA (1121 eyes) in phacoemulsication. Data synthesis showed that intraoperative and postoperative pain perception was signicantly higher in the TA group (P 0.05). The TA group showed more frequent inadvertent ocular movement (P 0.05) and a greater intraoperative need for supplementary anesthesia (P 0.03). There was no statistically signicant difference between the 2 groups in intraoperative difculties as assessed by the surgeons (P 0.05). Patients signicantly preferred TA (P 0.00001). The RBA/PBA group had more frequent anesthesia-related complications, such as chemosis, periorbital hematoma, and subconjunctival hemorrhage (P 0.05). There was no statistically signicant difference in surgery-related complications (P 0.05). Conclusions: Compared with RBA/PBA, TA does not provide the same excellent pain relief in cataract surgery; however, it achieves similar surgical outcomes. Topical anesthesia reduces injection-related complications and alleviates patients fear of injection. The choice of TA is not suitable for patients with a higher initial blood pressure or greater pain perception. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Ophthalmology 2012;119:659 667 2012 by the American Academy of Ophthalmology.
In developed countries, phacoemulsication with intraocular lens implantation is the current standard of care procedure for adult cataract surgery.1 In 2005 and 2006, a national survey covering 287 000 cataract extractions was carried out in the United Kingdom, showing that 99.7% of the adult patients were treated with phacoemulsication.2 Cataract removal has developed into a rapid turnover daycase procedure as it has become faster, safer, and less traumatic.3 The anesthetic techniques available for adult cataract surgery evolved simultaneously.4 Retrobulbar anesthesia (RBA), peribulbar anesthesia (PBA), and topical anesthesia (TA) are most commonly applied in cataract surgery today. Since its introduction in 1993, TA has been widely accepted.5 A recent British national survey found that TA is administered by 33% of cataract surgeons6 (up from 4.1% in 19967 and 20.9% in 20038), particularly those undertaking high-volume surgery. Topical anesthesia was reported to be more cost-effective and safer than regional anesthesia (including RBA/PBA) in terms of anesthesiarelated complications.3,9
2012 by the American Academy of Ophthalmology Published by Elsevier Inc.
In the literature comparing TA with RBA/PBA in phacoemulsication, inconsistencies exist on the outcomes and conclusions.10 26 Therefore, an in-depth review and meta-analysis of the available studies can further clarify the benets of TA and RBA/PBA in phacoemulsication. We incorporated RBA and PBA into 1 group because the meta-analysis by Alhassan et al27 showed that these 2 methods have similar anesthetic and clinical effects in cataract surgery. The meta-analysis by Ezra et al28 showed that TA supplemented with intracameral lidocaine reduces more intraoperative pain in cataract surgery under TA compared with TA alone. For this reason, we omitted studies referencing TA supplemented with intracameral lidocaine. We systematically searched for existing randomized controlled trials (RCTs) that compared TA with RBA/PBA in cataract surgery. We then reviewed the selected studies in detail and carried out a meta-analysis to identify any clinical differences between the 2 anesthetic techniques. The primary objective was to assess pre- and postoperative pain, intraoperative difculties, inadvertent ocular motion, need for additional anesthesia during surgery, and patients preferred anesthetic
ISSN 0161-6420/12/$see front matter doi:10.1016/j.ophtha.2011.09.056
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method. The secondary objective was to assess adverse effects and complications attributable to the anesthetic techniques.
Literature Search
Two reviewers (L-QZ and HZ) independently searched the PubMed, EMBASE, and Cochrane Controlled Trials Register databases for publications up to July 6, 2010. To maximize the data search and identify all RCTs that compared TA with RBA/PBA in phacoemulsication, we used the following text terms: topical anesthesia or drop anesthesia, retrobulbar anesthesia or block, peribulbar anesthesia or block, regional or local anesthesia or block, periocular or periocular anesthesia, cataract surgery, cataract extraction, and phacoemulsication. We reviewed the abstracts of related titles and retrieved the full articles if their title or abstract appeared to meet this reviews objectives. To identify studies not found by computerized search,
Table 1. Characteristics of the 15 Randomized Controlled Trials Investigating Topical versus Retrobulbar
No. of Patients (M/F); Mean Age (yrs) SD (Range) 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 27 (11/16); 65.67.9 27 (11/16); 65.57.9 58 (20/38); 7410 57 (20/37); 7210 155 (97/57); 57.48.5 151 (76/74); 57.28.0 49 (22/27); 73.6 (4690) 58 (28/30); 73.8 (5088) 238 (88/150); 73.15.6 238 (84/154); 72.16.8 69 (4585) 69 (4585) 45 (4580) 45 (4580) Eyes (Dropouts) 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 27 (0) 27 (0) 58 (0) 57 (0) 155 (1) 151 (1) 49 (0) 58 (0) 238 (0) 238 (0) 69 (0) 69 (0) 45 (0) 45 (0) 71 (0) 69 (0) 49 (0) 51 (0) 45 (0) 45 (0) 36 (0) 36 (0) 27 (0) 27 (0) 136 (0) 163 (0) 35 (0) 41 (0) 44 (1) 44 (1) Intervention (Topical Drops) 2% lidocaine 2% oxybuprocaine 0.5% proparacaine 2% lidocaine 2% lidocaine 0.75% bupivacaine 0.75% bupivacaine
Trial (Location) Topical vs. Retrobulbar Ryu et al 2009 (Korea)10 Gombos et al 2007 (Hungary)11 Rengaraj et al 2004 (India) Chan et al 2002 (China)13 Jacobi et al 2000 (Germany)14 Patel et al 1996 (US)15 Patel et al 1998 (US)16 Topical vs. Peribulbar Sauder and Jonas 2003 (Germany)17 Virtanen and Huha 1998 (Finland)18 Roman et al 1996 (France)19 Zehetmayer et al 1996 (Austria)20 Strobel and Hhnermann 1996 (Germany) Uusitalo et al 1999 (Finland)22 Topical vs. Retrobulbar/Peribulbar Chung et al 2004 (China)23 Nielsen and Allerd 1998 (Denmark)24
21 12
1-: 71; 73.21.4 2-: 69; 74.11.9 1-: 49 (15/34); 67.3 (2480) 2-: 51 (16/35); 66.6 (3780) Total: 45 (17/28); 73 Total: 36 (15/21) 1-: 2-: 1-: 2-: 1-: 2-: 1-: 2-: 27 (15/12); 71.3 (5287) 27 (18/9); 68.5 (2686) 136; 72.2 (3389) 163; 71.3 (3093) 35 (11/24); 41 (22/19); 44 (21/23); 44 (15/29); 70.210.8 75.07.8 79 (5393) 77 (5991)
2% lidocaine 4% lidocaine
1- topical group; 2- control group (retrobulbar or peribulbar); IV intravenous; F female; GSA graded subjective assessment; M male;
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Outcome Measures
The primary outcome parameters investigated by this study were (1) measures of pain during and after the surgery, (2) measures of intraoperative difculties and inadvertent eye movement, (3) need for additional anesthesia during surgery, and 4) patient preference for type of anesthesia. The secondary outcome parameters investigated by this study were (1) postoperative visual acuity; (2) anesthesia-related complications, including chemosis, periorbital hematoma, subconjunctival hemorrhage, postoperative nausea and vomiting, and postoperative analgesia; (3) intraoperative complications, including capsule rupture with or without loss of vitreous, zonular tear, and iris prolapse; and (4) severe local or systemic complications, such as endophthalmitis, respiratory depression, and cardiopulmonary arrest.
Statistical Analysis
The quantitative data of the outcome parameters were entered into the Cochrane Review Manager (RevMan) version 4.2 software program and analyzed. Summary estimates and 95% condence intervals (CIs) were calculated. For continuous outcome data (e.g., pain score), the weighted mean difference or standardized mean difference was calculated by mean and standard deviations. For dichotomous outcomes (e.g., proportions of anesthesia-related complications), the Peto odds ratio was calculated. To identify statistical heterogeneities, the Cochran Q-Statistics chi-square test and inconsistency index (I-squared, I2) were applied. When no signicant evidence of statistical heterogeneity
Control (Injection Drugs) 2% lidocaine hyaluronidase 2% lidocaine 0.5% bupivacaine 2% lidocaine adrenaline hyaluronidase 2% lignocaine 0.5% bupivacaine hyaluronidase 2% lidocaine 0.5% bupivacaine hyaluronidase 2% lidocaine 0.75% bupivacaine hyaluronidase 2% lidocaine 0.75% bupivacaine hyaluronidase 2% mepivacaine hyaluronidase 2% lidocaine 0.5% bupivacaine hyaluronidase 2% lidocaine 0.5% bupivacaine 2% lidocaine 0.5% bupivacaine hyaluronidase 2% lidocaine 0.5% bupivacaine 2% lidocaine 0.75% bupivacaine hyaluronidase 2% lignocaine 2% lidocaine 0.5% bupivacaine hyaluronidase No
Sedation
Incision Clear cornea Clear cornea Clear cornea Clear cornea/scleral tunnel Clear cornea Clear cornea Clear cornea
Pain Score VAS (0100) GSA (01) NR NR VAS (010) VAS (010) VAS (010)
Jadad Score 4 3 5 3 4 3 4
Oral alprazolam for all No No Oral midazolam for RBA IV methohexital IV fentanyl, if IV methohexital IV fentanyl, if No Sedation was given to 3 patients in TA and 4 in PBA (drug not reported) IV fentanyl or propofol for PBA; IV propofol for TA if necessary Oral meprobamate for all NR IV fentanyl for all; IV midazolam, if needed for RBA; IV midazolam for TA; necessary for RBA; IV midazolam for TA; necessary
Sclerocorneal Scleral pocket Clear cornea Clear cornea Clear cornea Clear cornea
VAS (010) VAS (010) GSA (04) VAS (0100) GSA (04) VAS (010)
3 3 3 5 3 6
No No
NR VAS (0100)
3 3
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or clinical diversity could be established, xed-effects models were used. However, results showing signicant heterogeneity (I2 50%) were subjected to a random-effects meta-analysis applying the DerSimonian-Laird method. In addition, outcome measures were assessed on an intent-to-treat basis. A P value of less than 0.05 was considered statistically signicant.
Results
The present meta-analysis encompasses 15 RCTs involving 2205 eyes that had undergone phacoemulsication under TA, RBA, or PBA.10 24 The 15 studies and their quality assessment are summarized in Table 1.
Primary Outcomes
Pain Score. Twelve studies reported pain outcome measurements.10,11,14 22,24 To measure pain experienced, 3 studies used a 0to 100-mm visual analog scale with a numeric rating scale;10,20,24 6 studies used a visual analog scale with numeric and descriptive ratings from 0 (no pain) to 10 (severe pain).14 18,22 All the above outcomes were presented as continuous outcome data (mean and standard deviation). Three studies used subjective assessment on a scale of 0 (no pain) to 3 (much pain) or 4 (intense pain),19,21,24 and 1 study merely recorded the presence or absence of pain.11 We transformed the data of these 4 studies into dichotomous data by dividing them into 2 groups scoring 0 (no pain) or 1 (pain experienced). Twelve studies scored intraoperative pain.10,11,14 22,24 The synthesis of their continuous data showed that patients receiving TA experienced signicantly greater intraoperative pain than patients receiving RBA (P 0.03). In contrast, there was no statistically signicant difference between the TA group and the PBA subgroup (P 0.07); however, there was an obvious trend of more pain perceived by the patients receiving TA. Overall, the data showed that the TA group perceived statistically signicantly greater pain (P 0.003) (Fig 1). In conrmation, the dichotomized data also showed that patients receiving TA had signicantly more pain than those receiving RBA/PBA (P 0.00001) (Table 2). From this, it can be inferred that RBA/PBA can reduce pain in patients under anesthesia.
Figure 1. Forest plot comparing the mean pain score during surgery with TA and RBA/PBA. CI condence interval; PBA peribulbar anesthesia; RBA retrobulbar anesthesia; SD standard deviation; SMD standardized mean difference; TA topical anesthesia.
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CI condence interval; PBA peribulbar anesthesia; RBA retrobulbar anesthesia; TA topical anesthesia.
Need for Additional Anesthesia during Surgery. The need for supplemental anesthesia during surgery was reported by 8 studies.1317,19,20,22 The types of additional anesthesia administered varied greatly. They included PBA, TA, subconjunctival injections, sub-Tenons anesthesia, and intravenous sedation. Among the studies, there was no consistency in the type and administration of supplemental anesthesia. In the interest of our study, we therefore selected the cases of regional anesthesia by injection, which covered 1412 randomized eyes in the assessed trials. The meta-analysis showed that signicantly more patients receiving TA were in need of supplementary anesthesia compared with those receiving RBA/PBA (P 0.03) (Table 2). Preference of Anesthesia. Four studies reported bilateral cataract surgery in which the patients had TA in 1 eye and RBA/PBA in the other eye. In addition, they recorded the proportion of patient preference for either of the 2 anesthetic techniques.15,19,22,24 Our analysis showed a statistically significantly greater preference for TA (P 0.00001) (Table 2).
Secondary Outcomes
Postoperative Visual Acuity. Three studies reported postoperative visual acuity.11,21,22 Within the scope of the 3 studies, preoperative visual acuity showed no signicant difference between the 2 groups. Gombos et al11 demonstrated no statistically signicant difference in visual acuity between the groups on the rst day after surgery (Snellen chart).11 Strobel and Hhnermann21 showed that visual acuity was not signicantly different in the patients of either group 5 hours, 1 day, and 2 days postoperatively (no details of data were given).21 Uusitalo et al22 indicated that the 2 groups did not differ in their proportions of patients reaching a 20/40 visual acuity 4 months after surgery. Because the studies applied no uniform standard to assess visual acuity, we abstained from performing a meta-analysis. Anesthesia-Related Complications. Conjunctival chemosis, periorbital hematoma, and subconjunctival hemorrhage were more frequent in the RBA/PBA group than in the TA group
Figure 2. Forest plot comparing the mean postoperative pain score with TA and RBA/PBA. CI condence interval; PBA peribulbar anesthesia; RBA retrobulbar anesthesia; SD standard deviation; SMD standardized mean difference; TA topical anesthesia.
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Figure 3. Forest plot comparing the intraoperative difculties of TA and RBA/PBA as assessed by the surgeons. CI condence interval; PBA peribulbar anesthesia; RBA retrobulbar anesthesia; SD standard deviation; SMD standardized mean difference; TA topical anesthesia.
(P 0.05) (Table 2). Postoperative nausea and vomiting, and the postoperative need for analgesics occurred more often in the TA group. According to the reported data, the incidence of postoperative nausea and vomiting was more than 3-fold greater in the TA group (3/76) than in the RBA/PBA group (1/85).10,13 However, on analysis there was no overall statistically significant difference between the 2 groups with respect to postoperative nausea and vomiting (P 0.23) (Table 2). Likewise, there was no overall statistically signicant difference between the 2 types of anesthesia in the postoperative need for analgesics (P 0.14) (Table 2). Intraoperative Complications. Thirteen studies reported intraoperative complications, such as posterior capsule rupture with or without vitreous loss, zonular tear, and iris prolapse.1122,24 However, synthesis of these data showed no statistically signicant differences between the 2 anesthetic techniques (P 0.05) (Table 2). Severe Local or Systemic Complications. The 2 trials by Patel et al15,16 recorded 2 cases of retrobulbar hemorrhage in patients receiving RBA (1/69 patients and 1/45 patients, respectively). Globe perforation did not occur in any of the selected trials. Uusitalo et al22 reported that 2 cases of endophthalmitis developed in the TA group (2/136). Ryu et al10 recorded adverse hemodynamic effects: One patient (1/27) in the TA group and 1 patient (1/27) in the RBA group developed bradycardia; 0 patients (0/27) in the TA group and 15 patients (15/27) in the RBA group developed tachycardia; 3 patients (3/27) in the TA group and 12 patients (12/27) in the RBA group developed hypertension.10 No major systemic complications, such as respiratory depression, oxygen desaturation, or cardiopulmonary arrest, were reported in any of the trials.
Discussion
The 15 trials included in this meta-analysis compared in detail the clinical outcomes of TA with those of RBA/ PBA.10 24 Twelve of the trials applied different methods to measure patient discomfort; they also reported different
outcomes and drew different conclusions. The synthesis of all the continuous and dichotomous data showed a statistically signicantly greater intraoperative and postoperative pain perception in the TA group, with one exception: There was no statistically signicant difference in the intraoperative pain scores between the TA group and the PBA subgroup. Eight trials recorded the necessity to administer supplementary anesthesia by regional anesthetic injection in the course of phacoemulsication.1317,19,20,22 The results of the meta-analysis showed that the use of TA resulted in a signicant trend of an increased need for supplementary anesthesia. This trend is likely to reect the higher pain scores and more frequent inadvertent eye movement in the TA group. However, given the poor denition and heterogeneity of the criteria applied to the pain score measurement and the need for supplemental regional anesthetic injection during surgery, this result should be interpreted with caution. Nevertheless, this conclusion is convincing in connection with the different ranges of anesthetized area covered by TA and regional anesthesia such as RBA and PBA. In phacoemulsication, regional anesthesia by injection can achieve lid akinesia, globe akinesia, and total ocular anesthesia. In contrast, TA seems to effect a partial ocular anesthesia. Consequently, in the absence of intracameral anesthesia, the iris is not anesthetized by TA. Therefore, surgery might stimulate pain receptors, particularly if surgical instruments touch the iris, resulting in patient discomfort. As a result, supplemental regional anesthesia by injection might be requested by the surgeon or patient. To offset the subjectivity of pain scores, some trials applied objective parameters to compare the differences in pain score.10,11 Pain perception in the TA group caused blood pressure, heart rate, and serum adrenaline levels to increase. In contrast, patients receiving regional anesthesia by injection required a smaller total amount of patient-controlled seda-
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visual acuity than the RBA group; 1 day and 1 week after surgery, there was no difference in visual acuity between the groups.26 Randomized controlled trials focusing on short-term visual rehabilitation are needed to support this conclusion. Other trials indicated that both TA and regional anesthesia were associated with a low incidence of postoperative nausea and vomiting in routine phacoemulsication.10,13 However, there was no statistically signicant difference in postoperative nausea and vomiting between the 2 anesthetic techniques. The use of systemic sedation described in some of these studies is important. Kallio et al35 demonstrated that intravenous sedation by propofol added to TA did not improve the operative conditions or surgical outcome. In addition, during and after surgery, sedatives did not improve the pain score of patients receiving TA compared with patients receiving TA without sedation. Of course, clinicians will be aware that any single RCT should be interpreted with caution. The administration of sedation did not follow a standard procedure throughout the studies. In addition, the number of studies was insufcient for a subgroup meta-analysis. Therefore, we did not perform a sensitivity analysis excluding the trials reporting systemic sedation. The heterogeneity between the included trials reporting anesthesia with or without the use of sedation did not need to be taken into consideration for the validity of the present study. We hope more RCTs investigating the exclusive relationship between systemic sedation and regional anesthesia in phacoemulsication will be performed to answer the question of whether sedatives improve the pain score and operative conditions. In conclusion, although TA does not provide pain relief as effectively as RBA/PBA during cataract surgery, its anesthetic effect is nevertheless reasonably well tolerated by patients. Similar surgical outcomes were achieved by TA and RBA/PBA. Topical anesthesia reduced injection-related complications and alleviated patients fear of injections. The choice of TA is not suitable for specic patients. In patients with a higher initial blood pressure and younger patients who are more susceptible to pain, TA alone should be avoided and alternative anesthetic methods are recommended.11 Today, there are numerous anesthetic techniques from which a surgeon can choose. However, there is not one type of anesthesia that is right for all potential cases. The best choice may vary from surgeon to surgeon on the basis of experience and predilection, and from patient to patient.
References
1. Allen D, Vasavada A. Cataract and surgery for cataract. BMJ 2006;333:128 32. 2. Jaycock P, Johnston RL, Taylor H, et al, UK EPR user group. The Cataract National Dataset electronic multi-centre audit of 55,567 operations: updating benchmark standards of care in the United Kingdom and internationally. Eye (Lond) 2009;23: 38 49. 3. Navaleza JS, Pendse SJ, Blecher MH. Choosing anesthesia for cataract surgery. Ophthalmol Clin North Am 2006;19: 2337.
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Department of Ophthalmology, Xinhua Hospital Afliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China. Financial Disclosure(s): The author(s) have no proprietary or commercial interest in any materials discussed in this article. Funding: Grants from the Shanghai Leading
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