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ORIGINAL ARTICLE
Year : 2013  |  Volume : 20  |  Issue : 3  |  Page : 221-224  

A single drop of 0.5% proparacaine hydrochloride for uncomplicated clear corneal phacoemulsification


Department of Ophthalmology, Shri Vasantrao Naik Government Medical College, Yavatmal, Maharashtra, India

Date of Web Publication9-Jul-2013

Correspondence Address:
Rajesh Subhash Joshi
77, Panchtara Housing Society, Manish Nagar, Somalwada, Nagpur - 440 015, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0974-9233.114795

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   Abstract 

Purpose: The purpose of this study was to compare the efficacy of a single drop of 0.5% proparacaine hydrochloride in uncomplicated cataract surgery with phacoemulsification.
Materials and Methods: Two hundred and ninety five patients scheduled for the phacoemulsification were divided into 2 groups based on the anesthetic agents they were to receive: 146 patients who received a single drop of 0.5% proparacaine 2 min before the start of the surgery (proparacaine group) and; 149 patients who received supplementation of 0.5% intracameral preservative free xylocaine (xylocaine group). A single surgeon performed all surgeries. Intraoperative and post-operative pain scores were evaluated on a visual analog scale. The surgeon noted his subjective impression of corneal clarity, discomfort while performing the surgery any supplemental anesthesia required and intraoperative complications. An anesthetist noted vital parameters and the need for intravenous sedation. Total surgical time was noted. Comparison of parameters was performed with the Chi-square test, and A P value less than 0.05 was considered as statistically significant.
Results: No statistically significant difference was seen in the intraoperative (P = 0.24) and post-operative (P = 0.164) pain scores between groups. There was no pain (0 score) in 41.8% of patients in the proparacaine group and 46.3% of patients in the xylocaine group. The average surgical time (P = 0.279) and surgeon discomfort (P = 0.07) were not statistically significantly different between groups. No patients required supplemental anesthesia. There were no surgical complications that could compromise the visual outcome. An equal number of patients in both groups preferred same type of anesthetic technique for the fellow eye cataract surgery (89.11% for the proparacaine group and 90.18% for the xylocaine group). No patients in either group had changes in vital parameters or required intravenous sedation.
Conclusion: A single drop pre-operatively, of proparacaine hydrochloride was comparable to the intracameral supplementation of preservative free xylocaine for phacoemulsification in uncomplicated cataract surgery without compromising the visual outcome. However, we recommend individualizing the anesthetic technique according to the requirements of the surgeon.

Keywords: Intracameral Lidocaine, Phacoemulsification, Proparacaine Group Topical Anesthesia, Visual Analog Scale


How to cite this article:
Joshi RS. A single drop of 0.5% proparacaine hydrochloride for uncomplicated clear corneal phacoemulsification. Middle East Afr J Ophthalmol 2013;20:221-4

How to cite this URL:
Joshi RS. A single drop of 0.5% proparacaine hydrochloride for uncomplicated clear corneal phacoemulsification. Middle East Afr J Ophthalmol [serial online] 2013 [cited 2019 Jun 25];20:221-4. Available from: http://www.meajo.org/text.asp?2013/20/3/221/114795


   Introduction Top


Phacoemulsification is the method of choice for most ophthalmologists for cataract removal. Advances in phaco machines, fluidics and viscoelastics have made cataract surgery faster, less traumatic with greater technical control for the surgeon. The developments of self-sealing clear corneal incision and topical anesthesia have allowed faster functional recovery post-operatively. Topical anesthesia is the safe and effective alternative to peribulbar and retrobulbar anesthesia for phacoemulsification. [1],[2]

Lidocaine 4%, bupivacaine 0.5%, benoxinate 0.4%, and proparacaine 0.5%H drops have been evaluated as topical anesthetic agents during cataract surgery. However, frequent instillation of these drops pre-operatively can lead to corneal clouding intraoperatively. Preservative free intracameral xylocaine can be delivered as a supplement to topical anesthesia to minimize intraoperative patient discomfort. However, a study has shown intracameral administration of xylocaine has no clinically useful role during phacoemulsification. [3] In addition, some reports have cautioned cataract surgeons regarding the potential corneal endothelial injury of anesthetic agents injected into the eye. [4],[5],[6]

The present study prospectively compared to the effectiveness of instilling a single drop of 0.5% proparacaine hydrochloride during the phacoemulsification to intracameral 0.5% preservative free xylocaine as a supplement to topical proparacaine.


   Materials and Methods Top


Approval of the study was obtained from the ethical committee of the hospital. Written informed consent was obtained from each patient. This prospective, randomized, and comparative study comprised 295 patients scheduled for phacoemulsification. Patients with operable cataracts of various grades were included in this study. [7] The exclusion criteria were allergy to the topical anesthetics, deafness, nystagmus, barrier to the communication, extreme anxiety, neurological disorders, monocular patients, complicated and subluxated cataracts, non-dilating pupil and patients unable to understand a visual analog scale (VAS).

Pre-operatively, all patients had routine ophthalmic evaluation. Patients were randomized into two groups based on anesthetic agents they were to receive: the proparacaine group was comprised of the patients who received a single drop of proparacaine hydrochloride (Paracain, Sunways Pvt. Ltd., India), placed in the lower fornix, 2 min before the start of the surgery; the xylocaine group was comprised of patients who received a single drop of proparacaine 2 min before the surgery and supplemented with intracameral 0.5% preservative free xylocaine (xylocaine, Astra Zeneea Ltd., India). Pre-operatively, the pupils were dilated with topical phenylephrine 2.5% and topical tropicamide 0.8% (Appamide, Appasamy Ocular Devices, Puducherry, India). No non-steroidal anti-inflammatory drugs were used pre-operatively. No patients received pre-operative or intraoperative sedation.

Surgical technique

All surgeries were performed by one surgeon. No superior rectus suture was taken. A universal eye speculum was used in all cases. Patients were instructed to fixate on the microscope light during surgery. A side port incision was created on the appropriate side to stabilize the globe. A 3.2 mm clear corneal temporal incision was performed through, which viscoelastic (2% Hydroxypropyl methyl cellulose, Appavisc, Appasamy Ocular Devices, Puducherry, India) was injected. A 5.5 mm wide capsulorhexis was created using utrata forceps. Complete cortical cleaving hydrodissection was performed by injecting a balanced salt solution between the lens capsule and the cortex with a 27-gauge cannula. The nucleus was divided using a direct chop technique. Parameters were vacuum 350 cc, flow rate 33 cc, and power 40-70 based on the grade of the nucleus in a pulse mode (Swisstech, Oertli phacoemulsification system, Switzerland). Cortical cleanup was performed with the irrigation/aspiration probe. A single piece hydrophobic or hydrophilic intraocular lens based on the patient choice was implanted in the bag. The viscoelastic material was removed from the capsular bag and from the anterior chamber. Stromal hydration of the side port and main incision was performed. No sutures were required in any case.

The duration of the surgery was recorded by the accompanying surgeon. Time of surgery (duration) was recorded from the creation of the side port incision to the completion of stromal hydration.

No patients received intracameral miotics intraoperatively or subconjunctival injection at the completion of the surgery. After completion of surgery, patients were taken to the recovery room. A standard 10-point VAS was used to assess intraoperative and post-operative pain. [8] Post-operative pains were assessed 30 min after the completion of the surgery. A trained para-ophthalmic technician performed the pain grading procedure. The surgeon was not presented during the assessment of the pain score. The patient was also asked whether they would be going for similar anesthetic technique for the fellow eye cataract surgery.

The surgeon's subjective impression of corneal haze (grade 0 = clear, 1 = mild haze, 2 = moderate haze, 3 = severe haze), discomfort during the surgery (grade 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain), complications and supplemental anesthesia were recorded.

The anesthetist also noted vital parameters such as blood pressure, pulse rate, and oxygen saturation intraoperatively and the need for supplemental intravenous sedation.

Comparison of parameters was performed with the Chi-square test. A P value less than 0.05 was considered statistically significant.


   Results Top


The study included 295 eyes of 295 patients. There 146 patients were in proparacaine group and 149 patients in the xylocaine group. There were 146 females (proparacaine group n = 71, xylocaine group n = 75) and 149 males (proparacaine group n = 75, xylocaine group n = 74).

The mean age in the proparacaine group was 61.00 ± 11.09 years and 58.71 ± 10.09 years the xylocaine group. Nine patients (3.05%) had grade 1, 34 patients (11.53%) had grade 2, 150 patients (50.85%) had grade 3 and 102 (34.58%) patients had grade 4 nuclei.

The average intraoperative pain score on the VAS in the proparacaine group was 1.171 ± 1.50 (range, 0-7) and 0.986 ± 1.433 (range, 0-7) in the xylocaine group (P = 0.24). Zero score (i.e., no pain) was reported by 41.8% of patients in the proparacaine group and 46.3% of patients in the xylocaine group. The mean post-operative pain score was 0.9246 ± 1.0769 in the proparacaine group and 0.7465 ± 0.9742 in the xylocaine group (P = 0.164).

The average surgical time was 6.470 ± 1.106 min in the proparacaine group and 6.913 ± 4.450 min in the xylocaine group (P = 0.279). The average corneal haze during surgery was 0.0616 ± 0.315 in the proparacaine group and 0.1438 ± 0.4547 in the xylocaine group (P = 0.56).

No patients required supplemental anesthesia. No pupillary manipulation was required during any stage of the surgery. There were no surgical complications, which could compromise the visual outcome. The average surgeon discomfort score was 0.178 ± 0.507 in the proparacaine group and 0.102 ± 0.402 in the xylocaine group ( P = 0.07).

In the proparacaine group, 101 (69.18%) patients had bilateral cataract and 89.11% of patients considered the same anesthetic technique for the fellow eye surgery. In the xylocaine group, 112 (90.18%) patients had bilateral cataracts and 90.18% of patients considered same anesthetic technique for the fellow eye surgery.

Average blood pressure was systolic 130 ± 5 mmHg and diastolic 85 ± 3 mHg for both groups collectively. Average pulse rate was 78 ± 4 oxygen saturation was maintained at 99-100% for both group collectively. No patients in either group had changes in vital parameters or required intravenous sedation.


   Discussion Top


Our study showed that pre-operative instillation of a single drop of proparacaine hydrochloride provided satisfactory patient comfort for safe phacoemulsification with implantation of intraocular lens in all grades of cataracts. There was no significant difference in intraoperative pain scores between groups. The VAS score in the proparacaine group was 1.171 ± 1.50, which is less than reports from other studies on phacoemulsification under topical anesthesia with repeated applications. Agarwal et al. reported average VAS score of 1.44 ± 1.04 in patients who underwent cataract surgery with 4% xylocaine. [9] Tsoumani et al. reported a VAS score of 4.19 ± 2.321) in patients who underwent cataract surgery with 0.5% tetracaine. [10] Soliman et al. reported a verbal pain score of 1.53 ± 0.29 in patients who underwent cataract surgery with 0.5% bupivacaine. [11] The VAS score in proparacaine group in our study was equivalent to score in patients who received supplemental intracameral xylocaine in Agarwal et al.'s study (1.16 ± 1.17). [9]

Prior to starting this study, we investigated optimal protocol for instillation of proparacaine hydrochloride. A single application was sufficient when applied 2-3 min prior to the surgery when patient was taken to the operation theater table.

Single or multiple instillations of lidocaine 2% gel has been reported to provide excellent anesthesia during phacoemulsification. [12],[13] This is due to the prolonged contact of the anesthetic agent to the corneal epithelium. However, corneal epithelial safety of the gel form of the lidocaine has not been fully investigated. Our study proves that instillation of a single drop of proparacaine is comparable to single or multiple instillations of lidocaine gel in terms of the patient and surgeon comfort. [12],[13]

Post-operative VAS scores and surgeons comfort while performing the surgery was similar between groups. The safety of the single drop application of proparacaine was indicated by the observation that no patient required supplemental anesthesia or intravenous sedation during the procedure. There were no visually significant intraoperative complications or corneal haze. The average surgical time in both groups was almost equal (proparacaine group = 6.470 min and xylocaine group = 6.913 min). An almost equal number of patients in both groups preferred same type of anesthetic for the fellow eye (proparacaine group = 89.11% patients and xylocaine group = 90.18% patients).

However, the surgeon's expertise and experience are key factors in performing phacoemulsification in patients with the minimal anesthesia. This study involves a single surgeon. Including two or more surgeons with different expertise may provide stronger conclusions for this study.


   Conclusion Top


The study results demonstrate phacoemulsification can be performed with a single drop instillation of proparacaine hydrochloride 2 min pre-operatively without compromising the visual outcome in all grades of cataracts. Pain experience and surgeon comfort was comparable in both groups. The ease of application, lack of toxicity, and sufficient effect to complete the surgery makes it an efficient alternative in uncomplicated clear corneal phacoemulsification. However, it is prudent to individualize the anesthetic technique according to the patient and surgeon need.


   Acknowledgment Top


We thank Dr. Niraj Prasad, anesthetist, Dr. Anumeha Jindal, assistant surgeon, for their kind help during the study period. Dr. Minal Kulkarni for the statistical analysis.

 
   References Top

1.Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg 1996;22:612-4.  Back to cited text no. 1
    
2.Patel BC, Burns TA, Crandall A, Shomaker ST, Pace NL, van Eerd A, et al. A comparison of topical and retrobulbar anesthesia for cataract surgery. Ophthalmology 1996;103:1196-203.  Back to cited text no. 2
    
3.Gillow T, Scotcher SM, Deutsch J, While A, Quinlan MP. Efficacy of supplementary intracameral lidocaine in routine phacoemulsification under topical anesthesia. Ophthalmology 1999;106:2173-7.  Back to cited text no. 3
    
4.Liang C, Peyman GA, Sun G. Toxicity of intraocular lidocaine and bupivacaine. Am J Ophthalmol 1998;125:191-6.  Back to cited text no. 4
    
5.Behndig A, Lindén C. Aqueous humor lidocaine conc entrations in topical and intracameral anesthesia. J Cataract Refract Surg 1998;24:1598-601.  Back to cited text no. 5
    
6.Judge AJ, Najafi K, Lee DA, Miller KM. Corneal endothelial toxicity of topical anesthesia. Ophthalmology 1997;104:1373-9.  Back to cited text no. 6
    
7.Parson JH, Miller SJ. The lens. In: Sinhota R, Tandon R, editors. Parsons' Diseases of the Eye. 21 st ed. New Delhi: Elsevier Publishers; 2011. p. 270.  Back to cited text no. 7
    
8.Stevens JD. A new local anesthesia technique for cataract extraction by one quadrant sub-Tenon's infiltration. Br J Ophthalmol 1992;76:670-4.  Back to cited text no. 8
    
9.Pandey SK, Werner L, Apple DJ, Agarwal A, Agarwal A, Agarwal S. No-anesthesia clear corneal phacoemulsification versus topical and topical plus intracameral anesthesia. Randomized clinical trial. J Cataract Refract Surg 2001;27:1643-50.  Back to cited text no. 9
    
10.Tsoumani AT, Asproudis IC, Damigos D. Tetracaine 0.5% eyedrops with or without lidocaine 2% gel in topical anesthesia for cataract surgery. Clin Ophthalmol 2010;4:967-70.  Back to cited text no. 10
    
11.Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: Lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg 2004;30:1716-20.  Back to cited text no. 11
    
12.Barequet IS, Soriano ES, Green WR, O'Brien TP. Provision of anesthesia with single application of lidocaine 2% gel. J Cataract Refract Surg 1999;25:626-31.  Back to cited text no. 12
    
13.Koch PS. Efficacy of lidocaine 2% jelly as a topical agent in cataract surgery. J Cataract Refract Surg 1999;25:632-4.  Back to cited text no. 13
    



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