Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures

Figures & data

Table 1 Summary of prospective randomized controlled trials comparing lidocaine gel with another anesthetic modality

Author	N	Product tested	Procedure	Control	Endpoint	Secondary measure	Pvalue
Busbee et al^Citation27	209	Akten 1.5%/2.5%/3.5%	Conjunctival pinching with 3 mm forceps	Sham gel	Pt reported anesthesia within 5 minutes: 88% of subjects (Akten 1.5% group)/89% (Akten 2.5% group)/92% (Akten 3.5% group)/22% (sham)	Duration of anesthesia: 10.2 min (Akten 1.5%)/11.7 min (Akten 2.5%)/13.4 min (Akten 3.5%)/2.8 min (sham)	<0.001 for all groups vs sham
Barequet et al^Citation8	25	Lidocaine gel 2%	Cataract extraction	Tetracaine drops	Cochet-Bonnet esthesiometer (score 0–6, 0 = total anesthesia, 6 = pain): before instillation, 5 minutes post instillation, post surgery. Lidocaine group: 6/0/0. Tetracaine drops group: 5/0/0	Need for additional gtts (17% gel group vs 31% drops group)	<0.01 (need for additional drops)
Young et al^Citation17	40	Lidocaine gel 2%	Primary pterygium excision + MMC	Tetracaine drops + solcoseryl eye gel	VPS (0–10): during and after surgery. No sig difference between groups except during conj closure [0.47 ± 0.84 (gel group) vs 1.43 ± 1.66 (tetracaine drops group)]	No of additional gtts needed (0.16 ± 0.11 vs 0.67 ± 0.09)	<0.03 (pain), <0.001 (need for additional drops)
Theocharis et al^Citation23	69	Lidocaine gel 2%	25 g and 23 g sutureless vitrectomy	Peribulbar anesthesia	VAS pain scale, intraoperative and postoperative. No stastically significant difference in pain between groups	Surgeon-reported “ease of surgery” under topical conditions (0–10 scale): (23 g easier than 25 g, P < 0.001)	= 0.3 (pain)
Friedman et al^Citation21	100	Lidocaine gel 2%	Intravitreal injection (30 g)	Subconj lidocaine 2%	VAS pain scale, masked. No sig difference in pain between groups	None	= 0.1 (pain)
Oksuz et al^Citation15	45	Lidocaine gel 2%, applied regularly in post op period	Primary pterygium excision, post-op	Artificial tear gel, applied regularly in postop period	VAS pain scale: 4th hour post surgery: 4.13 ± 1.86 (lidocaine gel) vs 6.50 ± 1.47 (artificial tear gel); 10th hour post surgery: 2.39 ± 0.89 vs 3.63 ± 1.00	Mean corneal re-epithelialization time (no sig difference)	<0.001 (post op pain)
Kozak et al^Citation22	16	Lidocaine gel 2%	Intravitreal injection (27.5 g)	Subconj lidocaine 2%	VAS pain scale, masked. No sig difference in pain between groups	None	= 0.82
Thill et al^Citation13	39	Lidocaine gel 2% + intracameral lidocaine 1%	Cataract extraction	Bupivacaine 0.5% + oxybuprocaine + diclofenac × 4 drops	VAS pain scale, significantly lower pain scores reported in lidocaine gel group	None	<0.001
Oksuz et al^Citation16	54	Lidocaine gel 2%	Primary pterygium excision + autograft	Subconj lidocaine 2%	VAS pain scale. Pain during administration: 0.92 ± 0.56 vs 4.26 ± 1.18. Pain during surgery: 3.96 ± 0.95 vs 4.0 ± 1.01)	None	<0.01, = 0.55
Rebolleda et al^Citation18	32	Lidocaine gel 2%	Ahmed glaucoma implant	Retrobulbar injection	VAS pain scale. Pain during administration: significantly more in retrobulbar group. Intraoperative pain: no significant difference	Mean duration of surgery: significantly longer in topical group (P = 0.049)	<0.0001 (pain with administration), = 0.317 intraop pain)
Soliman et al^Citation12	90	Lidocaine gel 2%	Cataract extraction	Bupivacaine 0.5%, benoxinate 0.4%	VPS pain scale (0–10). At instillation: 2.97 (gel group)/1.53 (bupivacaine group)/1.03 (benoxinate group). Mean duration of pain at instillation: 25 s (gel)/14 s (bupivacaine)/6 s (benoxinate). Mean VPS during surgery: 1.6 (gel)/4.1 (bupivacaine drops)/7.1 (benoxinate drops)	Incidence of supplemental sub-Tenon’s injection: 3.3% (gel group)/10.0% (bupivacaine)/73.3% (benoxinate). Overall pt satisfaction: 93.3%/83.3%/33.3%	<0.001 for all comparison groups
Bardocci et al^Citation7	107	Lidocaine gel 2%	Cataract extraction	Lidocaine 4% drops	Intraoperative pain (VAS, 0–10) significantly higher in drops group, intracameral lidocaine concentration significantly higher in gel group	Intraoperative blood pressure increases (significantly higher in gtts group). No correlation found between intracameral lidocaine levels and pain score	<0.001 (pain); <0.001 (intracameral lidocaine concentration)
Yu et al^Citation25	14	Lidocaine gel 2%	Strabismus, bilateral symmetric	Amethocaine 1% in contralateral eye	VPS (0–10) during surgery: 2.6 (gel) vs 5.3 (amethocaine drops). Surgeon perception of patient discomfort (0–10): 3.2 (gel) vs 6.2 (amethocaine)	Mean no of additional drops needed: 0.3 (gel) vs 1.6 (amethocaine)	<0.01 (pain), = 0.02 (need for additional drops)
Li et al^Citation26	57	Lidocaine gel 2%	Chalazion excision	Subconj lidocaine 2%	VPS (0–100) at application of anesthetic: 5.5 (gel) vs 47.0 (subconj injection). VPS during surgery 48.28 (gel) vs 51.4 (subconj lidocaine)	“fear of injection” (pt reported, scale 0–100) 43.9 (gel) vs 47.7 (subconj injection) (P = 0.668)	<0.001 (pain with administration), = 0.679 (intraop pain)
Zabriskie et al^Citation19	36	Topical anesthesia	Trabeculectomy	Retrobulbar injection	VAS pain scale, intraoperative and postoperative. No stastically significant difference in pain between groups	Supplemental anesthesia required (no sig difference)	= 0.3

Abbreviations: MMC, mitomycin C; VAS, visual analogue scale; VPS, verbal pain score.

Table 2 Summary of nonrandomized prospective studies of lidocaine gel 2% in various surgical situations

Author	N	Product tested	Procedure	Endpoint	Secondary measure	Notes
Leung et al^Citation14	33	Lidocaine gel 2%	Primary pterygium excision + conj autograft	VPS pain scale (0–4), during and 15 minutes after surgery. During surgery: 84% reported pain score 2 or lower; 15 minutes post-op, 82% reported pain score 2 or lower	Need for additional anesthetic: 57% required no additional anesthetic, 43% required additional drops alone, none required subconjunctival injection
Kwok et al^Citation10	41	Lidocaine gel 2%	Cataract extraction	Duration of application vs intracameral lidocaine concentration by HPLC. Longer duration of application significantly associated with higher aqueous concentrations	VPS pain scale (0–10). No correlation between duration of application or aqueous lidocaine concentration with pain score
Kwok et al^Citation28	20	Lidocaine 2%	Laser procedures	VPS pain scale (0–4). 95% of patients reported score of 1 or less, 75% with score of 0	None	Gel noted to be a good coupling medium for laser lenses
Assia et al^Citation6	100	Lidocaine gel 2%	Cataract extraction (48 ECCE, 52 phaco)	VAS pain scale, ECCE: 0.99 ± 1.64, phacebo: 0.72 ± 1.47	None	Surgeons report better instrument lubrication during surgery
Lai et al^Citation20	22	Lidocaine gel 2%	Combo phaco/trab	VAS pain scale (0–10), intraoperative: mean 0.9 (range 0–3)	Intraoperative vital signs: no significant increase in BP or pulse rate. No additional anesthetic required
Segev et al^Citation24	15	Topical lidocaine 2% intracameral anesthesia + iv sedation	PKP (repeat)	VPS pain scale (0–3) preoperatively, intraoperatively, and postoperatively: Mean intraoperative VPS 0.51 ± 0.32, mean postoperative VPS 0.46 ± 0.50	Pt satisfaction (subjective report, 0–5 scale): mean 4.67. Surgeon satisfaction (0–5): mean 4.67. 14/15 preferred topical to retrobulbar (which they had for previous PKP)

Abbreviations: ECCE, extracapsular cataract extraction; HPLC, high-performance liquid chromatography; PKP, penetrating keratoplasty; VAS, visual analogue scale; VPS, verbal pain score.

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