Scolaris Content Display Scolaris Content Display

Cochrane Database of Systematic Reviews Protocol - Intervention

Sub‐Tenon's anaesthesia versus topical anaesthesia for cataract surgery

This is not the most recent version

Collapse all Expand all

Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

Primary objective
We will compare the effectiveness of topical anaesthesia (with or without the addition of intracameral local anaesthetic) and sub‐Tenon's anaesthesia in providing pain relief during cataract surgery.

Secondary objectives
We will review pain during the administration of anaesthesia, postoperative pain, surgical satisfaction with operating conditions, patient satisfaction with pain relief provided and look at any complications that occur.

Background

Cataract is defined as the loss of transparency of the natural lens of the eye, usually due to the ageing process. It can also be found in younger people secondary to congenital, drug induced, inflammatory or trauma aetiologies. Age related cataract is the most common type and causes gradual progressive loss of vision leading to blindness. Cataract is the greatest cause of blindness worldwide; approximately 20 million people are thought to be blind from cataracts (Foster 1999). In the UK 30% of people over the age of 65 have a significant cataract in one or both eyes, increasing to 71% in people over the age of 85 (Reidy 1998). It is estimated that 2.4 million people over the age of 65 in England and Wales have visually impairing cataracts (Reidy 1998; Minassian 2000). In addition it is estimated that a further 225,000 cases of visually impairing cataracts are expected each year (Minassian 2000). The only recognized treatment available for cataracts is surgery.

In the UK the recognized current best technique for cataract removal is the extracapsular technique of phacoemulsification with the implant of an intraocular lens (RCO 2004). In a national survey phacoemulsification was the method of surgery used in 77% of patients treated in the UK (Desai 1999a). In the USA 89% of cataracts are removed by phacoemulsification (Leaming 1999). The superiority of phacoemulsification over other extracapsular techniques is well established (Minassian 2001). In 2002, 270,000 phacoemulsification procedures were performed in England and Wales (RCO 2004) making it the commonest elective surgical procedure performed in the UK (RCO 2004).

Anaesthesia for cataract surgery
An ideal anaesthetic should provide pain free surgery with minimal systemic or local complications. It should be cost effective and facilitate the surgical procedure (RCO 2004). The options for anaesthesia are: general anaesthesia (Moffat 1995), local anaesthesia (Hamilton 1988) or anaesthesia free (Pandey 2001), although this is still to find acceptance by surgeons or patients due to the pain caused from the operation. Local anaesthesia can consist of periocular blocks (sub‐Tenon, peribulbar and retrobulbar), subconjunctival injection or topical with or without the addition of intracameral local anaesthesia (RCO 2004).

There has been a dramatic change of anaesthetic practice for ophthalmic surgery in the last decade. The use of local anaesthesia has risen from 20% in 1991 (Hodgkins 1992) to 86% in 1997 (Desai 1999b). Maximum health economic benefit is achieved if cataract surgery is delivered on a day care basis using local anaesthesia.

The severe risks with traditional sharp needle blocks (peribulbar and retrobulbar blocks) of globe perforation (Duker 1991), optic nerve damage (Pautler 1986), respiratory arrest (Wittpenn 1986) and even brainstem anaesthesia (Gomez 1997) have been well documented. This led to the introduction of two new techniques of anaesthesia for cataract surgery; topical anaesthesia (Fichman 1992), a needle free procedure and sub‐Tenon block (Stevens 1992), a blunt cannula procedure. Both of these have gone on to become standard for cataract surgery in the United Kingdom.

In a review of local anaesthetic techniques for cataract surgery (Friedman 2001), sub‐Tenon's anaesthesia appears to be as effective in pain control during surgery as sharp needle techniques and to be less painful on administration. This review (Friedman 2001) was limited though as they only included one trial using sub‐Tenon block and it is now dated.

The advantages of topical anaesthesia over sub‐Tenon block are time saved in administration, shorter duration of action, allowing the patient to rapidly regain sight after surgery (Kershner 1993) and less pain during the administration of anaesthesia (Friedman 2001) but there is evidence that patients report more pain intraoperatively under topical anaesthesia (Fukasaku 1994; Friedman 2001). Patients have also been shown to be less satisfied with topical anaesthesia compared with a sub‐Tenon block (Ruschen 2005) for cataract surgery. Although there is some work suggesting advantages to both techniques, there has been no recent systematic attempt to compare both techniques for all relevant outcomes.

Anaesthetic procedures

Sub‐Tenon block
A drop of local anaesthetic is placed on the eyeball to numb the front of the eye. The patient is then asked to look up and out. The conjunctiva of the eye is held with blunt forceps and a small incision is made in it with curved scissors. A small blunt sub‐Tenon's cannula is passed through this hole round towards the back of the eye, alongside the globe, and local anaesthetic is injected behind the eye, within the deep lining of the eyeball, in the sub‐Tenons space.

Topical anaesthesia
Local anaesthetic (in drop or gel form) is placed on the surface of the eye. This may be supplemented by the injection of local anaesthetic to the front chamber of the eye, intraoperatively, with a blunt needle through the operative incision (intracameral).

Rationale for a systematic review
There are published data comparing topical anaesthesia with sub‐Tenon block for cataract surgery but there remains discussion over which is the optimal technique. We are conducting this review to collate results of the different trials and to summarize the best available evidence for topical anaesthesia and sub‐Tenon block for cataract surgery. This will help guide patients, cataract surgeons, anaesthetists and healthcare managers in the choice of anaesthetic technique for surgery.

Glossary of terms
Phacoemulsification: modern, small incision, suture‐less cataract surgery
Peribulbar block: sharp needle technique with anaesthetic administered outside the orbital muscle cone at the back of the eye
Retrobulbar block: sharp needle technique with anaesthetic administered inside the orbital muscle cone at the back of the eye
Conjunctiva: the membrane lining the front of the eyeball
Subconjunctival block: anaesthetic administered under the membrane lining the eyeball

Objectives

Primary objective
We will compare the effectiveness of topical anaesthesia (with or without the addition of intracameral local anaesthetic) and sub‐Tenon's anaesthesia in providing pain relief during cataract surgery.

Secondary objectives
We will review pain during the administration of anaesthesia, postoperative pain, surgical satisfaction with operating conditions, patient satisfaction with pain relief provided and look at any complications that occur.

Methods

Criteria for considering studies for this review

Types of studies

We will include all randomized controlled trials comparing topical anaesthesia alone to sub‐Tenon's anaesthesia, either in two eyes of the same patient or different patients.

Types of participants

We will only consider studies on adult humans undergoing cataract surgery under topical or sub‐Tenon's anaesthesia.

We will exclude studies where patients have received intravenous sedation as sedation has been found to mask the pain perceived by the patient.

Types of interventions

We will include studies that compare sub‐Tenon's anaesthesia and topical anaesthesia (eye drops or gel). We will consider studies separately in which topical anaesthesia has been provided with an intracameral adjunct and analyse as a subgroup.

Types of outcome measures

Primary outcome
1. measure of pain during surgery.

Secondary outcomes
1. pain during administration of local anaesthetic;
2. postoperative pain;
3. surgical satisfaction with operating conditions;
4. patient satisfaction with analgesia provided;
5. complications that occur as defined by study authors.

The majority of trials will measure pain using the 10 point visual analogue scale but we will collect data from any study that has used a validated measurement scale.

Search methods for identification of studies

Electronic searches
We will search the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); MEDLINE (1990 to present) and EMBASE (1990 to present).

Our search strategies will be found in the Additional Tables (MEDLINE on Silver Platter: Table 1; CENTRAL: Table 2; and EMBASE on Silver Platter: Table 3)

Open in table viewer
Table 1. SilverPlatter MEDLINE (WebSPIRS) (1950 to date)

MEDLINE search term

#30 #18 and #29
#29 #25 not #28
#28 #26 not (#26 and #27)
#27 TG=humans
#26 TG=animals
#25 #19 or #20 or #21 or #22 or #23 or #24
#24 trial in TI
#23 randomly in AB
#22 (clinical trials) in MESH
#21 placebo in AB
#20 randomized in AB
#19 CLINICAL‐TRIAL in PT
#18 #8 and #17
#17 #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16
#16 block in TI, AB
#15 subtenon* or sub‐tenon* or (sub near tenon*)
#14 intra?camer* or topical* or perilimbal* or episcleral*
#13 an?esthe* and (local or intra?camer* or topical)
#12 eye drop* or eye‐drop*
#11 "Injections‐" / all SUBHEADINGS in MIME,MJME,PT
#10 (explode "Anesthesia‐Local" / all SUBHEADINGS in MIME,MJME,PT) or (explode "Anesthetics‐Local" / all SUBHEADINGS in MIME,MJME,PT)
#9 "Administration‐Topical" / WITHOUT SUBHEADINGS in MIME,MJME,PT
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7
#7 phako* or phaco*
#6 cataract* or pha?oemulsification or pha?o‐emulsification
#5 Cataract and (surg* or extract*)
#4 Cataract near(surg* or extract*)
#3 explode "Phacoemulsification‐" / all SUBHEADINGS in MIME,MJME,PT
#2 explode "Cataract‐Extraction" / all SUBHEADINGS in MIME,MJME,PT
#1 explode "Cataract‐" / all SUBHEADINGS in MIME,MJME,PT

Open in table viewer
Table 2. CENTRAL

CENTRAL Search terms

#1MeSH descriptor Cataract explode all trees
#2MeSH descriptor Cataract Extraction explode all trees
#3MeSH descriptor Phacoemulsification explode all trees
#4cataract* or phacoemulsification or phaco‐emulsification
#5phako* or phaco*
#6Cataract and (surg* or extract*)
#7Cataract near surg*
#8Cataract near extract*
#9(#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8)
#10MeSH descriptor Administration, Topical explode all trees
#11MeSH descriptor Anesthesia, Local explode all trees
#12MeSH descriptor Anesthetics, Local explode all trees
#13MeSH descriptor Injections, this term only
#14eye drop* or eye‐drop*
#15an?esthe* and (local or intra?camer* or topical)
#16intra?camer* or topical* or perilimbal* or episcleral*
#17subtenon* or sub‐tenon* or (sub near tenon*)
#18block:ti,ab
#19(#10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18)
#20(#9 AND #19)

Open in table viewer
Table 3. EMBASE 1990 to date

EMASE search terms

Search History
#36 #18 and #35(1159 records)
#35 #30 not #34(1402523 records)
#34 #32 not #33(1790170 records)
#33 #31 and #32(390489 records)
#32 (ANIMAL or NONHUMAN) in DER(2180659 records)
#31 HUMAN in DER(4389613 records)
#30 #27 or #28 or #29(2297925 records)
#29 (SINGL* or DOUBL* or TREBL* or TRIPL*) near ((BLIND* or MASK*) in TI,AB)(63160 records)
#28 (RANDOM* or CROSS?OVER* or FACTORIAL* or PLACEBO* or VOLUNTEER*) in TI,AB(366992 records)
#27 #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26(2152418 records)
#26 "SINGLE‐BLIND‐PROCEDURE"/ all subheadings(5866 records)
#25 "DOUBLE‐BLIND‐PROCEDURE"/ all subheadings(54380 records)
#24 "PHASE‐4‐CLINICAL‐TRIAL"/ all subheadings(471 records)
#23 "PHASE‐3‐CLINICAL‐TRIAL"/ all subheadings(6751 records)
#22 "MULTICENTER‐STUDY"/ all subheadings(35331 records)
#21 "CONTROLLED‐STUDY"/ all subheadings(2125578 records)
#20 "RANDOMIZATION"/ all subheadings(18941 records)
#19 "RANDOMIZED‐CONTROLLED‐TRIAL"/ all subheadings(105979 records)
#18 #8 and #17(3887 records)
#17 #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16(173262 records)
#16 block in TI, AB(71409 records)
#15 subtenon* or sub‐tenon* or (sub near tenon*)(335 records)
#14 intra?camer* or topical* or perilimbal* or episcleral*(72203 records)
#13 an?esthe* and (local or intra?camer* or topical)(30052 records)
#12 eye drop* or eye‐drop*(3663 records)
#11 "injection‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(8781 records)
#10 explode "local‐anesthesia" / all SUBHEADINGS in DEM,DER,DRM,DRR(10159 records)
#9 explode "topical‐drug‐administration" / all SUBHEADINGS in DEM,DER,DRM,DRR(29657 records)
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7(28013 records)
#7 phako* or phaco*(5119 records)
#6 cataract* or pha?oemulsification or pha?o‐emulsification(27021 records)
#5 Cataract and (surg* or extract*)(17661 records)
#4 Cataract near(surg* or extract*)(15782 records)
#3 explode "phacoemulsification‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(4005 records)
#2 explode "cataract‐extraction" / all SUBHEADINGS in DEM,DER,DRM,DRR(11517 records)
#1 explode "cataract‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(15568 records)

We will search the reference lists of identified trials to identify additional trials. We will use the Science Citation Index to find studies that have cited the identified trials.

We will not impose a language restriction in searching for publications and any article not in English will be translated.

We will not manually search any conference abstracts for this review.

Data collection and analysis

We (MD, SP) will independently review the titles and abstracts resulting from the searches. We (MD, SP) will obtain and assess the full text copies of possible and definite relevant trials according to the definitions provided in the 'Criteria for considering studies for this review'. Only trials meeting these criteria will be assessed for methodological quality. We will only include randomized trials conducted after 1990 as blunt needle sub‐Tenon's block was not described until 1992. We (MD, SP) will contact the corresponding authors for clarification of any details necessary in order to make a complete assessment of the relevance of the study. We will resolve any disagreements by consulting our arbitrator (HR).

We will assess trial quality according to the methods set out in Chapter Six of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2005). We will use four components to determine methodological quality:
1. selection bias (allocation concealment);
2. performance bias (masking of participants and researchers);
3. detection bias (persons assessing outcome);
4. attrition bias (intention to treat);

We will grade each component A: adequate, B: unclear, C: inadequate, D: not described, as outlined in the Cochrane Anaesthesia Review Group's methods and statistics guidelines. We (MD, SP) will assess the trial quality and disagreement will be resolved either by discussion or by consulting our arbitrator (HR). We will not be masked to any trial detail during the assessment. We (MD, SP) will contact the study authors if we are unable to make a decision about the classification of a study due to lack of information. We (MD, SP) will independently extract data onto forms developed by the Cochrane Anaesthesia Review Group. We (MD, SP) will compare these forms and resolve discrepancies by discussion. We (MD, SP) will double enter data into Review Manager (RevMan 4.2). We (MD, SP) will contact trialists for information about any missing data.

We (MD, SP, CB) will perform data synthesis according to the Cochrane Anaesthesia Review Group's methods and statistics guidelines. We (MD, SP, CB) will collate data from studies collecting comparable outcome measures with similar follow‐up times and assess each study for clinical and or methodological diversity by careful review of publications. We (MD, SP, CB) will consider meta‐analysis if the group of trials are sufficiently homogeneous in terms of participants, interventions and outcomes to provide a meaningful summary. We (MD, SP, CB) will assess inconsistency between trials by examining the I2 statistic (Higgins 2002). Where meta‐analysis is appropriate we will use a random effects model unless there are too few trials to allow a meaningful estimate in which case we may use a fixed effect model. Our primary outcome (and many of the secondary ones) are ordinal measurement scales. For simplicity we will assume that these are continuous and work with the standardized mean difference. For dichotomous outcomes we will present relative risks. We (MD, SP, CB) will perform a sensitivity analysis to determine the effect of including or excluding trials graded as inadequate on any parameter of quality. We will analyse trials comparing treatment in the two eyes of the same patient separately to trials comparing treatment in different patients as we have concerns regarding the validity of paired design.

Table 1. SilverPlatter MEDLINE (WebSPIRS) (1950 to date)

MEDLINE search term

#30 #18 and #29
#29 #25 not #28
#28 #26 not (#26 and #27)
#27 TG=humans
#26 TG=animals
#25 #19 or #20 or #21 or #22 or #23 or #24
#24 trial in TI
#23 randomly in AB
#22 (clinical trials) in MESH
#21 placebo in AB
#20 randomized in AB
#19 CLINICAL‐TRIAL in PT
#18 #8 and #17
#17 #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16
#16 block in TI, AB
#15 subtenon* or sub‐tenon* or (sub near tenon*)
#14 intra?camer* or topical* or perilimbal* or episcleral*
#13 an?esthe* and (local or intra?camer* or topical)
#12 eye drop* or eye‐drop*
#11 "Injections‐" / all SUBHEADINGS in MIME,MJME,PT
#10 (explode "Anesthesia‐Local" / all SUBHEADINGS in MIME,MJME,PT) or (explode "Anesthetics‐Local" / all SUBHEADINGS in MIME,MJME,PT)
#9 "Administration‐Topical" / WITHOUT SUBHEADINGS in MIME,MJME,PT
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7
#7 phako* or phaco*
#6 cataract* or pha?oemulsification or pha?o‐emulsification
#5 Cataract and (surg* or extract*)
#4 Cataract near(surg* or extract*)
#3 explode "Phacoemulsification‐" / all SUBHEADINGS in MIME,MJME,PT
#2 explode "Cataract‐Extraction" / all SUBHEADINGS in MIME,MJME,PT
#1 explode "Cataract‐" / all SUBHEADINGS in MIME,MJME,PT

Figures and Tables -
Table 1. SilverPlatter MEDLINE (WebSPIRS) (1950 to date)
Table 2. CENTRAL

CENTRAL Search terms

#1MeSH descriptor Cataract explode all trees
#2MeSH descriptor Cataract Extraction explode all trees
#3MeSH descriptor Phacoemulsification explode all trees
#4cataract* or phacoemulsification or phaco‐emulsification
#5phako* or phaco*
#6Cataract and (surg* or extract*)
#7Cataract near surg*
#8Cataract near extract*
#9(#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8)
#10MeSH descriptor Administration, Topical explode all trees
#11MeSH descriptor Anesthesia, Local explode all trees
#12MeSH descriptor Anesthetics, Local explode all trees
#13MeSH descriptor Injections, this term only
#14eye drop* or eye‐drop*
#15an?esthe* and (local or intra?camer* or topical)
#16intra?camer* or topical* or perilimbal* or episcleral*
#17subtenon* or sub‐tenon* or (sub near tenon*)
#18block:ti,ab
#19(#10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18)
#20(#9 AND #19)

Figures and Tables -
Table 2. CENTRAL
Table 3. EMBASE 1990 to date

EMASE search terms

Search History
#36 #18 and #35(1159 records)
#35 #30 not #34(1402523 records)
#34 #32 not #33(1790170 records)
#33 #31 and #32(390489 records)
#32 (ANIMAL or NONHUMAN) in DER(2180659 records)
#31 HUMAN in DER(4389613 records)
#30 #27 or #28 or #29(2297925 records)
#29 (SINGL* or DOUBL* or TREBL* or TRIPL*) near ((BLIND* or MASK*) in TI,AB)(63160 records)
#28 (RANDOM* or CROSS?OVER* or FACTORIAL* or PLACEBO* or VOLUNTEER*) in TI,AB(366992 records)
#27 #19 or #20 or #21 or #22 or #23 or #24 or #25 or #26(2152418 records)
#26 "SINGLE‐BLIND‐PROCEDURE"/ all subheadings(5866 records)
#25 "DOUBLE‐BLIND‐PROCEDURE"/ all subheadings(54380 records)
#24 "PHASE‐4‐CLINICAL‐TRIAL"/ all subheadings(471 records)
#23 "PHASE‐3‐CLINICAL‐TRIAL"/ all subheadings(6751 records)
#22 "MULTICENTER‐STUDY"/ all subheadings(35331 records)
#21 "CONTROLLED‐STUDY"/ all subheadings(2125578 records)
#20 "RANDOMIZATION"/ all subheadings(18941 records)
#19 "RANDOMIZED‐CONTROLLED‐TRIAL"/ all subheadings(105979 records)
#18 #8 and #17(3887 records)
#17 #9 or #10 or #11 or #12 or #13 or #14 or #15 or #16(173262 records)
#16 block in TI, AB(71409 records)
#15 subtenon* or sub‐tenon* or (sub near tenon*)(335 records)
#14 intra?camer* or topical* or perilimbal* or episcleral*(72203 records)
#13 an?esthe* and (local or intra?camer* or topical)(30052 records)
#12 eye drop* or eye‐drop*(3663 records)
#11 "injection‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(8781 records)
#10 explode "local‐anesthesia" / all SUBHEADINGS in DEM,DER,DRM,DRR(10159 records)
#9 explode "topical‐drug‐administration" / all SUBHEADINGS in DEM,DER,DRM,DRR(29657 records)
#8 #1 or #2 or #3 or #4 or #5 or #6 or #7(28013 records)
#7 phako* or phaco*(5119 records)
#6 cataract* or pha?oemulsification or pha?o‐emulsification(27021 records)
#5 Cataract and (surg* or extract*)(17661 records)
#4 Cataract near(surg* or extract*)(15782 records)
#3 explode "phacoemulsification‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(4005 records)
#2 explode "cataract‐extraction" / all SUBHEADINGS in DEM,DER,DRM,DRR(11517 records)
#1 explode "cataract‐" / all SUBHEADINGS in DEM,DER,DRM,DRR(15568 records)

Figures and Tables -
Table 3. EMBASE 1990 to date