Dataset Information

Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study.

ABSTRACT:

Background

To determine the safety and feasibility of sutureless pars-plana vitrectomy (ppV) in sub-Tenon anesthesia.

Methods

In this prospective study. Pain and anxiety at various times after ppV using a visual analogue scale (VAS) and Wong-Baker-FACES scale as well as visual sensations during surgery were investigated. The surgeon evaluated motility, chemosis, overall feasibility.

Results

ppV was performed on 67 eyes (33 sub-Tenon anesthesia, 34 general anesthesia). Pain during surgery in sub-Tenon anesthesia was 1.8 ± 2.2 (0.0-8.0), anxiety was 2.3 ± 2.2 (0.0-8.5). There was a moderate correlation between pain and anxiety (R² = 0.58). Comparing sub-Tenon and general anesthesia no difference in pain perception was found the day after surgery. 27.3% of patients saw details, 21.2% saw colors, 90.1% saw light/motion perception, 3.0% had no light perception. Median chemosis after surgery was 1.0 (IQR = 1.0). Median motility of the eye during surgery was 1.0 (IQR = 1.0), median grade was 1.0 (IQR = 1.0). 24.2% of patients showed subconjunctival hemorrhage during or after surgery.

Conclusions

Sutureless pars-plana vitrectomy in sub-Tenon anesthesia was performed safely, with pain and anxiety levels tolerable for the patients and without the necessity for presence of an anesthesiologist. With 88.9% of patients willing to undergo vitreoretinal surgery in sub-Tenon anesthesia again, we recommend it as a standard option. Trial registration This study was approved by the Institutional Ethical Review Board of the RWTH Aachen University (EK 111/19). This study is listed on clinicaltrials.gov (ClinicalTrials.gov identifier: NCT04257188, February 5th 2020).

SUBMITTER: Lohmann T

PROVIDER: S-EPMC10614322 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study.

Lohmann Tibor T Baumgarten Sabine S Prinz Julia J Walter Peter P Koutsonas Antonis A

European journal of medical research 20231030 1

<h4>Background</h4>To determine the safety and feasibility of sutureless pars-plana vitrectomy (ppV) in sub-Tenon anesthesia.<h4>Methods</h4>In this prospective study. Pain and anxiety at various times after ppV using a visual analogue scale (VAS) and Wong-Baker-FACES scale as well as visual sensations during surgery were investigated. The surgeon evaluated motility, chemosis, overall feasibility.<h4>Results</h4>ppV was performed on 67 eyes (33 sub-Tenon anesthesia, 34 general anesthesia). Pain ...[more]

PMID: 37899488

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Project description:PurposeTo compare pain during pars plana vitrectomy (PPV) following topical lidocaine jelly and sub-Tenon anesthesia versus peribulbar anesthesia.MethodsProspective, single-center, randomized study. Patients scheduled for PPV for macular hole (MH) or epiretinal membrane (ERM) at the Retina and Vitreous Section of the Department of Ophthalmology, Ribeirão Preto Medical School, University of São Paulo were randomly assigned to one of two groups in a 1:1 allocation ratio. Patients assigned to Group ST received topical anesthesia with 2% lidocaine jelly followed by sub-Tenon anesthesia with 2-4 ml of 1% ropivacaine. Patients assigned to PB received peribulbar anesthesia with 4-6 ml of 1% ropivacaine. After PPV, patients in both groups were asked to rate the level of pain they felt during the entire procedure (including anesthesia administration and PPV) by pointing at a 0-100 Visual Analogue Pain Scale (VAS). Data regarding demographics, patient characteristics and surgical features were also collected.ResultsFifty-four patients were enrolled in the study (26 in Group ST and 28 in Group PB). Baseline characteristics, including age, gender, and presence of comorbidities, were similar in both groups. The surgery performed was PPV alone in 10 and 14 patients in the ST and PB groups, respectively, and combined phacoemulsification and PPV in 16 and 14 patients in the ST and PB groups, respectively (p = 0.39, Pearson). Surgery duration (mean ± SD minutes) was similar in the two groups (62 ± 12 for ST and 70 ± 20 for PB, p = 0.09, t-Test). No patients needed supplemental topical or intravenous anesthesia during surgery. No sight- or life-threatening complication was observed in either group. VAS score was significantly lower in the ST compared to the PB group (median (interquartile range) was 1 (2.25-0) in the ST group compared to 11.5 (29.75-5) in the PB group, p< 0.0001, Wilcoxon).ConclusionIn this study of patients who underwent PPV for MH or ERM, topical followed by sub-Tenon anesthesia was more effective in controlling pain during the whole vitrectomy procedure than peribulbar anesthesia. Compared to peribulbar anesthesia which is administered with a sharp needle, sub-Tenon anesthesia administered with a blunt cannula may be associated with a reduced risk of such adverse events as globe perforation, retrobulbar hemorrhage, and inadvertent injection of anesthesia into the optic nerve sheath.

Project description:AimTo compare the efficacy and safety of trans-sub-Tenon's ciliary nerve block anesthesia and transcutaneous retrobulbar anesthesia in patients undergoing pars plana vitrectomy (PPV).MethodsA prospective, randomized, double-blinded clinical trial was conducted at Zhongda Hospital, Affiliated with Southeast University, from February 2021 to October 2021. Patients undergoing PPV were randomly allocated into two groups: the trans-sub-Tenon's anesthesia group (ST group) and the retrobulbar anesthesia group (RB group) in the ratio of 1:1. The ST group received 2 ml ropivacaine through the Tenon capsule to the retrobulbar space, while the RB group received 2 ml ropivacaine via transcutaneous retrobulbar injection. Visual analog score (VAS) was used to evaluate pain during the whole process, including during anesthesia implementation, intraoperatively and on the first day after the operation. Movement evaluation (Brahma scores) and anesthesia-related complications were also noted.ResultsFinally, a total of 120 patients were included in the study (60 in the ST group and 60 in the RB group). There were no significant differences in baseline patient characteristics or surgical features between the two groups. The VAS pain scores for anesthesia implementation were 0.52 ± 0.47 in the ST group and 1.83 ± 0.87 in the RB group (P < 0.001). The VAS scores during the operation were 0.53 ± 0.49 in the ST group and 1.48 ± 1.02 in the RB group (P < 0.001) and those on the first day after the operation were 0.37 ± 0.38 in the ST group and 0.81 ± 0.80 in the RB group (P = 0.002). No patients required supplemental intravenous anesthesia intraoperatively. The Brahma movement scores were 0.70 ± 1.64 in the ST group (scores ranging from 0 to 8) and 2.38 ± 3.15 in the RB group (ranging from 0 to 12) (P = 0.001). Forty-two patients in each group received laser photocoagulation during surgery. Fifteen patients (36%) in the ST group could not see the flashes of the laser, compared to 8 patients (19%) in the RB group (P = 0.087). No serious sight-threatening or life-threatening complications related to anesthesia were observed in either group.ConclusionsFor PPV, trans-sub-Tenon's ciliary nerve block anesthesia was more effective in controlling pain than transcutaneous retrobulbar anesthesia during the whole surgery process, including during anesthesia implementation, intraoperatively and on the first day after the operation. Additionally, it could achieve better effect of akinesia and was relatively safe. Trans-sub-Tenon's anesthesia could be considered an alternative form of local anesthesia during vitreoretinal procedures.Trial registrationThe study protocol has been registered at ChiCTR.org.cn on February 2021 under the number ChiCTR2100043109 .

Project description:BackgroundThe vitreous is the clear jelly of the eye and contains fine strands of proteins. Throughout life the composition of this vitreous changes, which causes the protein strands in it to bundle together and scatter light before it reaches the retina. Individuals perceive the shadows cast by these protein bundles as 'floaters'. Some people are so bothered by floaters that treatment is required to control their symptoms. Two major interventions for floaters include Nd:YAG laser vitreolysis and vitrectomy. Nd:YAG laser vitreolysis involves using laser energy to fragment the vitreous opacities via a non-invasive approach. Vitrectomy involves the surgical replacement of the patient's vitreous (including the symptomatic vitreous floaters) with an inert and translucent balanced salt solution, through small openings in the pars plana.ObjectivesTo compare the effectiveness and safety of Nd:YAG laser vitreolysis to pars plana vitrectomy for symptomatic vitreous floaters.Search methodsWe searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 12), MEDLINE Ovid (1946 to 17 January 2017), Embase Ovid (1947 to 17 January 2017), LILACS (Latin American and Caribbean Health Sciences Literature Database) (1982 to 17 January 2017), the ISRCTN registry (www.isrctn.com/editAdvancedSearch); searched 17 January 2017, ClinicalTrials.gov (www.clinicaltrials.gov); searched 17 January 2017 and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en); searched 17 January 2017. We did not use any date or language restrictions in the electronic searches for trials. We also searched conference proceedings to identify additional studies.Selection criteriaWe included only randomised controlled trials (RCTs) that compared Nd:YAG laser vitreolysis to pars plana vitrectomy for treatment of symptomatic floaters.Data collection and analysisWe planned to use methods recommended by Cochrane. The primary outcome we planned to measure was change in vision-related quality of life from baseline to 12 months, as determined by a vision-related quality of life questionnaire. The secondary outcomes we planned to measure were best corrected logMAR or Snellen visual acuity at 12 months for the treated eye(s) and costs. Adverse outcomes we planned to record were the occurrence of sight-threatening complications by 12 months (asymptomatic retinal tears, symptomatic retinal tears, retinal detachment, cataract formation, and endophthalmitis).Main resultsNo studies met the inclusion criteria of this review.Authors' conclusionsThere are currently no RCTs that compare Nd:YAG laser vitreolysis with pars plana vitrectomy for the treatment of symptomatic floaters. Properly designed RCTs are needed to evaluate the treatment outcomes from the interventions described. We recommend future studies randomise participants to either a Nd:YAG laser vitreolysis group or a vitrectomy group, with participants in each group assigned to either receive treatment or a sham intervention. Future studies should follow participants at six months and 12 months after the intervention. Also they should use best corrected visual acuity (BCVA) using an Early Treatment of Diabetic Retinopathy Study (ETDRS) chart read at 4 metres, vision-related quality of life (VRQOL), and adverse outcomes as the outcome measures of the trial.

Dataset Information

Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study.

Background

Methods

Results

Conclusions

Publications

Safety and feasibility of sutureless pars-plana vitrectomy in sub-Tenon anesthesia (SAFE-VISA): a prospective study.

Similar Datasets

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