Cataract surgeries, Phacoemulsification, Subtenon block, Ropivacaine, Bupivacaine
Conditions
Interventions
64 patients with cataract were admitted for phacoemulsification and intraocular lens implantation with an average duration of 30 minutes. These participants were randomly allocated into two groups wit
Drug
E03.155.086.231
Sponsors
Hospital Alberto Rassi - HGG
Fundação Banco de Olhos de Goiás
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Volunteers aged between 18 and 75 years; physical status I or II according to ASA (American Society of Anesthesiologists) criteria; both sexes; candidates for phacoemulsification facectomy surgery and intraocular lens implantation with episcleral block
Exclusion criteria
Exclusion criteria: Volunteers with known allergy to local anesthetic; glaucoma patients; abnormal eye movement; chronic cough; anticoagulant therapy; orbital abnormalities; inability to understand study information; block failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome expected: motor akinesia quality assessed by motor block quality assessment (degree of akinesia) will be done through the Nicoll scale, in which the eyeball is schematically divided into quadrants and the motor block in each quadrant evaluated with graduation from 0 to 2 points. Being 0, complete motion; 1 - partial movement and 2 - absence of movement (akinesia). The motor block intensity of the extrinsic musculature of the ocular globe will be given by the sum of the quadrants and may vary from 0 to 8. A block with a score greater than 6 is considered adequate. Motor block will be evaluated in four moments - before (T0), 5 minutes (T5) and 10 minutes (T10) after subtenonian blockade. In cases of inadequate motor block after 10 minutes, a dose of 2 mL of 1% ropivacaine will be administered by peribulbar inferior puncture before the start of surgery or subtenon supplementation with 2% lidocaine by the surgeon, and these patients will be excluded from the study.;Primary outcome found: within 10 minutes, akinesia was adequate in 84.38% of the Ropivacaine group and in only 62.50% of the Bupivacaine group (p = 0.048). | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome 1: Postoperative analgesia was assessed by visual analogue pain scale ranging from 0 (no pain) to 10 (unbearable pain). The analgesia research will be performed 30 minutes after the end of the surgery and 24 hours after the blockade (through telephone contact). The need for postoperative supplemental analgesia will be questioned during the telephone contact.;Secondary outcome found 1: There was no difference in postoperative pain between groups;Expected secondary outcome 2: Sedation level was assessed using the Ramsay Sedation Scale ranging from level 1 (anxious or agitated patient) to 6 (no response to the stimulus).;Secondary outcome found 2: There was no difference in the level of sedation between groups;Expected secondary outcome 3: Intraocular pressure (IOP), was evaluated by means of a manual aplanation tonometer in four moments - before (T0), 5 minutes (T5) and 10 minutes (T10) after subtenonian blockade.;Secondary outcome found 3: In both groups (GR-Group Ropivacaine and GB-Group Bupivacaine), increase in IOP compared to baseline, for T5 (difference in GR = 3.28 ± 0.85 vs GB = 1.31 ± 0.89, p = 0.000) and T10 (difference in GR = 2.78 ± 1.01 vs. GB = 0.66 ± 0.93, p = 0.000), being higher in RG, with statistical significance. Statistically significant differences between the groups were also observed in the evaluation of IOP in T10 (GR = 15.44 ± 1.52 vs GB = 14.59 ± 1.79, p = 0.047);Expected secondary outcome 4: Adverse effects, the occurrence of side effects such as sedation, bradycardia (decrease in heart rate greater than 20% of pre-blocking values), hypotension (defined as a decrease in mean arterial pressure of more than 20% of values before the blockade) and hypoxia (SpO2 <90% in ambient air) during the operation.;Secondary outcome found 4: There was no difference in the occurrence of adverse events between groups. However, in the analysis by isolated comorbidities, a higher frequency of bradycardia in GB was observed when compa | — |
Countries
Brazil
Contacts
Public ContactDenismar Miranda
Pontifícia Universidade Católica de Goiás
Outcome results
None listed