Evaluation of Duration of Anesthesia and Patient Satisfaction After Retrobulbar Block Applied in Cataract Surgery

It is aimed to determine patient satisfaction (pain assessment during and after the operation) and the initial and total anesthesia durations of eye lid and globe anesthesia after administration of local anesthetic solution only in standard applied volumes (1.5-3 ml). No agents will be added to the local anesthetic agents used in the conventional retrobulbar block in patients who will undergo cataract surgery,

Study Overview

• Status: Unknown
• Conditions: Anesthesia, Local; Patient Satisfaction; Anesthesia Recovery Period; Cataract Surgery; Anesthesia; Adverse Effect; Akinesia
• Intervention / Treatment: Drug: Lidocaine 2% Injectable Solution 0.75 ml; Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml; Drug: Lidocaine 2% Injectable Solution 1.5 ml; Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml

Detailed Description

In this study, 80 patients with American Society of Anesthesiologists (ASA) I-II-III who accepted retrobulbar anesthesia before cataract surgery and who were over 18 years of age and under 90 years of age were included in the study. Not accepting local anesthesia, being under 18 years of age, having problems in communication, having eyelid or eye anomaly, having Parkinson's disease, myopia with axial length ≥ 26 mm, hypersensitivity to local anesthetics or other drugs, and bleeding or other drug-induced clotting problem were determined as exclusion criteria for the investigator's study.

Written informed consent will be obtained from patients eligible for the study according to the above criteria. While obtaining informed consent, it will also be verbally stated that this study does not include any risks other than the risks of standard cataract surgery and retrobulbar block.

Patients taken to the operating room before the operation will be monitored and baseline blood pressure, pulse and peripheral capillary oxygen saturation (SpO2) values will be recorded. 2lt / min oxygen will be administered to patients with a nasal cannula. The normal ocular and valve movements of the patient will be checked and recorded before the procedure. Patients will receive a 20 gauge intravenous (IV) cannula. Before the retrobulbar block is applied, topical anesthesia is provided with 0.5% proparacaine drops and field cleaning with povidone iodine will be performed. The patient will be instructed to look at the finger held by the assistant personnel to bring the eyeball to the neutral position and the local anesthetic mixture will be slowly injected into the retrobulbar area with a 25 gauge ophthalmic needle. For retrobulbar anesthesia, 1.5-3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients. The maximum treatment duration is 1 day and single dose. Gently massage the eye to disperse the local anesthetic solution and reduce bleeding. After block 1, 3, 5 and 10 minutes ocular movements and valve movements will be evaluated. To do this, patients will be told to look up, down, right and left and be asked to squeeze and open their eyelids. Ocular movements will be scored for each direction separately if normal, 2 if slightly restricted, and 0 if there is no movement (total score 0-8) [1]. In the evaluation of eye lid movements, complete immobility will be scored as 0, partial movement as 1 and normal movement as 2 [2]. The patient's blood pressure, pulse and SpO2 values will be recorded at 5 min intervals throughout the operation. During the operation, the pain of the patients will be assessed by a 3-point scale (0: no pain; 1: uncomfortable; 3: pain). Postoperative ocular and eye lid akinesia scores of the patients will be recorded at 30-minute intervals. Ocular and eye lid akinesia times will be recorded. Any side effects that occur during and after the procedure will be recorded. One day later, patients' responses will be recorded by asking for the first time and the number of times they need analgesics.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Turkey
  • Kayseri
    • Develi, Kayseri, Turkey, 38400
      • Develi Hatice Muammer Kocatürk Devlet Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

80 people will be included in the study. All adult patients of ASA (American Society of Anesthesiologists) I-II-III who accept retrobulbar anesthesia before cataract surgery will be included in the study.

The study will not include a vulnerable population, such as people with disabilities, children, pregnant women, puerperants and nursing women, people in intensive care and unconscious, and those who cannot give consent in person or vulnerable subjects.

Description

Inclusion Criteria:

1. To accept retrobulbar anesthesia before cataract surgery
2. To be over 18 and under 90
3. Being ASA I-II-III

Exclusion Criteria:

1. Not to accept local anesthesia
2. To be under 18 years
3. Having problems in communication
4. To have lid or eye anomaly
5. Being Parkinson's
6. Being myopia with axial length ≥ 26 mm
7. Hypersensitivity to local anesthetics or other drugs
8. Having bleeding or other drug related clotting problems

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1.5 ml Dose; For retrobulbar anesthesia, 1.5 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.	Drug: Lidocaine 2% Injectable Solution 0.75 ml; 0.75 ml of Lidocaine will be added to the anesthetic solution.; Other Names: Lidocaine; Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml; 0.75 ml of Bupivacaine will be added to the anesthetic solution.; Other Names: Bupivacaine
3 ml Dose; For retrobulbar anesthesia, 3 ml of local anesthetic solution (2% lidocaine, 5% bupivacaine) will be administered to the patients.	Drug: Lidocaine 2% Injectable Solution 1.5 ml; 1.5 ml of Lidocaine will be added to the anesthetic solution.; Other Names: Lidocaine; Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml; 1.5 ml of Bupivacaine will be added to the anesthetic solution.; Other Names: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Pain Score	patient pain assessed by with pain score of 3 points-scale (0 No pain,1 Not comfortable, 2 Have pain )	Immediately after the surgery
The scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 1 minutes after the block
The scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 3 minutes after the block
The scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 5 minutes after the block
The scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 10 minutes after the block
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 30 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 60 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 90 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 120 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 150 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 180 minutes after the operation
The postoperative scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 210 minutes after the operation
The scores of ocular and eyelid movements	Ocular movements will be scored separately for each direction, 2 if normal, 1 if slightly restricted and 0 if no movement. Complete inactivity will be scored as 0, partial movement as 1, and normal movement as 2 in the evaluation of eyelid movements.	at 240 minutes after the operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The need for analgesic and how many times it needs	The patients will be asked whether they need analgesia (yes or no), if they need analgesia, they will be asked what time and how many times they take analgesic agents.	One day after the surgery
side effects questionnaire	Ophthalmic side effects (Globe perforation, Pain at the injection site, Pressure sensation behind the eye, Subconjunctival hemorrhage, Retrobulbar hemorrhage, hematoma, ecchymosis, diplopia, ptosis) and other side effects (Nausea and vomiting, arrhythmia, Convulsion, Allergy, Weakness)	One day after the surgery

Collaborators and Investigators

• Sponsor: Develi Devlet Hastanesi
• Investigators: Principal Investigator: Gamze ALBAYRAK, MD, Develi Devlet Hastanesi

Publications and helpful links

General Publications

• Barr J, Kirkpatrick N, Dick A, Leonard L, Hawksworth G, Noble DW. Effects of adrenaline and hyaluronidase on plasma concentrations of lignocaine and bupivacaine after peribulbar anaesthesia. Br J Anaesth. 1995 Dec;75(6):692-7. doi: 10.1093/bja/75.6.692.
• Sarvela PJ. Comparison of regional ophthalmic anesthesia produced by pH-adjusted 0.75% and 0.5% bupivacaine and 1% and 1.5% etidocaine, all with hyaluronidase. Anesth Analg. 1993 Jul;77(1):131-4. doi: 10.1213/00000539-199307000-00026.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 16, 2019
• Primary Completion (Anticipated): April 24, 2020
• Study Completion (Anticipated): April 24, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 23, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Cataract; Patient Satisfaction; Anesthesia Recovery Period; Pain Score; Retrobulbar Block; Ocular and eyelid; Akinesia
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Pharmaceutical Solutions; Bupivacaine
• Other Study ID Numbers: 2019/776

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No