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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04178200
• Other study ID #: 2019/776
• Status: Not yet recruiting
• Start date: December 16, 2019
• Est. completion date: April 24, 2020

Study information

• Verified date: November 2019
• Source: Develi Devlet Hastanesi
• Contact: Hastane Bashekimligi
• Phone: +903526216020
• Email: kayseridhs2[@]saglik.gov.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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,

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 24, 2020
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Akinesia
• Anesthesia Recovery Period
• Anesthesia, Local
• Anesthesia; Adverse Effect
• Cataract
• Cataract Surgery
• Patient Satisfaction

Intervention

Drug:
• Lidocaine 2% Injectable Solution 0.75 ml
0.75 ml of Lidocaine will be added to the anesthetic solution.
• Bupivacaine Hcl 0.5% Inj 0.75 ml
0.75 ml of Bupivacaine will be added to the anesthetic solution.
• Lidocaine 2% Injectable Solution 1.5 ml
1.5 ml of Lidocaine will be added to the anesthetic solution.
• Bupivacaine Hcl 0.5% Inj 1.5 ml
1.5 ml of Bupivacaine will be added to the anesthetic solution.

Locations

Country	Name	City	State
Turkey	Develi Hatice Muammer Kocatürk Devlet Hastanesi	Develi	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Develi Devlet Hastanesi

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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