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

NCT04178200 | Unknown

• 1 other identifier: 2019/776
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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,

Conditions

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

Keywords

Cataract; Retrobulbar Block; Ocular and eyelid; Akinesia; Anesthesia Recovery Period; Patient Satisfaction; Pain Score

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (2)

• The need for analgesic and how many times it needs

  One day after the surgery

• side effects questionnaire

  One day after the surgery

Study Arms (2)

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; Drug: Bupivacaine Hcl 0.5% Inj 0.75 ml

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; Drug: Bupivacaine Hcl 0.5% Inj 1.5 ml

Interventions

Lidocaine 2% Injectable Solution 0.75 ml DRUG

0.75 ml of Lidocaine will be added to the anesthetic solution.

Also known as: Lidocaine

1.5 ml Dose

Bupivacaine Hcl 0.5% Inj 0.75 ml DRUG

0.75 ml of Bupivacaine will be added to the anesthetic solution.

Also known as: Bupivacaine

1.5 ml Dose

Lidocaine 2% Injectable Solution 1.5 ml DRUG

1.5 ml of Lidocaine will be added to the anesthetic solution.

Also known as: Lidocaine

3 ml Dose

Bupivacaine Hcl 0.5% Inj 1.5 ml DRUG

1.5 ml of Bupivacaine will be added to the anesthetic solution.

Also known as: Bupivacaine

3 ml Dose

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• To accept retrobulbar anesthesia before cataract surgery
• To be over 18 and under 90
• Being ASA I-II-III

You may not qualify if:

• Not to accept local anesthesia
• To be under 18 years
• Having problems in communication
• To have lid or eye anomaly
• Being Parkinson's
• Being myopia with axial length ≥ 26 mm
• Hypersensitivity to local anesthetics or other drugs
• Having bleeding or other drug related clotting problems

Sponsors & Collaborators

• Develi Devlet Hastanesi: lead

Study Sites (1)

Develi Hatice Muammer Kocatürk Devlet Hastanesi

Develi, Kayseri, 38400, Turkey (Türkiye)

Location

Related 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. doi: 10.1093/bja/75.6.692.

  PMID: 8672315 BACKGROUND

• 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.

  PMID: 8317720 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Cataract

Interventions

Lidocaine; Bupivacaine

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gamze ALBAYRAK, MD

  Develi Devlet Hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hastane Başhekimliği

CONTACT

+903526216020; kayseridhs2@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Specialist Doctor

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: December 16, 2019
• Primary Completion: April 24, 2020
• Study Completion: April 24, 2020
• Last Updated: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)