Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?

NCT04036201 | Completed

• 1 other identifier: FMASU R 41/2019
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to calculate the minimum effective volume of local anesthetic for peribulbar block in patients undergoing cataract extraction surgery.

Conditions

Peribulbar Block

Keywords

Peribulbar block; minimum effective volume; axial eye length

Outcome Measures

Primary Outcomes (1)

• The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.

  The minimum effective volume of local anesthetic in peribulbar block in relation to the eyeball axial length.The minimum volume which will achieve adequate sensory and motor block within 10 minutes.

  10 minutes

Study Arms (2)

Group 1(22-24 mm)

EXPERIMENTAL

Group 1 (patients with axial length between 22 and 24 mm): received a mixture of bupivacaine 0.5% (3ml) + lidocaine 2% (3ml) + hyalurindase 150 IU (1 ml) to a total volume of 7 ml.

Drug: Bupivacaine

Group 2(24.1-26 mm)

EXPERIMENTAL

Group 2 (patients with axial length between 24.1 and 26 mm): received a mixture of bupivacaine 0.5% (3ml) + lidocaine 2% (3ml) + hyaluronidase 150 IU (1 ml) to a total volume of 7 m

Drug: Bupivacaine

Interventions

Bupivacaine DRUG

peribulbar block

Also known as: hyaluronic acid

Group 1(22-24 mm); Group 2(24.1-26 mm)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• we allocated adult patients aged 40-70 years, of both gender, American Society of Anesthesiologists (ASA) II - III, listed for elective cataract extraction using phaco emulsification technique with intraocular lens implantation surgery.

You may not qualify if:

• Patients known to have any systemic contraindications (as severe hypertension) or allergy to the local anesthetic, those who refused local anesthesia, high myopes (axial length \> 26 mm), patients with a single eye, those with complicated vitreous hemorrhage, ocular infection, or associated glaucoma have been excluded.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine ,Ain Shams University

Cairo, Cairo Governorate, 11566, Egypt

Location

Related Publications (1)

• El Fawal SM, Nofal WH, Sabek EAS, Abdelaal WA. Minimum effective volume of local anesthetic in peribulbar block: does it differ with the eyeball axial length? Braz J Anesthesiol. 2021 Nov-Dec;71(6):635-641. doi: 10.1016/j.bjane.2021.09.001. Epub 2021 Sep 22.

  PMID: 34562489 DERIVED

MeSH Terms

Interventions

Bupivacaine; Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• WALID Nofal, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Sanaa el Fawal, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Wail Abdelaal, MD

  Faculty of Medicine, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Eman Sabek, MD

  National Centre of Radiation Research and Technology, Atomic Energy Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Anesthesiology

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 29, 2019
• Study Start: July 31, 2019
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: October 22, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)