Clinical trial NCT04036201: Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?
Official title: Minimum Effective Volume of Local Anesthetic for Peribulbar Block.Does it Differ With the Eyeball Axial Length?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peribulbar Block
Keywords: Peribulbar block
minimum effective volume
axial eye length
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-07-29
Enrollment: 121
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: The main goal of this study is to estimate the minimum effective volume(MEV90) of local anesthetic and hyaluronic acid given for local anesthesia of the eye for 2 different axial length groups of patients undergoing eye surgery. Volume assignment was carried out using a biased coin design (BCD) up-and-down sequential method (UDM), where the volume given to each patient depends on the response of the previous one. The MEV90 was calculated using isotonic regression with bias-corrected 95% confidence interval (CI) derived by boots trapping. The mean value of the estimate was obtained from 3000 bootstrap samples.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The minimum effective volume of local anesthetic of the eye in relation to the eyeball axial length.
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine ,Ain Shams University
state: القاهرة
Study officials:
affiliation: Faculty of Medicine, Ain Shams University
name: WALID Nofal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Ain Shams University
name: Sanaa el Fawal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Medicine, Ain Shams University
name: Wail Abdelaal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Centre of Radiation Research and Technology, Atomic Energy Authority
name: Eman Sabek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.