Heavy Bupivacaine in Peribulbar Block

Heavy Bupivacaine Versus Plain Bupivacaine in Peribulbar Block

Most of the ophthalmic procedures are performed under local anesthesia as the patient is often elderly and with diseases. This may increase the risk of morbidity and mortality under general anesthesia. Different eye blocks have been practiced with great success. Moreover, it is associated with less hemodynamic instability, less respiratory depression, better postoperative pain relief, and less nausea and vomiting than general anesthesia. It is also associated with a reduction in stress response, maintained oxygen saturation and cardiovascular stability, in addition to the production of good akinesia and anesthesia alleviating occulo-medullary reflexes, all make local anesthesia more superior and safe technique.

Study Overview

• Status: Unknown
• Conditions: Anesthetics, Local
• Intervention / Treatment: Drug: hyperbaric bupvacaine in Peribulbar block; Drug: isobaric bupvacaine in Peribulbar block

Detailed Description

Peribulbar anesthesia is widely practiced now as a safe local block for cataract eye surgeries. However, the limited duration of these blocks was shown to be the main problem encountered intra-operatively. Therefore, additional top-up doses are usually needed to continue the operation. Many kinds of research tried to introduce solutions in order to prolong the duration of the local anesthetics used. Many researchers tried different volumes, doses and adjuvant to local anesthetics, and studied their effects There are many studies that evaluated the effect of baricity of local anesthetic on the potency of motor block and the duration of motor and sensory blockade.

However, no properly designed randomized, controlled studies have evaluated the feasibility and reliability of baricity local anesthetic agents used for the peribulbar block.

Aim of the work prospective, randomized study was conducted to evaluate the effects of the baricitized bupivacaine used for the peribulbar block in patients undergoing posterior segment surgeries.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Giza
    • Cairo, Giza, Egypt, 1234
      • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with American Society of Anesthesiology (ASA) I or II.
• 30-80 years old
• Patients scheduled for elective unilateral posterior segment surgeries.

Exclusion Criteria:

• Patient's refusal.
• orbital deformity
• axial length( >28 mm )
• increased intraocular pressure, or if they were blind in the contralateral eye, international normalized ratio (INR) > 1.5
• allergy to local anesthetics, mentally retarded patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hyperbaric bupvacaine group; Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline	Drug: hyperbaric bupvacaine in Peribulbar block; hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery; Other Names: trial group
Active Comparator: isobaric bupvacaine group; Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline	Drug: isobaric bupvacaine in Peribulbar block; isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery; Other Names: control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The onset and duration of lid and globe akinesia	scoring the ocular movements in each direction of gaze	12 hours postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): January 20, 2018
• Study Completion (Anticipated): January 31, 2018

Study Registration Dates

• First Submitted: October 13, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 13, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: badway 2

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