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Heavy Bupivacaine in Peribulbar Block

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Unknown
Phase 4

Conditions

Anesthetics, Local

Treatments

Drug: hyperbaric bupvacaine in Peribulbar block
Drug: isobaric bupvacaine in Peribulbar block

Study type

Interventional

Funder types

Other

Identifiers

NCT03312959
badway 2

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups

hyperbaric bupvacaine group
Experimental group
Description:
Peribulbar block will be performed using a total volume of 7 ml 6ml hyperbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline
Treatment:
Drug: hyperbaric bupvacaine in Peribulbar block
isobaric bupvacaine group
Active Comparator group
Description:
Peribulbar block will be performed using a total volume of 7 ml 6ml isorbaric bupivacaine 0.5% + hyaluronidase (50 IU) in 1ml saline
Treatment:
Drug: isobaric bupvacaine in Peribulbar block

Trial contacts and locations

1

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Central trial contact

Hassan Ali; Ahmed Badwy

Data sourced from clinicaltrials.gov

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