Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl

Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03713762

Enrollment

Registered

2018-10-22

Start date

2009-10-01

Completion date

2009-11-30

Last updated

2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local

Keywords

Peribulbar block

Brief summary

Ophthalmological procedures such as cataract extraction can be carried out with a peribulbar block (PBB). The advantages of this anesthetic technique include a lower incidence of coughing, unwanted movements and emesis during awakening, in addition to providing adequate postoperative analgesia. The researchers want to investigate whether the use of fentanyl citrate by peribulbar route, when administered with a local anesthetic, shortens the anesthetic latency, interfere with the degree of akinesia and if provides greater postoperative analgesia.

Detailed description

Article Type. Clinical trial study

Interventions

DRUGperibulbar block 1 lidocaine/bupivacaine

Peribulbar block: 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml.

DRUGperibulbar block 2 lidocaine/bupivacaine/fentanyl

Peribulbar block: 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to 90 Years

Healthy volunteers

Yes

Inclusion criteria

* All patients scheduled for cataract surgery (Cataract Extracapsular Extraction) * With indication of regional anesthesia with peribulbar block * Physical status ASA I or II * Patients between 45 and 90 years of age

Exclusion criteria

* Allergic to amide-type anesthetics and fentanyl citrate * Patients with a history of woody thorax * Patients with uncompensated systemic diseases * Patients in whom it was necessary to change the anesthetic technique due to insufficient analgesia or those in which the administration of intravenous analgesics was required during the operative period.

Design outcomes

Primary

Measure	Time frame	Description
Latency period (lost of corneal reflex)	10 minutes until the start of surgery	lost of corneal reflex

Secondary

Measure	Time frame	Description
Ocular akinesia: movements of extraocular muscles	10 minutes until the start of surgery	movements of extraocular muscles
Incidence of postoperative pain	2 Hours	Analogous visual scale
postoperative complications	2 hours	bleeding or bruise

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026