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CompletedNCT03713762Updated Oct 23, 2018

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

A Phase 3 interventional study of peribulbar block 1 lidocaine/bupivacaine and peribulbar block 2 lidocaine/bupivacaine/fentanyl in Anesthesia, Local, sponsored by Centro Medico Docente la Trinidad. Completed. Open to participants aged 45 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-23.

Sponsored by Centro Medico Docente la Trinidad · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2009, 16 years 10 months ago, and no results have been posted to the registry.
  • Registered 9 years after the study started (first participant enrolled Oct 2009, registered Oct 2018).
Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
45 Years to 90 Years
Sex
All
01

Study 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.

Read the detailed description

Article Type. Clinical trial study

02

Conditions studied

  • Anesthesia, Local

Keywords

  • Peribulbar block
03

In context

Lead sponsor

Centro Medico Docente la Trinidad is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 90 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Group 1 LB

    Peribulbar block 1 was performed received 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml

    Drug: peribulbar block 1 lidocaine/bupivacaine

  • Experimental
    Group 2 LBF

    Peribulbar block 2 was performed received 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.

    Drug: peribulbar block 2 lidocaine/bupivacaine/fentanyl

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.

    Also known as: lidocaine/bupivacaine

  • 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.

    Also known as: lidocaine/bupivacaine/fentanyl

06

What researchers measure

Primary outcomes

  1. Latency period (lost of corneal reflex)

    lost of corneal reflex

    Time frame: 10 minutes until the start of surgery

Secondary outcomes

  1. Ocular akinesia: movements of extraocular muscles

    movements of extraocular muscles

    Time frame: 10 minutes until the start of surgery

  2. Incidence of postoperative pain

    Analogous visual scale

    Time frame: 2 Hours

  3. postoperative complications

    bleeding or bruise

    Time frame: 2 hours

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03713762
Lead sponsor
Centro Medico Docente la Trinidad
Responsible party
Leopoldo Wulff (Principal Investigator, anesthesiologist., Centro Medico Docente la Trinidad) — Principal investigator
First posted
Oct 22, 2018
Start date
Oct 1, 2009
Primary completion
Nov 30, 2009
Completion
Nov 30, 2009
Last update
Oct 23, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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