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Completed

NCT Number: NCT03713762

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

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.

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Key information

Conditions

Anesthesia, Local

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Article Type. Clinical trial study

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

peribulbar block 1 lidocaine/bupivacaine

Drug

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.

Other names: lidocaine/bupivacaine

peribulbar block 2 lidocaine/bupivacaine/fentanyl

Drug

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.

Other names: lidocaine/bupivacaine/fentanyl

Primary outcomes

  1. Latency period (lost of corneal reflex)

    Time frame: 10 minutes until the start of surgery

    lost of corneal reflex

Secondary outcomes

  1. Ocular akinesia: movements of extraocular muscles

    Time frame: 10 minutes until the start of surgery

    movements of extraocular muscles

  2. Incidence of postoperative pain

    Time frame: 2 Hours

    Analogous visual scale

  3. postoperative complications

    Time frame: 2 hours

    bleeding or bruise

Sponsors and collaborators

Lead sponsor

Centro Medico Docente la Trinidad

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 22, 2018
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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