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

Anesthesia, Local Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03713762
• Other study ID #: PBBCM
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2009
• Est. completion date: November 30, 2009

Study information

• Verified date: October 2018
• Source: Centro Medico Docente la Trinidad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Article Type. Clinical trial study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 30, 2009
• Est. primary completion date: November 30, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local

Intervention

Drug:
• peribulbar 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.
• peribulbar 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Medico Docente la Trinidad

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Latency period (lost of corneal reflex)	lost of corneal reflex	10 minutes until the start of surgery
Secondary	Ocular akinesia: movements of extraocular muscles	movements of extraocular muscles	10 minutes until the start of surgery
Secondary	Incidence of postoperative pain	Analogous visual scale	2 Hours
Secondary	postoperative complications	bleeding or bruise	2 hours