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

NCT03713762 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: PBBCM
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Local

Keywords

Peribulbar block

Outcome Measures

Primary Outcomes (1)

• Latency period (lost of corneal reflex)

  lost of corneal reflex

  10 minutes until the start of surgery

Secondary Outcomes (3)

• Ocular akinesia: movements of extraocular muscles

  10 minutes until the start of surgery

• Incidence of postoperative pain

  2 Hours

• postoperative complications

  2 hours

Study Arms (2)

Group 1 LB

EXPERIMENTAL

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

Group 2 LBF

EXPERIMENTAL

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

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.

Also known as: lidocaine/bupivacaine

Group 1 LB

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.

Also known as: lidocaine/bupivacaine/fentanyl

Group 2 LBF

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Docente la Trinidad: lead

MeSH Terms

Interventions

Bupivacaine; Lidocaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Acetanilides

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, anesthesiologist.

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 22, 2018
• Study Start: October 1, 2009
• Primary Completion: November 30, 2009
• Study Completion: November 30, 2009
• Last Updated: October 23, 2018

Record last verified: 2018-10