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

NCT ID: NCT03713762

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-01
• Study Completion Date: 2009-11-30

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

Conditions

Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: EXPERIMENTAL

peribulbar block 1 lidocaine/bupivacaine

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

peribulbar block 2 lidocaine/bupivacaine/fentanyl

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

lidocaine/bupivacaine; lidocaine/bupivacaine/fentanyl

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centro Medico Docente la Trinidad

OTHER

Sponsor Role: lead

Responsible Party

Leopoldo Wulff

Principal Investigator, anesthesiologist.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PBBCM

Identifier Type: -

Identifier Source: org_study_id