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

Phase 3

Completed

• Conditions: Anesthesia, Local
• Interventions: Drug: peribulbar block 1 lidocaine/bupivacaine; Drug: peribulbar block 2 lidocaine/bupivacaine/fentanyl

• Registration Number: NCT03713762
• Lead Sponsor: Centro Medico Docente la Trinidad

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

Study Timeline

• Study Start: 2009-10-01
• Primary Completion: 2009-11-30
• Study Completion: 2009-11-30
• Status Verified: 2018-10
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-19
• Last Update Submitted: 2018-10-20
• Study First Posted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 LB	peribulbar block 1 lidocaine/bupivacaine	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 2 LBF	peribulbar block 2 lidocaine/bupivacaine/fentanyl	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.

Primary Outcome Measures

Name	Time	Method
Latency period (lost of corneal reflex)	10 minutes until the start of surgery	lost of corneal reflex

Secondary Outcome Measures

Name	Time	Method
Ocular akinesia: movements of extraocular muscles	10 minutes until the start of surgery	movements of extraocular muscles
Incidence of postoperative pain	2 Hours	Analogous visual scale
postoperative complications	2 hours	bleeding or bruise