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

Study Overview
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Brief Summary
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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
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Article Type. Clinical trial study

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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: peribulbar block 1 lidocaine/bupivacaine
* Drug: peribulbar block 2 lidocaine/bupivacaine/fentanyl


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 LB<br>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<br>* 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.<br>* Other names: lidocaine/bupivacaine;|
| Experimental: Group 2 LBF<br>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<br>* 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.<br>* Other names: lidocaine/bupivacaine/fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency period (lost of corneal reflex) | lost of corneal reflex | 10 minutes until the start of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular akinesia: movements of extraocular muscles | movements of extraocular muscles | 10 minutes until the start of surgery | 
| Incidence of postoperative pain | Analogous visual scale | 2 Hours | 
| postoperative complications | bleeding or bruise | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peribulbar block