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

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ClinicalTrials.gov Identifier: NCT03713762
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Leopoldo Wulff, 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.

Condition or disease Intervention/treatment Phase
Anesthesia, Local Drug: peribulbar block 1 lidocaine/bupivacaine Drug: peribulbar block 2 lidocaine/bupivacaine/fentanyl Phase 3

Detailed Description:
Article Type. Clinical trial study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anesthesia With Peribulbar Block: Lidocaine-bupivacaine vs Lidocaine-bupivacaine-fentanyl
Actual Study Start Date : October 1, 2009
Actual Primary Completion Date : November 30, 2009
Actual Study Completion Date : November 30, 2009


Arm Intervention/treatment
Experimental: 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
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.
Other Name: lidocaine/bupivacaine

Experimental: 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.
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.
Other Name: lidocaine/bupivacaine/fentanyl




Primary Outcome Measures :
  1. Latency period (lost of corneal reflex) [ Time Frame: 10 minutes until the start of surgery ]
    lost of corneal reflex


Secondary Outcome Measures :
  1. Ocular akinesia: movements of extraocular muscles [ Time Frame: 10 minutes until the start of surgery ]
    movements of extraocular muscles

  2. Incidence of postoperative pain [ Time Frame: 2 Hours ]
    Analogous visual scale

  3. postoperative complications [ Time Frame: 2 hours ]
    bleeding or bruise



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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Responsible Party: Leopoldo Wulff, Principal Investigator, anesthesiologist., Centro Medico Docente la Trinidad
ClinicalTrials.gov Identifier: NCT03713762     History of Changes
Other Study ID Numbers: PBBCM
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Leopoldo Wulff, Centro Medico Docente la Trinidad:
Peribulbar block

Additional relevant MeSH terms:
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Bupivacaine
Lidocaine
Anesthetics
Fentanyl
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General