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

October 20, 2018 updated by: Leopoldo Wulff, Centro Medico Docente la Trinidad

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Article Type. Clinical trial study

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • lidocaine/bupivacaine/fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Latency period (lost of corneal reflex)
Time Frame: 10 minutes until the start of surgery
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
Time Frame: 10 minutes until the start of surgery
movements of extraocular muscles
10 minutes until the start of surgery
Incidence of postoperative pain
Time Frame: 2 Hours
Analogous visual scale
2 Hours
postoperative complications
Time Frame: 2 hours
bleeding or bruise
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Medico Docente la Trinidad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2009

Primary Completion (Actual)

November 30, 2009

Study Completion (Actual)

November 30, 2009

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 20, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBBCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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