Use of Recombinant Hyaluronidase Human is Effective for the Use of Local Blocks for Eyelid's Surgery

December 18, 2014 updated by: Duke University

The Application of Recombinant Human Hyaluronidase is Effective for the Use of Local Blocks for Eyelid Surgery

To evaluate the use of recombinant hyaluronidase (rHuPH20) as an adjunctive for local anaesthesia, lidocaine 2% with epinephrine 1:100000, for eyelid surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Subjects scheduled for bilateral upper eyelid surgery will be recruited from among the patients of the Duke Eye Center. After consent is obtained following full explanation of the research, subjects will be randomly assigned (1:1 ratio) on the day of the surgery to receive local anaesthesia by either with recombinant hyaluronidase (rHuPH20) or without it. Approximately 2 ml of prepared block will be infiltrated in both upper eyelids.

Dilutions (Blocks):

A) 0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml B) 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20

Test preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon.

A Pinprick pain test will be perform 5 minutes after each injection using a sterile "finger stick" needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe). An average pain score will be calculated for each eyelid. This will help determine if one of the 2 dilutions have a faster anaesthetic effect.

Patients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Eye Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • Inclusion Criteria:
  • Capable and willing to provide consent
  • Has been scheduled for bilateral upper eyelid surgery
  • At least 18 years of age
  • Exclusion Criteria:
  • Unable or unwilling to give consent
  • Previous upper eyelid surgery
  • Under 18 years of age

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyaluronidase

Dilutions (Blocks):

0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml
Drug: Hyaluronidase
Other Names:
  • Dilutions (Blocks):
  • 0.5 mL of lidocaine 2% with epinephrine 1:100,000 and 0.5 mL of marcaine 0.75% and 1 mL (150 U) of rHuPH20 for a total of 75 U/ml
Other: Comparitor
2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20
Other: 2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain sensation
Time Frame: 5 minutes after injection

Test preparation will be applied subcutaneously in both upper eyelids by injection using a 30-gauge injection needle with the patient in supine position. Every patient will be injected by the same Oculoplastic surgeon.

A second investigator (masked to the treatment condition of each eye) will test Pinprick pain Sensation 5 minutes after each injection using a sterile "finger stick" needle at three sites of each upper eyelid. These sites include medial, central and lateral portion of each eyelid, approximately 4 mm above the lid margin. The subject will be asked to rate the degree of pain experienced at each site on a scale from 0 (none) to 10 (severe).
5 minutes after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anesthesia duration
Time Frame: After procedure started
Patients will also be instructed to inform the surgeon of precisely when the pain began and subsided to accurately record the duration of the pain experienced.
After procedure started

Collaborators and Investigators

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

Sponsor

Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

February 10, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (Estimate)

February 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 19, 2014

Last Update Submitted That Met QC Criteria

December 18, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00051289

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.

Clinical Trials on Upper Eyelid Surgery

Clinical Trials on Hyaluronidase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe