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OpenTrials
Completed

NCT Number: NCT01350024

Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid

Conjunctival Mullerectomy is a well known procedure used to correct upper lid ptosis via a posterior approach. Patients who undergo this procedure are often given local anesthesia to alleviate intraoperative and postoperative pain. Local anesthesia can be given via frontal nerve block or subconjunctival injection combined with sedation in most cases. Both techniques are currently acceptable options for local anesthesia, however postoperative pain has not been systematically evaluated between these two techniques.

The investigators aim to compare intra-operative and postoperative pain with these two techniques in patients undergoing conjunctival Mullerectomy for ptosis repair. Patients will be randomized to receive local anesthesia via frontal nerve block or via subconjunctival injection. In addition, the investigators will measure the surgical outcomes of the ptosis surgery with standard measures.

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Key information

Conditions

Blepharoptosis Agnosia Eye Diseases Eyelid Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and older
  • Patient with ptosis that requires correction
  • Patient is able to consent for themselves

Exclusion criteria

  • Patient unable to complete survey
  • Patient had prior lid surgery
  • Patient taking chronic pain medication

Treatment and study plan

Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine

Procedure

Frontal Nerve Block 5 cc will be administered preoperatively once.

Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine

Procedure

Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above

Primary outcomes

  1. Pain control

    Time frame: 24 hour after surgery

    Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.

Secondary outcomes

  1. Efficacy of ptosis surgery

    Time frame: 2 months

    Standard measures include marginal reflex distanced, palpebral fissure and levator fucntion will be used to assess the efficacy of the ptosis surgery and compared to the type of anesthesia the patient was given.

  2. Pain Control

    Time frame: 1 hour after surgery

    completion of survey to assess pain after surgery has been completed.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
May 9, 2011
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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