Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Bascom Palmer Eye Institute.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Bascom Palmer Eye Institute
Information provided by:
Bascom Palmer Eye Institute
ClinicalTrials.gov Identifier:
NCT01350024
First received: May 5, 2011
Last updated: May 6, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Blepharoptosis |
Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid |
Resource links provided by NLM:
Drug Information available for:
Epinephrine bitartrate
Epinephrine
Epinephrine hydrochloride
Lidocaine hydrochloride
Lidocaine
Racepinephrine hydrochloride
Racepinephrine
U.S. FDA Resources
Further study details as provided by Bascom Palmer Eye Institute:
Primary Outcome Measures:
- Pain control [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]Patients will be asked to complete a survey regardning pain assessment twenty-four hours after completion of surgery.
Secondary Outcome Measures:
- Efficacy of ptosis surgery [ Time Frame: 2 months ] [ Designated as safety issue: No ]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.
- Pain Control [ Time Frame: 1 hour after surgery ] [ Designated as safety issue: No ]completion of survey to assess pain after surgery has been completed.
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | November 2011 |
| Estimated Primary Completion Date: | November 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Frontal Nerve Block
Patients will receive a frontal nerve block for anesthesia
|
Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Frontal Nerve Block 5 cc will be administered preoperatively once.
|
|
Active Comparator: Subconjucntival Injection
Patients will receive a subconjunctival injection for anesthesia
|
Procedure: Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine
Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01350024
Please refer to this study by its ClinicalTrials.gov identifier: NCT01350024
Contacts
| Contact: Chad C Zatezalo, MD | 305-326-6000 ext 6788 | czatezalo@med.miami.edu | |
| Contact: Wendy Lee, MD | 305-325-6000 ext 6788 | wlee@med.miami.edu |
Locations
| United States, Florida | |
| Bascom Palmer Eye Institute | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Chad C Zatezalo, MD 305-326-6000 ext 6788 czatezalo@med.miami.edu | |
| Contact: Wendy Lee, MD 305-326-6000 ext 6788 wlee@med.miami.edu | |
| Principal Investigator: Wendy Lee, MD | |
| Sub-Investigator: Chad C Zatezalo, MD | |
Sponsors and Collaborators
Bascom Palmer Eye Institute
More Information
| Responsible Party: | Wendy Lee, MD, Bascom Palmer Eye Institute, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01350024 History of Changes |
| Other Study ID Numbers: | 20100631 |
| Study First Received: | May 5, 2011 |
| Last Updated: | May 6, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Bascom Palmer Eye Institute:
|
Conjunctival Mullerectomy Blepharoptosis Ptosis surgery Pain Control |
Additional relevant MeSH terms:
|
Blepharoptosis Pain, Postoperative Pain Neurologic Manifestations Nervous System Diseases Postoperative Complications Pathologic Processes Signs and Symptoms Eyelid Diseases Eye Diseases Anesthetics Lidocaine Epinephrine Racepinephrine Epinephryl borate |
Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Local 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 Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Adrenergic beta-Agonists |
ClinicalTrials.gov processed this record on September 28, 2016