Comparison of Postoperative Pain With Two Different Types of Local Anesthesia in Surgery for a Drooping Eyelid
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| ClinicalTrials.gov Identifier: NCT01350024 |
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Recruitment Status :
Completed
First Posted : May 9, 2011
Last Update Posted : May 30, 2017
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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 or disease | Intervention/treatment | Phase |
|---|---|---|
| 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 | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 34 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Actual Study Start Date : | May 1, 2011 |
| Actual Primary Completion Date : | July 30, 2016 |
| Actual Study Completion Date : | July 30, 2016 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Frontal Nerve Block
Patients will receive a frontal nerve block for anesthesia
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Procedure: Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine
Frontal Nerve Block 5 cc will be administered preoperatively once. |
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Active Comparator: Subconjucntival Injection
Patients will receive a subconjunctival injection for anesthesia
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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 |
- 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.
- 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.
- Pain Control [ Time Frame: 1 hour after surgery ]completion of survey to assess pain after surgery has been completed.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350024
| United States, Florida | |
| Bascom Palmer Eye Institute | |
| Miami, Florida, United States, 33136 | |
| Responsible Party: | Dr. Wendy Lee, Assoc. Professor of Clinical, University of Miami |
| ClinicalTrials.gov Identifier: | NCT01350024 History of Changes |
| Other Study ID Numbers: |
20100631 |
| First Posted: | May 9, 2011 Key Record Dates |
| Last Update Posted: | May 30, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Dr. Wendy Lee, University of Miami:
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Conjunctival Mullerectomy Blepharoptosis Ptosis surgery Pain Control |
Additional relevant MeSH terms:
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Pain, Postoperative Blepharoptosis 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 |