Pain Management During Panretinal Photocoagulation for Diabetic Retinopathy: Safety and Efficacy of Peribulbar Anesthesia
2026年6月8日 更新者：Asociación para Evitar la Ceguera en México
Safety and Efficacy of Peribulbar Anesthesia for Pain Management in Patients With Proliferative Diabetic Retinopathy During Panretinal Photocoagulation
The purpose of this study was to compare two different anesthesia methods for pain control during panretinal photocoagulation (PRP), a type of laser surgery that treats proliferative diabetic retinopathy (PDR).
The study included eyes from patients with diabetes and proliferative diabetic retinopathy who were scheduled to undergo their first PRP session. Participants were split into two groups to receive either peribulbar anesthesia, which is a type of anesthesia injected through the eyelid, or a sham injection with topical anesthesia only.
Pain on a numerical scale and vital signs were recorded before and for 15 minutes during PRP. These results were compared between the two groups to determine which method delivers superior pain control.
調査の概要
状態
完了
条件
研究の種類
介入
入学 (実際)
50
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Mexico City
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Mexico City、Mexico City、メキシコ、04030
- Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Adults aged 18 years or older with proliferative diabetic retinopathy
- Scheduled to undergo their first PRP session
- Able to maintain the required posture at the slit lamp throughout the procedure
Exclusion Criteria:
- History of phobic anxiety disorder related to needles or injections
- Known allergies or hypersensitivity to lidocaine, bupivacaine, or tetracaine
- Use of analgesics within 24 hours prior to treatment
- Cognitive or motor impairments that could hinder effective communication of pain.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Peribulbar anesthesia intervention group
The intervention administered was topical anesthesia with peribulbar anesthesia consisting of a lidocaine and bupivacaine injection.
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A mixture of 1.5 mL of 0.5% bupivacaine and 1.5 mL of 2% lidocaine was prepared in a 3 mL syringe.
The peribulbar injection was administered using a 25G needle inserted horizontally through the inferior palpebral conjunctiva, directed axially over the infraorbital rim, and then angled upward to deliver the anesthetic into the orbit.
A single drop of topical 5% tetracaine
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偽コンパレータ：Control group
The control group received only topical anesthesia and a sham peribulbar injection.
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A single drop of topical 5% tetracaine
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain perception during PRP administration
時間枠：Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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patient perception of pain during PRP administration in each eye, measured using the Numerical Rating Scale (NRS).
The NRS measures pain intensity on a scale of 0 to 10, where 0 corresponds to the absence of pain and 10 represents the worst pain imaginable.
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Pain on the NRS scale was measured at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart rate
時間枠：at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Heart rate measured as beats per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Respiratory rate
時間枠：at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Respiratory rate measured as breaths per minute using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Oxygen saturation
時間枠：at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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Oxygen saturation was measured as SpO2 using the Aquarius Vital Sign Monitor (Shenzhen Northern Meditec Limited, Shenzhen, China)
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at baseline before the start of PRP, and at the 1-, 5-, 10-, and 15-minute marks while undergoing PRP application in each eye.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：José Gerardo García Aguirre, MD、Asociacion Para Evitar la Ceguera en Mexico, I.A.P.
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Kumar CM. Orbital regional anesthesia: complications and their prevention. Indian J Ophthalmol. 2006 Jun;54(2):77-84. doi: 10.4103/0301-4738.25826.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年7月6日
一次修了 (実際)
2024年3月21日
研究の完了 (実際)
2024年6月21日
試験登録日
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
2026年6月8日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月8日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RET-PFC01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
De-identified participant data will be made available to qualified researchers upon request to the corresponding author.
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いいえ
米国FDA規制機器製品の研究
いいえ
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