Fentanyl as an Adjuvant to Peribulbar Block in Buckle or Squint Surgeries
The Effect of Using Fentanyl as an Adjuvant to Peribulbar Block to Decrease the Introaoperative Muscle Traction Pain (Proprioception) in Squint and Buckle Surgeries in Adults: RCT
The use of fentanyl as an adjuvant to local anesthetic mixture in many regional blocks. It was effective when used in peribulbar block in cataract and vitreoretinal surgeries.
Our study will assess its efficacy in abolishing pain during muscle traction which is usually a complain for many patients a reason to use systemic opioid intra operatively or even general anesthesia
調査の概要
詳細な説明
After the patient enters the OR room, an intravenous cannula will be introduced, pulse oximeter, ECG and NIBP monitors will be connected.
Nasal oxygen cannula connected; 10 ml of local anesthetic mixture is injected depending on the group the patient is allocated.
Increments of intravenous intravenous fentanyl and midazolam will be given if patient experienced unbearable pain.
All patient received peribulbar block by an experienced anesthesiologist, both patient and anesthesiologist were blinded to the drug mixture used.
Each patient received 10 ml of the anesthetic mixture according to his/ her group.
The patient was asked to fix his eyes looking straight forward toward the ceiling while lying in a supine position. A 10 ml syringe with a 25G needle was used for the local anesthetic injection. After negative aspiration, the first 5 ml were slowly injected at the junction of the lateral one third and medial two thirds of the inferior orbital margin with the bevel directed towards the equator of the eye ball parallel to the orbital floor and the other 5 ml were given between the caruncle and the medial canthus. Intermittent gentle massage was applied for 10 minutes. After satisfactory sensory and motor block, oxygen 3 L/min was delivered through a nasal cannula to the patient. Surgery was then allowed to proceed.
研究の種類
入学 (予想される)
段階
- 初期フェーズ 1
連絡先と場所
研究連絡先
- 名前：abeer S Salem, MD
- 電話番号：002 01125666006
- メール：abeersamirali@gmail.com
研究場所
-
-
-
Giza、エジプト
- 募集
- Research Institute of Ophthalmology
-
コンタクト：
- Abeer Samir Salem, MD
- 電話番号：00201125666006
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- ASA 1, 2 & 3
- Age 18 to 70
- Patients undergoing squint or buckle surgeries
Exclusion Criteria:
- Sensitivity to any drug used in this study
- Refusal of the patient for peribulbar block
- Redo squint surgeries or previous buckle insertion
- High axial length if documented
- mentally retarded patients and
- failure of proper communication as in deafness,
- coagulation abnormalities (INR>1.4),
- infection at the injection site
研究計画
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：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：group f
patient received 50 mic fentanyl as an adjuvant to the local anesthetic mixture applied during peribulbar block in the operative eye
|
50 mic fentanyl added as an adjuvant
|
|
プラセボコンパレーター：group C
received the traditional mixture used
|
50 mic fentanyl added as an adjuvant
|
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 |
|---|---|---|
|
pain during muscle traction
時間枠：Intraoperative period
|
numeric rating Scale for pain a scale from 0 to 10 where 0 is no pain and 10 is unbearable pain
|
Intraoperative period
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
surgeon satisfaction
時間枠：intraoperative
|
yes or no
|
intraoperative
|
協力者と研究者
捜査官
- 主任研究者：Abeer S Salem, MD、Research Institute of Ophthalmology
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。