Does Perineural Dexamethasone Prolong Duration of a Nerve Block?
Does Perineural Dexamethasone Prolong Duration of an Adductor Canal Block When Controlling for a Systemic Effect? A Paired, Randomized, Blinded, Study in Healthy Volunteers
The purpose of this study is to investigate whether dexamethasone as an adjuvant to ropivacaine for adductor canal block increases duration of the sensory block, when controlling for a systemic effect using a paired design and bilateral blocks.
The investigators hypothesize that adding dexamethasone to ropivacaine will prolong block duration compared with ropivacaine + placebo.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
Hellerup
-
Gentofte、Hellerup、デンマーク、2900
- Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
-
-
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:
- American Society of Anesthesiologists class 1
- Body Mass Index 18-30
Exclusion Criteria:
- Allergy to study medication
- Earlier trauma or surgery to lower limb
- Diabetes Mellitus
- Alcohol or drug abuse
- Daily intake of opioids or steroids last 4 weeks
- Daily intake of any analgesics last 48 hours
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：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Ropivacaine + dexamethasone
20 ml ropivacaine 0.5% + 0.5 ml dexamethasone 4 mg7ml
|
Adductor canal block, single bolus
|
|
プラセボコンパレーター：Ropivacaine + placebo
20 ml ropivacaine 0.5% + 0.5 ml isotonic saline ad
|
Adductor canal block, single bolus
|
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 |
|---|---|---|
|
Difference in duration of sensory block between dexamethasone and placebo assessed as cold sensation with an alcohol swab
時間枠：0-36 hours
|
Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0, except at 2 and 3 hours post block where there will be a break and no assessments will be performed.
|
0-36 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed by pin-prick
時間枠：0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed).
|
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test
時間枠：0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed). Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value. |
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as warmth detection threshold
時間枠：0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. |
0-36 hours
|
|
Difference between dexamethasone and placebo in the duration of a sensory block assessed as heat pain detection threshold
時間枠：0-36 hours
|
Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block (except at 2 and 3 hours post block where there will be a break and no assessments will be performed and only assessed if pain scores during tonic heat stimulation is above 0 ). Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value. |
0-36 hours
|
|
Difference in maximum pain scores between dexamethasone and placebo during block and after recovery of normal sensation
時間枠：0-36 hours
|
Pain scores during a tonic heat stimulation will be compared at 4 h post block and 1 h after pain scores have returned to the pre-block values.
|
0-36 hours
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Pia Jæger, MD, PhD、Rigshospitalet, Denmark
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
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