Intrathecal Analgesia in Laparoscopic Nissen Fundoplication.
Intrathecal Morhine or Fentanyl Compared to Intravenous Morphine in Laparoscopic Nissen Fundoplication.
Patients planned for laparoscopic Nissen fundoplication or robotic- assisted laparoscopic surgery will receive either intrathecal morphine, intrathecal fentanyl or iv morphine (control).
Perioperative total opioid consumption, Postoperative Pain Numeric Rating scale, grade of nausea and time in the postoperative ward are compared. Total grade of patient satisfaction (0-10) as well as total hospital length are also compared.
調査の概要
状態
詳細な説明
Study Description:
Background:
The field of laparoscopic and robotic-assisted laparoscopic surgery increases all the time. Older and more fragile patients can be suitable for laparoscopic surgery compared to open surgery, because of the less trauma and inflammatory response to the surgery and thereby faster recovery.
Extreme positioning of the patients as well as painful stimuli during and after surgery could still stress the circulatory response of the patient causing a mismatch in oxygen delivery and needs. Perioperative pain relief could be even more important during this type of surgery, when painful stimuli are more unpredictable.
This Study:
In this study painful stimuli during surgery are registered by the NOL pain monitor (Nociception Level) and intraoperative dosing of analgesia (remifentanil) is guided by the NOL index. NOL < 25 is accepted during surgery.
All patients receive preoperative: Acetaminophen 1g, Meclozinehydrocloride 25mg.
• Total opioid consumption during and after surgery is compared between three groups of patients receiving: Patients receiving Fentanyl intrathecal need 6 hours postoperative observation and patients receiving morphine intrathecal need 10 hours observation time.
- Preoperative: Oxycodone orally
- Preoperative: Intrathecal Fentanyl
- Preoperative Intrathecal Morphine. Preoperative pain assessment of the patients are Postoperative Pain from Assessment of Pain Associated with Venous Cannulation (1-10)
Anesthesia: Induction of anesthesia with propofol, remifentanil and rocuronium. During surgery: Sevoflurane + remifentanil. BIS 35-50. NOL <25. Monitoring: EKG, Blood pressure, BIS (Bispectral index) and NOL. Before wake up: Parecoxib 40mg iv. Ondansetron 4mg iv. Group 1: Morphine 0,05mg/kg iv. 10 min before waking up: 1ug/kg fentanyl to all patients. Time of surgery is also registered and volume of bleeding as well.
After surgery:
NRS (Numeric Pain Scores (0-10) are registered in the PAVU when the patient is at the PACU, when leaving the PACU as well as the maximum pain score postoperative.
Total dose of opioids converted to morphine equivalents are compared between the groups as well as the pain scores and time in the PACU.
Power calculation show a need for 63 patients to receive 80% power to show a difference in morphine-equivalents between groups of 1 mgs. (p<0,05).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Värmland County
-
Karlstad、Värmland County、スウェーデン、65229
- Department of Anesthesia & Intensive Care, Central Hospital of Karlstad
-
-
参加基準
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
説明
Inclusion Criteria: All patients scheduled for laparoscopic fundoplicatio surgery
-
Exclusion Criteria: -
- Age < 18 years
- Chronic pain problems or abuse.
- Pregnancy
- Exclusion ciriteria for spinal anesthesia.
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：支持療法
- 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 |
|---|---|
|
アクティブコンパレータ：Intrathecal Fentanyl 20ug
Preoperative spinal with 20ug Fentanyl
|
Intrathecal Fentanyl
|
|
アクティブコンパレータ：Intrathecal Morphine 100ug
Preoperative Spinal with 100ug Morhine.
|
Norhine 100ug intrathecal
他の名前：
|
|
他の：Intravenous Morphine analgesia
NOL- guided Intravenous Morphine analgesia
|
NOL guided intravenous morphine analgesia
他の名前：
|
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 |
|---|---|---|
|
Three different treatments of pain during during laparoscopic and/or robotic assisted laparoscopic Nissen fundoplication.
時間枠：From enrollment to the end of treatment - usually the day after surgery.
|
|
From enrollment to the end of treatment - usually the day after surgery.
|
|
Postoperative pain assessed using the Visual Analogue Scale (VAS) upon arrival to the post-anesthesia care unit (PACU), maximum VAS score in PACU, and at discharge to ward/home/patient hotel.
時間枠：From inclusion to the day after surgery.
|
Secondary outcomes:
8. Need for urinary catheterization (indwelling catheter or intermittent catheterization) within 24 hours postoperatively or at discharge. |
From inclusion to the day after surgery.
|
|
"Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0"
時間枠："From enrollment to the end of treatment at the day after surgery
|
Paricipants arriving at the PACU with pain score according to the Visual Analogue Scale (VAS) > 3
|
"From enrollment to the end of treatment at the day after surgery
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
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
- 2025-04374-01
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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