Ultrasound-Guided Intermediate Cervical Plexus Block for Postoperative Analgesia in Vagus Nerve Stimulation Surgery
Effects of Ultrasound-Guided Intermediate Cervical Plexus Block on Postoperative Analgesia and Opioid Consumption in Vagus Nerve Stimulation Surgery: A Prospective Randomized Controlled Trial
調査の概要
状態
詳細な説明
Postoperative pain following vagus nerve stimulation (VNS) implantation surgery originates from both cervical and infraclavicular surgical incisions. Although opioid analgesics are commonly used for postoperative pain control, minimizing opioid exposure is particularly desirable in patients with drug-resistant epilepsy because opioid-related adverse effects may delay recovery and potentially influence neurological assessment.
The intermediate cervical plexus block (ICB) is an ultrasound-guided regional anesthesia technique that provides sensory blockade of the superficial branches of the cervical plexus while allowing accurate deposition of local anesthetic between the investing and prevertebral layers of the deep cervical fascia. Previous studies have demonstrated the effectiveness of cervical plexus blocks in various cervical surgical procedures; however, evidence regarding their use during VNS implantation surgery remains limited.
This prospective, randomized, double-blind, placebo-controlled study compares ultrasound-guided ICB using 10 mL of 0.25% bupivacaine with a placebo injection of 10 mL normal saline administered after induction of general anesthesia. The primary objective is to determine whether ICB reduces postoperative opioid requirements during the first 24 hours after surgery. Secondary objectives include evaluation of intraoperative remifentanil consumption, postoperative pain scores, time to first rescue analgesic, length of hospital stay, and postoperative seizure incidence. The findings are expected to provide evidence regarding the effectiveness and safety of ultrasound-guided intermediate cervical plexus block as part of multimodal analgesia for patients undergoing VNS implantation surgery.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Elâzığ
-
Elâzığ、Elâzığ、トルコ（Türkiye）、23100
- Fırat University Faculty of Medicine Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Adults aged 18-60 years
- American Society of Anesthesiologists (ASA) physical status II-III
- Drug-resistant epilepsy
- Scheduled for elective vagus nerve stimulation implantation surgery under general anesthesia
- Written informed consent obtained
Exclusion Criteria:
- Allergy or contraindication to local anesthetics
- Coagulopathy or current anticoagulant therapy
- Infection at the injection site
- Pregnancy or breastfeeding
- Severe pulmonary disease
- Inability to understand or use the Numeric Rating Scale (NRS)
- Refusal to participate
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：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 |
|---|---|
|
実験的：Intermediate Cervical Plexus Block
Participants received an ultrasound-guided intermediate cervical plexus block with 10 mL of 0.25% bupivacaine after induction of general anesthesia before vagus nerve stimulation implantation surgery.
|
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.25% bupivacaine administered during ultrasound-guided intermediate cervical plexus block.
|
|
プラセボコンパレーター：Control
Participants received an ultrasound-guided placebo injection with 10 mL of 0.9% normal saline after induction of general anesthesia before vagus nerve stimulation implantation surgery.
|
Ultrasound-guided intermediate cervical plexus block performed after induction of general anesthesia.
10 mL of 0.9% sodium chloride administered as a placebo injection under ultrasound guidance.
|
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 |
|---|---|---|
|
Total postoperative morphine consumption during the first 24 hours after surgery
時間枠：24 hours after surgery
|
Total cumulative intravenous morphine consumption during the first 24 hours after vagus nerve stimulation implantation surgery, recorded in milligrams (mg).
|
24 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intraoperative remifentanil consumption
時間枠：From induction of anesthesia until the end of surgery
|
Total intraoperative remifentanil consumption recorded in micrograms (µg) from induction of anesthesia until completion of surgery.
|
From induction of anesthesia until the end of surgery
|
|
Postoperative pain intensity
時間枠：From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
|
Pain intensity was assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at PACU admission, 30 minutes after PACU admission, and at postoperative 1, 6, 12, and 24 hours.
|
From admission to the post-anesthesia care unit (PACU) through 24 hours postoperatively
|
|
Time to first rescue analgesic request
時間枠：Within 24 hours after surgery
|
Time from arrival in the post-anesthesia care unit (PACU) until the first administration of rescue analgesia, measured in minutes.
|
Within 24 hours after surgery
|
|
Length of hospital stay
時間枠：From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
|
Time to first rescue analgesic request was defined as the time from PACU arrival to the first request or administration of rescue analgesia.
Patients who did not require rescue analgesia within 24 hours were censored at 24 hours.
|
From arrival in the post-anesthesia care unit (PACU) until the first rescue analgesic request, assessed up to 24 hours postoperatively
|
|
Postoperative seizure incidence
時間枠：Within 24 hours after surgery
|
Occurrence of clinically observed postoperative seizure episodes during the first 24 postoperative hours.
|
Within 24 hours after surgery
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Ahmet Aksu, Assistant Professor、Fırat University Faculty of Medicine Department of Anaesthesiology and Reanimation
研究記録日
主要日程の研究
研究開始 (実際)
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 (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
- 7996
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?
IPD プランの説明
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
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。