Intravenous Lidocaine to Prevent Post-Fundal Pressure Headache During Cesarean Section (LID-HEAD)
Pre-emptive Single Intravenous Lidocaine Dose to Prevent Post-Fundal Pressure Headache During Cesarean Section: The LID-HEAD Multi-center Randomized Controlled Trial
調査の概要
詳細な説明
This fundal pressure was previously evaluated for its effect on maternal hemodynamics during cesarean section. The investigators observed in their practice that a complaint of headache is reported by a percentage of patients immediately after fundal pressure and fetal delivery. Despite its small percentage, it had a negative impact on the maternal experience.
The proposed mechanism of this headache may be attributed to the fundal pressure-induced cushing reflex, vasopressin response, or cerebral venous engorgement all resulted from the increase in intra-abdominal pressure which can be reflected on the intra-thoracic pressure and the intracranial pressure (ICP).
Lidocaine is a local anesthetic that, when given via intravenous (IV) route could attenuate the rise in ICP during tracheal suctioning, and decrease the optic nerve sheath diameter distension during endotracheal intubation and during laparoscopy. These effects could be established by reducing cerebral blood volume through its vasoconstrictive effects on the cerebral vasculature and by decreasing electrical activity and metabolic demands through its inhibitory effects on sodium channels.
The fundal pressure maneuver is supposed to produce pathophysiological changes that resemble the previously reported factors that led to ICP elevation (intubation and pneumo-peritoneum). So, this study will be conducted as the investigators hypothesize that the administration of single IV lidocaine dose shortly before uterine fundal pressure may attenuate the temporary rise in ICP which may decrease the incidence of headache.
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Osama M Rehab, MD
- 電話番号：+201095210806
- メール：osamarehab@med.tanta.edu.eg
研究場所
-
-
Gharbia Governorate
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Tanta、Gharbia Governorate、エジプト、31527
- 募集
- Tanta University Hospitals
-
コンタクト：
- Osama M Rehab, MD
- 電話番号：+201095210806
- メール：osamarehab@med.tanta.edu.eg
-
-
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:
- Aged ≥ 18 years
- American Society of Anesthesiologists (ASA) Physical Status II
- Scheduled for elective cesarean section under spinal anesthesia
Exclusion Criteria:
- Patients declined to participate in the trial,
- Patients with history of any type of headache, mental illness, or cerebrovascular diseases
- Previous epidural insertion for painless labor or any other indications;
- Patients on opioid or analgesic medications;
- Those with pregnancy-induced hypertension or diabetic patients,
- Allergy to lidocaine;
- Contraindication or failure of 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：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：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Lidocaine group
IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision
|
IV lidocaine 1.5 mg/kg (diluted with 0.9% isotonic saline to a total volume of 10 ml) over 5 minutes with the start of skin incision after ensuring negative baseline headache.
|
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プラセボコンパレーター：Control group
IV 10 ml isotonic saline over the same period
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IV 10 ml isotonic saline over 5 minutes with the start of skin incision after ensuring negative baseline headache.
|
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 |
|---|---|---|
|
Incidence of intraoperative headache
時間枠：Up to the end of surgery.
|
The incidence of intraoperative headache that may occur after fundal pressure application until the end of surgery will be recorded.
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Up to the end of surgery.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Severity of intraoperative headache
時間枠：Up to the end of surgery.
|
The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of headache.
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Up to the end of surgery.
|
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The changes in optic nerve sheath diameter
時間枠：Up to the end of surgery.
|
Optic nerve sheath diameter will be assessed by ultrasound before spinal block, at skin incision, after fetal delivery, and at the end of surgery.
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Up to the end of surgery.
|
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Incidence of shoulder pain
時間枠：Up to 24 hours after surgery.
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The incidence of shoulder pain that may occur intraoperatively and up to 24 hours after surgery will be recorded by asking the patients if they have any pain in their shoulder area.
The numerical rating scale (NRS) scores which is a 11-point scale ranging from 0= no pain to 10= most severe pain will be used to evaluate the severity of shoulder pain.
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Up to 24 hours after surgery.
|
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Neonatal Apgar (appearance, pulse, grimace, activity, and respiration) scores
時間枠：Up to 5 minutes after delivery.
|
Neonatal Apgar scores which include five signs (appearance, pulse, grimace, activity, and respiration) will be recorded at 1 min and 5 minutes after delivery.
Each sign has a score of 0, 1, 2 with a total score of 10.
Scores more than 6 indicate normal good health.
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Up to 5 minutes after delivery.
|
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side effects
時間枠：Intraoperative up to 1 hour after surgery.
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Nausea and vomiting, hypotension and bradycardia will be recorded
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Intraoperative up to 1 hour after surgery.
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Incidence of postoperative headache
時間枠：Up to 24 hours after surgery.
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The incidence of any headache that may occur from the end of surgery up to 24 hours after surgery will be recorded.
|
Up to 24 hours after surgery.
|
協力者と研究者
スポンサー
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
その他の研究ID番号
- 36265PR75/5/26
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IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
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- SAP
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