Lumbar Paravertebral in Hernia Surgery
Comparison Between Lumbar Paravertebral and Field Blocks in Pediatric Inguinal Hernia Surgery.
調査の概要
詳細な説明
Different anesthetic regional techniques can be used for anesthesia and analgesia of the lower abdominal surgeries such as caudal, spinal, epidural, transversus abdominis plane block, ilioinguinal nerve block, lumbar plexus block, the field block and abdominal paravertebral block. The use of regional anesthesia with ultrasound guidance can help decrease complications of regional blocks.
In the lumbar area, the lumbar paravertebral space is a potential space formed by the vertebral bodies, intervertebral discs and intervertebral foramina medially, the psoas major muscle anterolaterally and the erector spinae muscles, the transverse process and intertransverse ligaments posteriorly. There is no costotransverse ligament in the lumbar region. The lumbar spinal nerve roots run through the paravertebral space then continue through the psoas major muscle where they form the lumbar plexus.The spinal nerves in this space are devoid of a fascial sheath making them exceptionally susceptible to local anesthetics. The diaphragm and psoas muscle separate the thoracic and lumbar paravertebral areas; however, communication may occur via the medial and lateral arcuate ligaments of the diaphragm.
Field block can be done by subcutaneous injection of a local anesthetic in an area bordering on the field to be anesthetized. It is safe, simple, effective, and economical, without post anesthesia side effects. Furthermore, local anesthesia administered before the incision produces longer postoperative analgesia because of local infiltration, theoretically, inhibits the build-up of local nociceptive molecules, and therefore, there is better pain control in the postoperative period.
The aim of this study is to compare the analgesic and autonomic effects of unilateral abdominal ultrasound guided paravertebral block with field block in pediatric inguinal hernia surgery.
This study hypothesizes that unilateral abdominal ultrasound guided paravertebral block may be more superior to field block in reducing intra and postoperative pain in the pediatric inguinal hernia. The analgesic efficacy and duration of ultrasound (US) guided unilateral lumbar paravertebral block and field block were compared when dexmedetomidine and epinephrine were added as adjuvants to bupivacaine.
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
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Dakahlia
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Mansoura、Dakahlia、エジプト、35516
- Mansoura University Children's Hospital
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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:
- Patients subjected to an elective unilateral inguinal hernia repair.
- American Society for Anesthesiologists physical status grades I and II.
Exclusion Criteria:
1. Parental refusal. 2. Neuromuscular diseases (as myopathies, myasthenia gravies, etc.) 3. Hematological diseases, bleeding or coagulation abnormality. 4. Psychiatric diseases. 5. Local skin infection and sepsis at the site of the block. 6. Known intolerance to the study drugs.
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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 |
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アクティブコンパレータ：Lumbar paravertebral group
After general anesthesia, the patient is placed prone.
To establish the level of the block, we used US-counting of vertebrae.
After determining the lumbar one level, the block performed at a parallel line 2 cm lateral to the spinous process, the transducer is moved until the corresponding transverse process is identified.
Utilizing an in-plane approach from lateral to medial, a spinal needle is advanced until contact with the transverse process.
The needle is withdrawn and redirected caudally under the transverse process helped by the loss of resistance technique.
the solution is slowly injected after negative aspiration for blood.
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A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
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アクティブコンパレータ：The field block group
The ilioinguinal nerve block was done at one fingerbreadth from the anterior superior iliac spine in a line with the pubic tubercle, The injection was done after the bob of the needle after passing the external oblique aponeurosis and muscle and 5ml of the solution is injected.
The rest of the solution is injected in the incision line.
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A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
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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 |
|---|---|---|
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The total dose of analgesics required in the post-operative periods
時間枠：24 hours postoperatively
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Fentanyl in microgram.
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24 hours postoperatively
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Modified Faces Legs Activity Cry Consolability Revised pain Scale
時間枠：postoperative at 1, 2, 4, 8,16, 24 hours.
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pain score of 5 items (Faces, Legs, Activity, Cry, Consolability) each of 0, 1, or 2 points.
0= express no pain, 1= mild pain, 2= the highest pain indicator.
A total score 0 = Relaxed and comfortable.
1-3 = Mild discomfort.
4-6 = Moderate pain.
7-10 = Severe pain.
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postoperative at 1, 2, 4, 8,16, 24 hours.
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Mean Blood pressure
時間枠：Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
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millimeter mercury
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Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
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Heart rate
時間枠：Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
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beat/minutes
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Basal preoperative, during incision, 30 minutes, 60 minutes intraoperatively, postoperative at 1, 2, 4, 8,16, 24 hours.
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Modified Ramsay sedation scale.
時間枠：postoperative at 2, 4, 6, 12, 16, 24 hours.
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a scale from (1- 6), 1 = anxious; 2 = oriented & tranquil; 3 = sedated, but responds to commands; 4 = asleep, brisk glabellar reflex or response to loud noise; 5 = asleep, slugglish glabellar reflex or response to loud noise; 6 = asleep with no response to painful stimulus
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postoperative at 2, 4, 6, 12, 16, 24 hours.
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Parents' satisfaction score
時間枠：postoperative after 24 hours.
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in a visual analogue score from (0-10), 0= minimal satisfaction, 10 = the highest satisfaction.
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postoperative after 24 hours.
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Adverse effects including nausea and vomiting, bradycardia (heart rate less than 60 beat/minute)
時間枠：postoperatively in the first 24 hours.
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percent
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postoperatively in the first 24 hours.
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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 (実際)
研究の完了 (実際)
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最初に提出
QC基準を満たした最初の提出物
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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
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
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
- SAP
- CSR
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術後の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Lumbar paravertebral groupの臨床試験
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Riphah International Universityまだ募集していません
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Riphah International Universityまだ募集していません
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Mansoura Universityまだ募集していません
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University Hospital, BordeauxBiom'Up France SAS完了