Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery (DISCOPAIN)
The lifetime prevalence of lumbosacral radiculopathy is 3 to 5 percent. The most common cause is a lumbar disc herniation. In 10 to 20 percent of patients, medical treatment is insufficient, and surgery is recommended. Lumbar discectomy is the standard surgical treatment. In recent years, minimally invasive techniques-and endoscopic approaches in particular-have become widely adopted.
The main advantage of these techniques lies in their reduced invasiveness, which allows for the preservation of muscle and ligament structures, with less extensive detachment and cutting. This preservation is likely to enable faster rehabilitation during the first few weeks and months after surgery, as well as a shorter hospital stay.
However, the available data focus primarily on medium- and long-term outcomes, and few studies have specifically examined early postoperative pain. Yet this immediate period is a critical factor, particularly regarding patient comfort, analgesic use, and length of hospital stay; it is a major determinant of the quality of immediate recovery. There is very little robust comparative data from real-world clinical settings evaluating the impact of surgical technique on early postoperative pain following lumbar discectomy.
In this context, this study aims to compare changes in short-term low back pain intensity following lumbar discectomy, depending on the technique used (endoscopic versus conventional open surgery), under real-world clinical conditions.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Jonathan LEBHAR, Dr
- 電話番号：+332 23 25 30 70
- メール：jlebhar@vivalto-sante.com
研究場所
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Saint-Grégoire、フランス、35760
- 募集
- Centre hospitalier Privé Saint-Grégoire
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コンタクト：
- Marion Mandon, PhD
- 電話番号：+33678277672
- メール：drc@vivalto-sante.com
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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:
- Have had radicular and/or lower back pain for more than 6 weeks despite proper medical treatment, leading to the decision to schedule surgery
- Have symptoms consistent with an MRI showing a herniated disc
Exclusion Criteria:
- History of lumbar surgery
- Complex Regional Pain Syndrome (CRPS) type 1 or 2
- Multiple affected levels
- Cauda equina syndrome
- Unscheduled surgery
- Spondylolisthesis
- Significantly narrowed lumbar canal (Schizas C or D)
- Pregnant, laboring, or breastfeeding women
- Severe psychiatric disorder
- Unwilling subject who cannot give consent or cannot return for scheduled visits as per the protocol
- Person under legal protection (guardianship, conservatorship, or judicial safeguard)
- Person deprived of liberty by judicial or administrative order
- Person not covered by social security
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：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Endoscopis surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position.
After identifying the surgical site using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes).
The approach is percutaneous and transmuscular, using one channel for instruments and another for the endoscopic camera.
After exposing the spinal canal, the nerve root is identified and protected.
The herniated disc is then accessed following an incision in the posterior longitudinal ligament and resected using a disc forceps.
The procedure concludes with skin closure.
|
The procedure is performed under general anesthesia, with the patient in the knee-chest position.
After identifying the surgical site using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes).
The approach is percutaneous and transmuscular, using one channel for instruments and another for the endoscopic camera.
After exposing the spinal canal, the nerve root is identified and protected.
The herniated disc is then accessed following an incision in the posterior longitudinal ligament and resected using a disc forceps.
The procedure concludes with skin closure.
|
|
他の：Open surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position.
After identifying the surgical level using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes).
A skin incision is made to allow for a posterior approach with muscle dissection.
Recalibration is performed to expose the nerve structures.
The nerve root is identified and protected; the herniated disc is then accessed after incision of the posterior longitudinal ligament and resected using a disc forceps.
Closure is performed layer by layer (fascia, subcutaneous tissue, skin).
|
The procedure is performed under general anesthesia, with the patient in the knee-chest position.
After identifying the surgical level using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes).
A skin incision is made to allow for a posterior approach with muscle dissection.
Recalibration is performed to expose the nerve structures.
The nerve root is identified and protected; the herniated disc is then accessed after incision of the posterior longitudinal ligament and resected using a disc forceps.
Closure is performed layer by layer (fascia, subcutaneous tissue, skin).
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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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To compare, under real-world clinical conditions, changes in the intensity of short-term low back pain following lumbar discectomy, based on the surgical technique used: endoscopic versus open surgery
時間枠：day 3
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Change in lumbar Visual Analog Scale (VAS) between preoperative and Day 3. VAS provides a pain intensity score out of 10, 0 representing "no pain" and 10 representing "pain as bad as it could possibly be".
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day 3
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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
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