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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Jonathan LEBHAR, Dr
- 전화번호: +332 23 25 30 70
- 이메일: jlebhar@vivalto-sante.com
연구 장소
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Saint-Grégoire, 프랑스, 35760
- 모병
- Centre hospitalier Privé Saint-Grégoire
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연락하다:
- Marion Mandon, PhD
- 전화번호: +33678277672
- 이메일: drc@vivalto-sante.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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다른: 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).
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2025-41-STG
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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