Comparing pain relief techniques after abdominal surgery
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
NA · Centre Hospitalier Régional Metz-Thionville · NCT04985695
This study is testing two different pain relief methods after abdominal surgery to see which one helps patients recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Régional Metz-Thionville (other) |
| Locations | 2 sites (Metz, Moselle and 1 other locations) |
| Trial ID | NCT04985695 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial that compares two different locoregional anesthesia techniques for patients undergoing midline laparotomy. One group will receive epidural anesthesia, while the other will receive a bilateral rectus sheath block. The study aims to assess the impact of these analgesic techniques on postoperative recovery, specifically using the Quality of Recovery-15 score. The trial is multicentric and open-label, focusing on improving postoperative rehabilitation outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults classified as ASA Class I-IV who are scheduled for midline laparotomy and can provide informed consent.
Not a fit: Patients with contraindications to local anesthetics or epidural analgesia, as well as those with severe medical conditions or who are pregnant, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and faster recovery for patients after abdominal surgery.
How similar studies have performed: Previous studies have shown promising results with similar locoregional anesthesia techniques, suggesting potential benefits over traditional epidural analgesia.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA (American Society of Anesthesiologists) Class I-IV adult, with programmed midline laparotomy * Have given an informed written consent * Able to read and understand french language * Affiliation to a social security system Exclusion Criteria: * Local anesthesic contraindication (allergy, porphyria, haemolytic anaemia, uncontrolled epilepsy, or severe cardiac conduction disorders) or TEA (coagulation disorders, progressive neurological disease, or severe spinal disorder), * Epidural analgesia contraindication * With impossibility to set up bilateral rectus sheath block * Participation in another clinical study * Pregnant women * Patients deprived of their liberty by a judicial or administrative decision, * Patients undergoing psychiatric care under articles L.3212-1 and L.3213-1 of the French Public Health Code
Where this trial is running
Metz, Moselle and 1 other locations
- CHR Metz Thionville Hopital de Mercy — Metz, Moselle, France (RECRUITING)
- CHR Metz-Thionville Hopital Bel Air — Thionville, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Antoine BECRET, MD — CHR Metz Thionville Hopital de Mercy
- Study coordinator: Arpiné EL NAR, PhD
- Email: arpine.el-nar@chr-metz-thionville.fr
- Phone: 0033387557766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Laparotomy, postoperative rehabilitation