Laparotomy Clinical Trial
— QorRecCathOfficial title:
Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy: Comparison Between Thoracic Epidural Anesthesia Versus Bilateral Rectus Sheath Block
Randomized controlled trial (1:1) in two parallel groups, monocentric, open-label, comparing two locoregional anesthesia (LRA) techniques as integral parts of multimodal analgesia: the control group will benefit from epidural anesthesia, while the experimental group will benefit from bilateral placement of catheters in the sheath of the rectus abdominis muscles.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | April 10, 2026 |
Est. primary completion date | October 10, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHR Metz Thionville | Metz | Moselle |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in total QoR-15 score | The Quality of Recovery-15 (QoR-15) included five dimensions: physical comfort, emotional state, pain, psychological support and physical independence. Each item was assessed using an 11-point numerical rating scale (for positive itel, 0="none of the time" to 10="all the time"; for negative items the scoring was reversed). | Postoperative day 2 | |
Secondary | Efficacy of postoperative analgesia | The efficacy of postoperative analgesia was compared between the two groups with the visual analog scale (VAS). The VAS intensity rating consisted of a 100-mm line with the end points no pain (0 mm) and worst pain (100 mm). Study participants were asked to evaluated with a mark on the line their current pain intensity. The difference between each postoperative treatment VAS score was compared. | Postoperative days 1, 2, 3 and 30 | |
Secondary | Impact of arterial hypotension | The impact of arterial hypotension was compared between the two groups with the arterial pressure value before and after laparotomy | Postoperative days 1, 2 and 3 | |
Secondary | Impact of orthostatic hypotension | The impact of orthostatic hypotension was compared between the two groups with the arterial pressure value before and after surgery. | Postoperative days 1, 2 and 3 | |
Secondary | Occurrence of nausea and/or vomiting | The effect of analgesic technique on nausea and/or vomiting is calculated on the basis of the number of anti-vomiting prescribed. | Postoperative days 1, 2 and 3 | |
Secondary | Postoperative complications link to analgesic technique | Number of postoperative complication in both groups | Postoperative days 1, 2 and 3 | |
Secondary | The length of stay | Comparison of the length of stay between the two groups | Postoperative day 30 | |
Secondary | Return to normal bowel function | Delay in hours to promotes normal digestive activity. The included the times to recovery the first bowel sounds, first anal exhaust and defecation. | Postoperative days 1, 2 and 3 | |
Secondary | The quantity of morphine or equivalent | The quantity of morphine or equivalent administered during the 48 first hours in both groups | Postoperative days 1 and 2 | |
Secondary | Urinary catheterization | The time during which the patients are taking recourse to postoperative urinary catheterization | Postoperative days 1, 2 and 3 | |
Secondary | Total distance covered | Compare the impact of postoperative analgesia in Walking distance within days following the operation | Postoperative days 1, 2 and 3 | |
Secondary | Failure to set up a catheter | Number of Failure to delivery catheter in both techniques | Postoperative day 1 | |
Secondary | The time until the first raised | Delay before the first raised in hours | Postoperative days 1, 2 and 3 |
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