Rectus Sheath Catheters Following Midline Laparotomy
NCT07099924 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-08-01
Summary
Rectus sheath catheters (RSC) are used for postoperative analgesia following midline laparotomies. Local anesthetics are applied to the posterior rectus sheath via the RSC. The target structures are the anterior cutaneous branches of the spinal nerves Th7-Th12. RSC can be used in particular if thoracic epidurals are contraindicated (compromised coagulation), technically unfeasible or refused by the patient.
The study investigates placebo-controlled weather RSC have a significant additional analgesic effect in a multimodal analgesic concept. Primary outcome parameters are the maximum pain score, the Quality-of-Recovery-15-Score (QoR-15GE) and the opioid consumption (morphine equivalents) in the first 72h postoperatively.
Conditions
- Acute Abdomen
- Ileus
- Colorectal Carcinoma
Interventions
- DRUG
-
Ropivacaine 0.2%
2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter
- DRUG
-
Saline 0.9%
2x30ml saline 0.9% every 8 hours via rectus sheath catheter
Sponsors & Collaborators
-
Asklepios Kliniken Hamburg GmbH
lead OTHER
Principal Investigators
-
Ronald Seidel, Dr.med. · Asklepios Klinikum Uckermark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-31
- Primary Completion
- 2027-08-31
- Completion
- 2027-09-30
Countries
- Germany
Study Locations
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