An interventional study of Ropivacaine 0.2% and Saline 0.9% in Acute Abdomen, Ileus and Colorectal Carcinoma, sponsored by Asklepios Kliniken Hamburg GmbH. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Asklepios Kliniken Hamburg GmbH · Not applicable, Interventional, and Treatment
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.
Recruitment Patients are recruited during the anesthesiology consultation. Patients who provided written informed consent. fulfill all inclusion and no exclusion criteria will be included in the study.
Allocation of study medication After inclusion in the study, each patient receives a patient number, which is noted on the Case Report Form (CRF). The randomization list was generated via www.random.org (Randomness and Integrity Services Ltd., Dublin, Ireland). Random assignment to groups 1 (verum) and 2 (placebo) was performed on the day of surgery using the sealed envelope technique. The sealed envelope is opened by a doctor not involved in the study immediately before bilateral placement of the rectus catheters catheters. This colleague prepares the study medication (verum or placebo, unlabeled, blinded to the observer and patient).
Anesthesia and perioperative monitoring After a peripheral or central venous line is inserted, a balanced electrolyte solution is connected and the following parameters are monitored until complete postoperative recovery: blood pressure (plethsymographic or via arterial line), electrocardiogram, pulse oximetry.
The surgical procedures are performed under general anesthesia (sevoflurane 0.7-1.0 MAC). Sufentanil (0.2-0.4 microg/kg), propofol (1.5-2 mg/kg) and cisatracurium (0.1-0.15 mg/kg) are administered to induce anesthesia The multimodal analgesia concept includes the intraoperative administration of 4 mg dexamethasone (antiemetic, coanalgesic) and two non-opioids: 1 g metamizole (40 mg parecoxib if contraindications exist) and 1 g paracetamol.
Study intervention Bilateral RSC are placed intraoperatively after closure of the median laparotomy under aseptic conditions, before the wound dressing is applied. For imaging, we use an ultrasound device (FUJIFILM Sonosite, Bothel, WA, USA) with a linear transducer (38mm, 6-13MHz), which is placed obliquely on the upper edge of the median laparotomy. The puncture (puncture direction from medial-cranial to lateral-caudal) is initially performed with an ultrasound-optimized single-shot cannula (SonoPlex 22G50mm to 21G100mm, Pajunk, Geisingen, Germany) in order to reliably identify the compartment of the posterior rectus sheath. After verification of the correct spread of the local anesthetic, the catheter (SonoLong Echo 19G 50-100mm, 20G 50cm catheter, Pajunk, Geisingen, Germany) is placed at the lateral edge of the posterior rectus sheath and again the correct spread of the local anesthetic in the target compartment is verified by ultrasound.
Group 1 Verum (ropivacaine 0.2%) Dosage 2x30ml ropivacaine 0.2% every 8h (120mg every 8h) Daily dose 360mg
Group 2 Placebo (saline 0.9%) Dosage 2x30ml saline 0.9% every 8h
Postoperative care Postoperatively, patients are cared for in the recovery room or intensive care unit. As soon as their condition allows, they are transferred to a peripheral ward. Non-opioid analgesics are continued. An additional opioid-based on-demand medication is prescribed (7.5 mg piritramid), the dose of which is documented as morphine equivalents (5 mg).
65 studies on the registry are indexed under Abdomen, Acute; 14 are open to participants now.
This study's planned enrollment of 40 is below the median of 188 across 26 interventional studies indexed under Abdomen, Acute.
Browse Abdomen, Acute studies →Asklepios Kliniken Hamburg GmbH is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2x30 ml (bilateral) ropivacaine 0.2% every 8 hours
Drug: Ropivacaine 0.2%
2x30 ml (bilateral) saline 0.9% every 8 hours
Drug: Saline 0.9%
2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter
Also known as: local anesthetic
2x30ml saline 0.9% every 8 hours via rectus sheath catheter
Also known as: placebo
patient satisfaction
Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome
Time frame: on first postoperative day
pain score (numeric rating scale)
at rest and at movement, minimum value 0, maximum value 10, lower values mean a better outcome
Time frame: daily up to 72 hours postoperatively
Opioid consumption
cumulative morphine equivalents
Time frame: on the day of surgery, on the first postoperative day, on the second postoperative day, on the third postoperative day
postoperative complications
Number of participants experiencing the following postoperative complications: nausea and vomiting, constipation, respiratory failure, pneumonia, wound infections, wound dehiscence
Time frame: up to 14 days from date of randomization
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: up to 6 months after publication
Access criteria: on request to the principal investigator
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Aug 2027, 22 months after the start.
Start moved once since we started tracking on Sep 25, 2026: Jul 2025 → Oct 2025, on Oct 28, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Ropivacaine
Asklepios Kliniken Hamburg GmbH