Asklepios Medical Center Uckermark
Schwedt, Brandenburg, 16303, Germany
Location contact
Ronald Seidel, Dr.med.
PRINCIPAL_INVESTIGATOR
Rüdiger Heicappell, Prof.
CONTACT
Torsten Joerres
CONTACT
NCT Number: NCT07099924
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Schwedt, Brandenburg, 16303, Germany
Ronald Seidel, Dr.med.
PRINCIPAL_INVESTIGATOR
Rüdiger Heicappell, Prof.
CONTACT
Torsten Joerres
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter
Other names: local anesthetic
2x30ml saline 0.9% every 8 hours via rectus sheath catheter
Other names: placebo
Time frame: on first postoperative day
Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome
Time frame: daily up to 72 hours postoperatively
at rest and at movement, minimum value 0, maximum value 10, lower values mean a better outcome
Time frame: on the day of surgery, on the first postoperative day, on the second postoperative day, on the third postoperative day
cumulative morphine equivalents
Time frame: up to 14 days from date of randomization
Number of participants experiencing the following postoperative complications:
nausea and vomiting, constipation, respiratory failure, pneumonia, wound infections, wound dehiscence
Contact information is provided by the study sponsor or research team.
Asklepios Kliniken Hamburg GmbH
Other
Bilateral Rectus Sheath Catheters Following Midline Laparotomy. A Randomized, Placebo-controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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