Rectus Sheath Catheters Following Midline Laparotomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepios Kliniken Hamburg GmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Median laparotomy
Age over 18 years
Informed consent has been obtained
Disqualifiers
Local signs of inflammation
known allergy to local anesthetics used
chronic pain syndrome
drug addiction
Trial design
Design model
Parallel
Treatments tested in this trial
Ropivacaine 0.2%
Drug2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter
Saline 0.9%
Drug2x30ml saline 0.9% every 8 hours via rectus sheath catheter
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ropivacaine 0.2%Experimental treatment 1 intervention
Group B: saline 0.9%Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
patient satisfaction
Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome
Time frame
on first postoperative day2
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 postoperatively3
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 daySecondary outcomes
1
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 randomizationSponsors and contacts
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Source ClinicalTrials.gov
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