Rectus Sheath Catheters Following Midline Laparotomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Ropivacaine 0.2%: 2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter

Saline 0.9%: 2x30ml saline 0.9% every 8 hours via rectus sheath catheter

Study 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.

Eligibility

Primary outcome measure(s)

• patient satisfaction — on first postoperative day
  Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome
• pain score (numeric rating scale) — daily up to 72 hours postoperatively
  at rest and at movement, minimum value 0, maximum value 10, lower values mean a better outcome
• Opioid consumption — on the day of surgery, on the first postoperative day, on the second postoperative day, on the third postoperative day
  cumulative morphine equivalents

Trial sites (1)

Other trials for the same condition