Rectus Sheath Catheters Following Midline Laparotomy

NCT07099924 | Not Yet Recruiting

• 1 other identifier: 2025-87-BO-ff
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

postoperative analgesia; rectus sheath catheter; ultrasound; midline laparotomy

Outcome Measures

Primary Outcomes (3)

• patient satisfaction

  Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome

  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

  daily up to 72 hours postoperatively

• Opioid consumption

  cumulative morphine equivalents

  on the day of surgery, on the first postoperative day, on the second postoperative day, on the third postoperative day

Secondary Outcomes (1)

• postoperative complications

  up to 14 days from date of randomization

Study Arms (2)

ropivacaine 0.2%

EXPERIMENTAL

2x30 ml (bilateral) ropivacaine 0.2% every 8 hours

Drug: Ropivacaine 0.2%

saline 0.9%

PLACEBO COMPARATOR

2x30 ml (bilateral) saline 0.9% every 8 hours

Drug: Saline 0.9%

Interventions

Ropivacaine 0.2% DRUG

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

Also known as: local anesthetic

ropivacaine 0.2%

Saline 0.9% DRUG

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

Also known as: placebo

saline 0.9%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Median laparotomy
• Age over 18 years
• Informed consent has been obtained

You may not qualify if:

• Local signs of inflammation
• known allergy to local anesthetics used
• chronic pain syndrome
• drug addiction
• post-operative ventilation that cannot be completed on the day of surgery
• lack of consent or cooperation
• pregnancy
• participation in another medical study
• sepsis

Sponsors & Collaborators

• Asklepios Kliniken Hamburg GmbH: lead

Study Sites (1)

Asklepios Medical Center Uckermark

Schwedt, Brandenburg, 16303, Germany

Location

MeSH Terms

Conditions

Abdomen, Acute; Ileus; Colorectal Neoplasms

Interventions

Anesthetics, Local; Sodium Chloride

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Colonic Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ronald Seidel, Dr.med.

  Asklepios Klinikum Uckermark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald Seidel, Dr.med.

CONTACT

+49 3332 534521; ro.seidel@asklepios.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Anesthesia and Intensive Care

Model Details: single center, randomized, placebo-controlled, observer-blinded

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: August 1, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: up to 6 months after publication
• Access Criteria: on request to the principal investigator

Locations

DE (1)