Acute AbdomenNCT07099924
Rectus Sheath Catheters Following Midline Laparotomy
A study testing Ropivacaine 0.2% and Saline 0.9% in people with Acute Abdomen and Ileus, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen, Ileus, Colorectal Carcinoma
- What is being tested?
- Ropivacaine 0.2% and Saline 0.9%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- 6 Oct 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Median laparotomy
- Age over 18 years
- Informed consent has been obtained
Who cannot join
- 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
Show all 9Show fewer
- pregnancy
- participation in another medical study
- sepsis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Asklepios Medical Center Uckermark
Schwedt, Brandenburg, 16303
Rüdiger Heicappell, Prof., +493332530, aerztlichedirektion.Schwedt@asklepios.com
Torsten Joerres, t.joerres@asklepios.com
About this study
Official title: Bilateral Rectus Sheath Catheters Following Midline Laparotomy. A Randomized, Placebo-controlled 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.
Read the detailed description
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).
- Conditions
- Acute Abdomen, Ileus, Colorectal Carcinoma
- Being tested
- Ropivacaine 0.2%, Saline 0.9%
- Keywords
- postoperative analgesia, rectus sheath catheter, ultrasound, midline laparotomy
- Medical subject headings
- Abdomen, Acute, Ileus, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.2%Drug
Also called local anesthetic
2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter
Saline 0.9%Drug
Also called placebo
2x30ml saline 0.9% every 8 hours via rectus sheath catheter
| Study group | Role | What they receive |
|---|---|---|
| ropivacaine 0.2% | Experimental | 2x30 ml (bilateral) ropivacaine 0.2% every 8 hours Receives: Drug: Ropivacaine 0.2% |
| saline 0.9% | Placebo comparator | 2x30 ml (bilateral) saline 0.9% every 8 hours Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient satisfaction
Quality-of-Recovery Score 15, minimum value 0, maximum value 150, higher values mean a better outcome
Measured: 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
Measured: daily up to 72 hours postoperatively
Opioid consumption
cumulative morphine equivalents
Measured: 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
Number of participants experiencing the following postoperative complications:
nausea and vomiting, constipation, respiratory failure, pneumonia, wound infections, wound dehiscence
Measured: up to 14 days from date of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start6 Oct 2025
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single center, randomized, placebo-controlled, observer-blinded
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asklepios Kliniken Hamburg GmbH
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Seidel, Asklepios Kliniken Hamburg GmbH
- Investigators
- Ronald Seidel, Dr.med., Principal investigator, Asklepios Klinikum Uckermark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099924
- Sponsor's protocol ID
- 2025-87-BO-ff
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Rectus Sheath Catheters Following Midline Laparotomy. A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07099924
- Acronym / sponsor ID
- 2025-87-BO-ff
- Conditions
- Acute Abdomen, Ileus, Colorectal Carcinoma
- Keywords
- postoperative analgesia, rectus sheath catheter, ultrasound, midline laparotomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Asklepios Kliniken Hamburg GmbHUniversity, hospital or other
- Study start
- 6 Oct 2025 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- single center, randomized, placebo-controlled, observer-blinded
| Arm | Type | Receives |
|---|---|---|
| ropivacaine 0.2% | Experimental | Drug: Ropivacaine 0.2%2x30 ml (bilateral) ropivacaine 0.2% every 8 hours |
| saline 0.9% | Placebo comparator | Drug: Saline 0.9%2x30 ml (bilateral) saline 0.9% every 8 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Median laparotomy
- Age over 18 years
- Informed consent has been obtained
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.2%Also: local anesthetic2x30ml (bilateral) ropivacaine 0.2% every 8 hours via rectus sheath catheter | Drug | ropivacaine 0.2% |
| Saline 0.9%Also: placebo2x30ml saline 0.9% every 8 hours via rectus sheath catheter | Drug | saline 0.9% |
Primary outcome
patient satisfaction
Time frame: 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)
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
Opioid consumption
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
1 secondary outcome
postoperative complications
Time frame: up to 14 days from date of randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald Seidel, Dr.med. principal investigator
Asklepios Klinikum Uckermark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ropivacaine 0.2% and Saline 0.9% in people with Acute Abdomen and Ileus, run by Asklepios Kliniken Hamburg GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ronald Seidel, Dr.med. (+49 3332 534521, ro.seidel@asklepios.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient satisfaction (time frame: on first postoperative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.