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AzTrials

PainPhase 3IPLANCT02256228

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

A Phase 3 study testing Ropivacaine and Saline in people with Pain, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study. Read more about this study

Who is it for?
Ages 18 to 74 years, women only
Conditions the study is for
Pain
What is being tested?
Ropivacaine and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSweden
Study dates
Oct 2014to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 to 74 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with widespread malignant intra-abdominal ovary cancer stadium III-IV and are operated by extensive resection of intra-abdominal viscera as well as the parietal peritoneum (cytoreductive surgery, CRS)

Who cannot join

  • Body mass index > 35
  • American Society of Anesthesiologists classification > 3
  • Renal dysfunction
  • Allergic to acetylsalicylic acid
  • Unwilling to provide informed consent

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital

    Gothenburg, SE41385

Other trials in Sweden

About this study

Official title: Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

Read the detailed description

The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study.

The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.

Conditions
Pain
Being tested
Ropivacaine, Saline
Keywords
Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, Intra-peritoneal analgesia, Ropivacaine, Saline, Therapeutic Uses, Analgesics, Non-Narcotic, Analgesics, Opioids, Morphine, Pain, Postoperative Complications, Physiological Effects of Drugs, Anesthetics, Local, Anesthetic, Cytoreductive, Surgery, Cancer
Medical subject headings
Pain, Agnosia, Pain, Postoperative, Postoperative Complications, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RopivacaineDrug

    Also called Narop

    Active Group

  • SalineDrug

    Also called Sodium Chloride

    Placebo Comparator

Study groups in NCT02256228
Study groupRoleWhat they receive
Group RActive comparatorRopivacaine is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Ropivacaine would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Ropivacaine (1mg/mL) would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.
Receives: Drug: Ropivacaine
Group PPlacebo comparatorSaline is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Saline would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inflammatory Markers

    Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1β, IL-1rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, zBasic FGF (Fibroblast Growth Factor), Eotaxin, G-CSF (granulocyte colony stimulating factor), GM-CSF granulocyte macrophage colony stimulating factor), IFN-γ (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1α (macrophage inflammatory protein), MIP-1β, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor), VEGF (vascular endothelial growth factor)

    Measured: 0-48 hours postoperatively

Secondary outcomes (5)

  1. Postoperative Morphine consumption

    Total amount of Morphine consumed during the first 48 hours after surgery

    Measured: 0-48 hours postoperatively

  2. Pain Intensity

    Pain Intensity is measured with Numeric Rating Score 0-10

    Measured: 0-48 hours postoperatively

  3. Cognitive Function

    Patients will complete the following neurophysiological tests upon entering the study and within one month after surgery: Verbal Learning Test (VLT), Concept Shifting Test (CST), Letter-Digit Coding, Verbal Learning Test - Delayed Recall (VLT-D)

    Measured: 0-1 month postoperatively

  4. Progression-free Survival

    Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.

    Measured: 0-3 years postoperatively

  5. Postoperative Morbidity/Complications

    Measuring the numbers of Postoperative Morbidity/Complications within one month after surgery:

    Morbidity:

    • Local infections
    • Urinary infection (urine culture)
    • Pneumonia (X-ray, C-reactive protein, Fever)
    • Sepsis (Fever, Leucocyte count in blood, Heart Rate, Respiratory Rate)
    • Pleural fluid (X-ray verified)
    • Deep Vein Thrombosis (D-dimer, ultrasound verified)
    • Pulmonary embolism (Computed Tomography/ Scint-X)
    • Acute Myocardial Infarction (Electrocardiography, Troponin I)
    • Atrial fibrillation or serious arrhythmia during the first 48 hours after surgery (Electrocardiography)
    • Respiratory failure (prolonged mechanical ventilation)
    • Renal failure (Serum Creatinine, Diuresis, AKIN criteria)
    • Inotropic needs > 12 hours after surgery

    Surgical Complications:

    • Intraabdominal bleeding
    • Leakage from anastomosis
    • Abdominal abscess
    • Paralytic ileus
    • Pancreatic leakage (requiring drainage)

    Measured: 0-30 days postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02256228
Sponsor's protocol ID
IPLA-CRS
Acronym
IPLA
Status last verified
Jan 2019
First submitted
1 Oct 2014
Last updated
15 Jan 2019
Results posted
No
Data monitoring committee
No

Publications

  • Nunez-Rodriguez E, Zhang H, Sah D, Cata JP. Intersection Between Local Anesthetics and Cancer Biology: What Now? Where Are We Going? Adv Biol (Weinh). 2025 Oct;9(10):e00122. doi: 10.1002/adbi.202500122. Epub 2025 Aug 7.

    PubMed 40772525

  • Hayden JM, Oras J, Block L, Thorn SE, Palmqvist C, Salehi S, Nordstrom JL, Gupta A. Intraperitoneal ropivacaine reduces time interval to initiation of chemotherapy after surgery for advanced ovarian cancer: randomised controlled double-blind pilot study. Br J Anaesth. 2020 May;124(5):562-570. doi: 10.1016/j.bja.2020.01.026. Epub 2020 Mar 13.

    PubMed 32172954

  • Hayden J, Gupta A, Thorn SE, Thulin P, Block L, Oras J. Does intraperitoneal ropivacaine reduce postoperative inflammation? A prospective, double-blind, placebo-controlled pilot study. Acta Anaesthesiol Scand. 2019 Sep;63(8):1048-1054. doi: 10.1111/aas.13410. Epub 2019 Jun 17.

    PubMed 31206591

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ropivacaine and Saline in people with Pain, run by Göteborg University at 1 site in Sweden.

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 1 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jan 2019. 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 Sweden. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Inflammatory Markers (time frame: 0-48 hours postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02256228, which also lists 3 linked publications.

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 15 Jan 2019.

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