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NCT Number: NCT02256228

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

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.

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Key information

Conditions

Pain Agnosia Neoplasms Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

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

Gothenburg, SE41385, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

Ropivacaine

Drug

Active Group

Other names: Narop

Saline

Drug

Placebo Comparator

Other names: Sodium Chloride

Primary outcomes

  1. Inflammatory Markers

    Time frame: 0-48 hours postoperatively

    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)

Secondary outcomes

  1. Postoperative Morphine consumption

    Time frame: 0-48 hours postoperatively

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

  2. Pain Intensity

    Time frame: 0-48 hours postoperatively

    Pain Intensity is measured with Numeric Rating Score 0-10

  3. Cognitive Function

    Time frame: 0-1 month postoperatively

    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)

  4. Progression-free Survival

    Time frame: 0-3 years postoperatively

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

  5. Postoperative Morbidity/Complications

    Time frame: 0-30 days postoperatively

    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)

Sponsors and collaborators

Lead sponsor

Göteborg University

Other

Registry information

Official study title

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

Acronym: IPLA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 3, 2014
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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