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Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery (IPLA)

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ClinicalTrials.gov Identifier: NCT02256228
Recruitment Status : Completed
First Posted : October 3, 2014
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Göteborg University

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Ropivacaine Drug: Saline Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
Study Start Date : October 2014
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Arm Intervention/treatment
Active Comparator: Group R
Ropivacaine 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.
Drug: Ropivacaine
Active Group
Other Name: Narop

Placebo Comparator: Group P
Saline 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.
Drug: Saline
Placebo Comparator
Other Name: Sodium Chloride




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02256228


Locations
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Sweden
Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital
Goteborg, Sweden, SE41385
Sponsors and Collaborators
Göteborg University
Investigators
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Principal Investigator: Sven-Egron Thorn, MD PhD Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
Study Chair: Anil Gupta, MD PhD Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
Study Chair: Sven-Erik Ricksten, MD PhD Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT02256228     History of Changes
Other Study ID Numbers: IPLA-CRS
First Posted: October 3, 2014    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

Keywords provided by Göteborg University:
Cancer
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

Additional relevant MeSH terms:
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Anesthetics
Ropivacaine
Analgesics
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents