Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

Pain Clinical Trial

— IPLA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02256228
• Other study ID #: IPLA-CRS
• Status: Completed
• Phase: Phase 3
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Ropivacaine
Active Group
• Saline
Placebo Comparator

Locations

Country	Name	City	State
Sweden	Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital	Goteborg

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Markers	Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1ß, IL-1ra, 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-? (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1a (macrophage inflammatory protein), MIP-1ß, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-a (tumor necrosis factor), VEGF (vascular endothelial growth factor)	0-48 hours postoperatively
Secondary	Postoperative Morphine consumption	Total amount of Morphine consumed during the first 48 hours after surgery	0-48 hours postoperatively
Secondary	Pain Intensity	Pain Intensity is measured with Numeric Rating Score 0-10	0-48 hours postoperatively
Secondary	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)	0-1 month postoperatively
Secondary	Progression-free Survival	Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.	0-3 years postoperatively
Secondary	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)	0-30 days postoperatively