Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

NCT02256228 | Completed Phase 3

• 1 other identifier: IPLA-CRS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

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

Outcome Measures

Primary Outcomes (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)

  0-48 hours postoperatively

Secondary Outcomes (5)

• Postoperative Morphine consumption

  0-48 hours postoperatively

• Pain Intensity

  0-48 hours postoperatively

• Cognitive Function

  0-1 month postoperatively

• Progression-free Survival

  0-3 years postoperatively

• Postoperative Morbidity/Complications

  0-30 days postoperatively

Study Arms (2)

Group R

ACTIVE COMPARATOR

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

Group P

PLACEBO COMPARATOR

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

Interventions

Ropivacaine DRUG

Active Group

Also known as: Narop

Group R

Saline DRUG

Placebo Comparator

Also known as: Sodium Chloride

Group P

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)

You may not qualify if:

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

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

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

Gothenburg, SE41385, Sweden

Location

Related Publications (2)

• 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.

  PMID: 32172954 DERIVED

• 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.

  PMID: 31206591 DERIVED

MeSH Terms

Conditions

Pain; Agnosia; Pain, Postoperative; Postoperative Complications; Neoplasms

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Sven-Egron Thorn, MD PhD

  Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 15, 2019

Record last verified: 2019-01

Locations

SE (1)