Clinical trial NCT02256228: Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery
Official title: Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Göteborg University
Sponsor class: OTHER
First posted: 2014-10-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Inflammatory Markers
timeFrame: 0-48 hours postoperatively
Secondary outcomes:
measure: Postoperative Morphine consumption
timeFrame: 0-48 hours postoperatively
measure: Pain Intensity
timeFrame: 0-48 hours postoperatively
measure: Cognitive Function
timeFrame: 0-1 month postoperatively
measure: Progression-free Survival
timeFrame: 0-3 years postoperatively
measure: Postoperative Morbidity/Complications
timeFrame: 0-30 days postoperatively
Other outcomes:
Locations:
city: Goteborg
country: Sweden
facility: Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital
Study officials:
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Sven-Egron Thorn, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
name: Anil Gupta, MD PhD
role: STUDY_CHAIR
affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
name: Sven-Erik Ricksten, MD PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.