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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02256228
Date of registration:	01/10/2014
Prospective Registration:	Yes
Primary sponsor:	Göteborg University
Public title:	Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery IPLA
Scientific title:	Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
Date of first enrolment:	October 2014
Target sample size:	40
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02256228
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Sweden

Contacts

Name:	Anil Gupta, MD PhD
Address:
Telephone:
Email:
Affiliation:	Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden

Name:	Sven-Egron Thorn, MD PhD
Address:
Telephone:
Email:
Affiliation:	Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

Name:	Sven-Erik Ricksten, MD PhD
Address:
Telephone:
Email:
Affiliation:	Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 74 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Ropivacaine

Drug: Saline

Primary Outcome(s)

Inflammatory Markers [Time Frame: 0-48 hours postoperatively]

Secondary Outcome(s)

Postoperative Morphine consumption [Time Frame: 0-48 hours postoperatively]

Progression-free Survival [Time Frame: 0-3 years postoperatively]

Pain Intensity [Time Frame: 0-48 hours postoperatively]

Postoperative Morbidity/Complications [Time Frame: 0-30 days postoperatively]

Cognitive Function [Time Frame: 0-1 month postoperatively]

Secondary ID(s)

IPLA-CRS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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