Improving pain management for minimal invasive surgery due to colon cancer using an ultrasound-guided nerve block.

Phase 1

• Conditions: Postoperative pain following laparoscopic hemicolectomy or sigmoidectomy due to coloncancer; MedDRA version: 20.0Level: LLTClassification code 10009951Term: Colon cancer NOSSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10078463Term: Laparoscopic partial colectomySystem Organ Class: 100000004865; MedDRA version: 20.1Level: LLTClassification code 10054711Term: Postoperative painSystem Organ Class: 100000004863; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-005200-96-DK
• Lead Sponsor: Associate Professor, Consultant Jens Børglum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-15
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

•Age > 18
•Scheduled for laparoscopic hemicolectomy or sigmoidectomy due to colon cancer
•Have received thorough information, oral and written, and signed the Informed Consent” form on participation in the trial
•ASA 1-3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Inability to cooperate
•Inability to speak and understand Danish
•Allergy to local anaesthetics or opioids
•Daily intake of opioids (evaluated by the investigators)
•Local infection at the site of injection or systemic infection
•Difficulty visualisation of muscular and fascial structures in ultrasound visualisation necessary to the block administration
•Pregnant* or breastfeeding
•Daily use of oral or intravenous steroids
•Known immune deficiency (evaluated by the investigators)
•Other simultaneous or previous cancer diagnosis (except non-melanoma skin cancer)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified