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Clinical trial

Efficacy of Surgically Placed Intercostal Catheter (ICC) for Postoperative Analgesia After Minimally Invasive Anatomical Lung Resection Using Ropivacaine: A Randomised, Double-blind, Placebocontrolled, Superiority Study

ID
Name
2021-00922; kt21Lardinois
Description
This study is to examine the analgesic effectiveness of continuous loco-regional analgesic application (ropivacaine) through surgically placed Intercostal Catheter (ICC) and to establish correctly this method as a possible standard of care in the postoperative analgesia after Video-assisted thoracoscopic surgery (VATS) anatomical lung resection.
Trial arms
Trial start
2021-12-15
Estimated PCD
2023-03-20
Trial end
2023-10-20
Status
Completed
Phase
Early phase I
Treatment
Ropivacain
Intercostal continuous loco-regional ropivacaine (2 mg/ml) administration over an elastomeric pump through a surgically placed intercostal catheter (ICC) for a maximum of 72h. As concomitant treatments a standardized anesthesia protocol including intravenous continuous application of propofol and remifentanil is used. Additionally, i.v. metamizol at a dose of 1 g will be administered at the end of surgery as a standard, if not contraindicated. In a standardized postoperative pain protocol the use of basic oral medication is documented as part of the postoperative follow-up and consists of: ibuprofen 3 x 400 mg p. o. for 3 days, metamizol 4 x 1 g p. o. for 3 days; if ibuprofen and/or metamizol contraindicated then paracetamol p. o. 3 x 1g for 3 days will be administered; morphine 10 mg p. o. 6 times daily will be given on a patient demand basis.
Arms:
Experimental Intervention Ropivacain
NaCl 0.9%
Intercostal continuous loco-regional placebo solution (NaCl 0,9%) administration over an elastomeric pump through a surgically placed intercostal catheter (ICC) for a maximum of 72h. As concomitant treatments a standardized anesthesia protocol including intravenous continuous application of propofol and remifentanil is used. Additionally, i.v. metamizol at a dose of 1 g will be administered at the end of surgery as a standard, if not contraindicated. In a standardized postoperative pain protocol the use of basic oral medication is documented as part of the postoperative follow-up and consists of: ibuprofen 3 x 400 mg p. o. for 3 days, metamizol 4 x 1 g p. o. for 3 days; if ibuprofen and/or metamizol contraindicated then paracetamol p. o. 3 x 1g for 3 days will be administered; morphine 10 mg p. o. 6 times daily will be given on a patient demand basis.
Arms:
Control Intervention Placebo
Size
32
Primary endpoint
change in pain numerical rating scale (NRS) while coughing
before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
Eligibility criteria
Inclusion Criteria: * Informed Consent as documented by signature * Patient undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia for confirmed or anticipated Stage I lung cancer (UICC 8th edition) * American Society of Anesthesiologists (ASA) physical status classes I to III Exclusion Criteria: * NRS while coughing \> 0 * Previous ipsilateral thoracotomy or sternotomy * Abdominal or contralateral thoracic surgery up to 6 months preoperatively * Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product * Contraindications to self-administration of opioids * Women who are pregnant or breast feeding * Chronic steroid therapy (e.g. Prednisone \> 10mg/day for more than last 2 weeks before surgery) * Chronic, daily pain therapy * Congestive heart failure * Liver insufficiency * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Enrolment of the investigator, his/her family members, employees and other dependent person
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, placebo-controlled, randomised, double-blind, superiority', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'All investigators, care providers, data analyst and trial participants are blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2023-10-24

1 organization

2 products

1 indication

Organization
University Hospital Basel
Product
Ropivacain
Indication
Postoperative Analgesia
Product
NaCl