- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04939545
Study of Postoperative ICC Analgesia (SPICA)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Good control of the pain without excessive use of opiates supports the benefits of minimally invasive surgical procedure.
This study is to examine the efficacy of continuously via surgically placed intercostal catheter administered ropivacaine at a flow rate of 6-8 ml/h of 2 mg/ml on post-operative pain (NRS) and pulmonary function (FEV1, PEF) during a maximum of 72 ± 2 hours after skin closure. Patients undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia with confirmed or anticipated Stage I Lung cancer will be included. The study will be conducted as superiority, double-blind, placebo-controlled, randomized. The efficacy of loco-regional administered ropivacaine will be compared to placebo (NaCl, 0.9%) administration. The whole study period per participant is expected to be 6 months. In the follow-up, 6 months after surgery, the impact of ropivacaine on long-term pain (NRS, McGill) and pulmonary function (FEV1, PEF) shall be evaluated.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Aljaz Hojski, Dr. med.
- Phone Number: +41 61 556 52 82
- Email: aljaz.hojski@usb.ch
Study Contact Backup
- Name: Didier Lardinois, Prof. Dr. med.
- Phone Number: +41 61 328 77 99
- Email: didier.lardinois@usb.ch
Study Locations
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Basel, Switzerland, 4031
- University Hospital Basel, Department of Thoracic Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Intervention Ropivacain
Ropivacain Fresenius 0.2% is a solution for infusion/ injection and will be continuously administered with an elastomer pump through the surgically placed intercostal catheter (ICC) between parietal pleura and fascia endo-thoracica at the level of surgical incision for a maximum of 72 hours at an initial standard flow rate setting of 6 ml/h using 2 mg/ml ropivacaine.
In case pain exceeds 7 on NRS later than 2 hours after skin closure the flow rate will be adjusted on 8 ml/h.
Furthermore, Ropivacain Fresenius 0.2% will be provided in a 20 ml glass vial for flushing the infusion line and subpleural administration.
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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. |
Placebo Comparator: Control Intervention Placebo
Placebo (NaCl 0.9% B. Braun) is an isotonic solution for infusion and will be continuously administered with an elastomer pump through the surgically placed intercostal catheter (ICC) between parietal pleura and fascia endo-thoracica at the level of surgical incision for a maximum of 72 hours at an initial standard flow rate setting of 6 ml/h using NaCl 0.9%.
In case pain exceeds 7 on NRS later than 2 hours after skin closure the flow rate will be adjusted on 8 ml/h.
Furthermore, NaCl 0.9% will be provided in a 20 ml glass vial for flushing the infusion line and for subpleural administration, which will be prepared by the hospital pharmacy.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in pain numerical rating scale (NRS) while coughing
Time Frame: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
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change in pain NRS (scale 0-10) while coughing in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable
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before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in pain NRS at rest
Time Frame: before surgery, at 2, 4, 8, 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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change in pain NRS at rest in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable
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before surgery, at 2, 4, 8, 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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number of daily postoperative pain killer consumption
Time Frame: within 72 ± 2 hours postoperative
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number of daily postoperative pain killer consumption
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within 72 ± 2 hours postoperative
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change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.
Time Frame: within 72 ± 2 hours postoperative
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Silverman integrating approach (SIA) score is a combined score from the pain numerical rating scale (NRS) and analgesics (opiate) usage.
It is a sum of rank- based percentage differences from the mean rank in pain scores and opioid use, ranging from -200 to 200%.
SIA-scores integrate pain scores and opioid use for the individual patient.
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within 72 ± 2 hours postoperative
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change in forced expiratory volume in 1 second (FEV1)
Time Frame: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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change in forced expiratory volume in 1 second (FEV1)
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before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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change in peek expiratory flow (PEF)
Time Frame: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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change in peek expiratory flow (PEF)
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before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
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change in the short-form McGill Questionnaire (SF-MPQ)
Time Frame: before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery
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The SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Three pain scores are derived from the sum of the intensity rank values of the words chosen for sensory, affective and total descriptors.
The SF-MPQ also includes the Present Pain Intensity (PPI) index of the standard MPQ and a 10 cm visual analogue scale (VAS), 0 = no pain to 10 = worst pain imaginable.
The higher the integrated score, the higher the pain level.
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before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery
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Patient Controlled Analgesia (PCA) demand
Time Frame: within 72 ± 2 hours postoperative
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PCA demand (Consumption of intravenous opiate)
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within 72 ± 2 hours postoperative
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duration of chest tube chest tube
Time Frame: within 72 ± 2 hours postoperative
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duration of chest tube
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within 72 ± 2 hours postoperative
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length of hospital stay
Time Frame: in the average within 30 days postoperative
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number of days in hospital postoperative
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in the average within 30 days postoperative
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30 day mortality
Time Frame: within 30 days postoperative
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30 day mortality
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within 30 days postoperative
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number of gastrointestinal tract events
Time Frame: within 72 ± 2 hours postoperative
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postoperative nausea and vomiting
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within 72 ± 2 hours postoperative
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time to first defecation
Time Frame: in the average within 30 days postoperative
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time to first defecation
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in the average within 30 days postoperative
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Collaborators and Investigators
Investigators
- Study Chair: Didier Lardinois, Prof. Dr. med., University Hospital Basel, Division of Thoracic Surgery
- Principal Investigator: Aljaz Hojski, Dr. med., University Hospital Basel, Division of Thoracic Surgery
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-00922; kt21Lardinois
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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