Postoperative AnalgesiaPhase 3SPICANCT04939545
Study of Postoperative ICC Analgesia
A Phase 3 study testing Ropivacain and NaCl 0.9% in people with Postoperative Analgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Ropivacain and NaCl 0.9%
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Dec 2021to 20 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Department of Thoracic Surgery
Basel, 4031
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Postoperative Analgesia
- Being tested
- Ropivacain, NaCl 0.9%
- Keywords
- Surgically Placed Intercostal Catheter (ICC), minimally invasive anatomical lung resection, ropivacaine, loco-regional analgesia, thoracic analgesia, Video-assisted thoracoscopic surgery (VATS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacainDrug
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.
NaCl 0.9%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention Ropivacain | Experimental | 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. Receives: Drug: Ropivacain |
| Control Intervention Placebo | Placebo comparator | 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. Receives: Drug: NaCl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain numerical rating scale (NRS) while coughing
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
Measured: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
Secondary outcomes (12)
change in pain NRS at rest
change in pain NRS at rest in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable
Measured: 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
number of daily postoperative pain killer consumption
number of daily postoperative pain killer consumption
Measured: within 72 ± 2 hours postoperative
change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.
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.
Measured: within 72 ± 2 hours postoperative
change in forced expiratory volume in 1 second (FEV1)
change in forced expiratory volume in 1 second (FEV1)
Measured: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
change in peek expiratory flow (PEF)
change in peek expiratory flow (PEF)
Measured: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
change in the short-form McGill Questionnaire (SF-MPQ)
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.
Measured: before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery
Patient Controlled Analgesia (PCA) demand
PCA demand (Consumption of intravenous opiate)
Measured: within 72 ± 2 hours postoperative
duration of chest tube chest tube
duration of chest tube
Measured: within 72 ± 2 hours postoperative
length of hospital stay
number of days in hospital postoperative
Measured: in the average within 30 days postoperative
30 day mortality
30 day mortality
Measured: within 30 days postoperative
number of gastrointestinal tract events
postoperative nausea and vomiting
Measured: within 72 ± 2 hours postoperative
time to first defecation
time to first defecation
Measured: in the average within 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start15 Dec 2021
- Primary completion20 Mar 2023
- Study completion20 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, placebo-controlled, randomised, double-blind, superiority
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Lardinois, Prof. Dr. med., Study chair, University Hospital Basel, Division of Thoracic SurgeryAljaz Hojski, Dr. med., Principal investigator, University Hospital Basel, Division of Thoracic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939545
- Sponsor's protocol ID
- 2021-00922; kt21Lardinois
- Acronym
- SPICA
- Status last verified
- Oct 2023
- First submitted
- 9 Jun 2021
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hojski A, Kramer M, Gecas P, Djakovic Z, Tsvetkov N, Mallaev M, Bolliger D, Lampart A, Lardinois D. The efficacy of loco-regional ropivacaine analgesia via intercostal catheters after lung resection: a randomized, double-blind, placebo-controlled, superiority study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae342. doi: 10.1093/ejcts/ezae342.
PubMed 39352775
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04939545
- Acronym / sponsor ID
- SPICA / 2021-00922; kt21Lardinois
- Conditions
- Postoperative Analgesia
- Keywords
- Surgically Placed Intercostal Catheter (ICC), minimally invasive anatomical lung resection, ropivacaine, loco-regional analgesia, thoracic analgesia, Video-assisted thoracoscopic surgery (VATS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Oct 2023 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, placebo-controlled, randomised, double-blind, superiority
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention Ropivacain | Experimental | Drug: RopivacainRopivacain 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. |
| Control Intervention Placebo | Placebo comparator | Drug: NaCl 0.9%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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacainIntercostal 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. | Drug | 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. | Drug | Control Intervention Placebo |
Primary outcome
change in pain numerical rating scale (NRS) while coughing
Time frame: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
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
12 secondary outcomes
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
number of daily postoperative pain killer consumption
Time frame: within 72 ± 2 hours postoperative
change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.
Time frame: within 72 ± 2 hours postoperative
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
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
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
Patient Controlled Analgesia (PCA) demand
Time frame: within 72 ± 2 hours postoperative
duration of chest tube chest tube
Time frame: within 72 ± 2 hours postoperative
length of hospital stay
Time frame: in the average within 30 days postoperative
30 day mortality
Time frame: within 30 days postoperative
number of gastrointestinal tract events
Time frame: within 72 ± 2 hours postoperative
time to first defecation
Time frame: in the average within 30 days postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Derived from this study: PubMed 39352775Hojski A, Kramer M, Gecas P, Djakovic Z, Tsvetkov N, Mallaev M, Bolliger D, Lampart A, Lardinois D. The efficacy of loco-regional ropivacaine analgesia via intercostal catheters after lung resection: a randomized, double-blind, placebo-controlled, superiority study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae342. doi: 10.1093/ejcts/ezae342.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Didier Lardinois, Prof. Dr. med. study chair
University Hospital Basel, Division of Thoracic Surgery
Aljaz Hojski, Dr. med. principal investigator
University Hospital Basel, Division of Thoracic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacain and NaCl 0.9% in people with Postoperative Analgesia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain numerical rating scale (NRS) while coughing (time frame: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.