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Study of Postoperative ICC Analgesia (SPICA)

Primary Purpose

Postoperative Analgesia

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacain
NaCl 0.9%
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Analgesia focused on measuring Surgically Placed Intercostal Catheter (ICC), minimally invasive anatomical lung resection, ropivacaine, loco-regional analgesia, thoracic analgesia, Video-assisted thoracoscopic surgery (VATS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel, Department of Thoracic Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Intervention Ropivacain

Control Intervention Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
number of daily postoperative pain killer consumption
number of daily postoperative pain killer consumption
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.
change in forced expiratory volume in 1 second (FEV1)
change in forced expiratory volume in 1 second (FEV1)
change in peek expiratory flow (PEF)
change in peek expiratory flow (PEF)
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.
Patient Controlled Analgesia (PCA) demand
PCA demand (Consumption of intravenous opiate)
duration of chest tube chest tube
duration of chest tube
length of hospital stay
number of days in hospital postoperative
30 day mortality
30 day mortality
number of gastrointestinal tract events
postoperative nausea and vomiting
time to first defecation
time to first defecation

Full Information

First Posted
June 9, 2021
Last Updated
October 23, 2023
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT04939545
Brief Title
Study of Postoperative ICC Analgesia
Acronym
SPICA
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
March 20, 2023 (Actual)
Study Completion Date
October 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Analgesia
Keywords
Surgically Placed Intercostal Catheter (ICC), minimally invasive anatomical lung resection, ropivacaine, loco-regional analgesia, thoracic analgesia, Video-assisted thoracoscopic surgery (VATS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Prospective, placebo-controlled, randomised, double-blind, superiority
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All investigators, care providers, data analyst and trial participants are blinded
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Intervention Ropivacain
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Intervention Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacain
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
NaCl 0.9%
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in pain numerical rating scale (NRS) while coughing
Description
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
Time Frame
before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
Secondary Outcome Measure Information:
Title
change in pain NRS at rest
Description
change in pain NRS at rest in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable
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
Title
number of daily postoperative pain killer consumption
Description
number of daily postoperative pain killer consumption
Time Frame
within 72 ± 2 hours postoperative
Title
change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.
Description
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.
Time Frame
within 72 ± 2 hours postoperative
Title
change in forced expiratory volume in 1 second (FEV1)
Description
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
Title
change in peek expiratory flow (PEF)
Description
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
Title
change in the short-form McGill Questionnaire (SF-MPQ)
Description
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.
Time Frame
before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery
Title
Patient Controlled Analgesia (PCA) demand
Description
PCA demand (Consumption of intravenous opiate)
Time Frame
within 72 ± 2 hours postoperative
Title
duration of chest tube chest tube
Description
duration of chest tube
Time Frame
within 72 ± 2 hours postoperative
Title
length of hospital stay
Description
number of days in hospital postoperative
Time Frame
in the average within 30 days postoperative
Title
30 day mortality
Description
30 day mortality
Time Frame
within 30 days postoperative
Title
number of gastrointestinal tract events
Description
postoperative nausea and vomiting
Time Frame
within 72 ± 2 hours postoperative
Title
time to first defecation
Description
time to first defecation
Time Frame
in the average within 30 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Lardinois, Prof. Dr. med.
Organizational Affiliation
University Hospital Basel, Division of Thoracic Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Aljaz Hojski, Dr. med.
Organizational Affiliation
University Hospital Basel, Division of Thoracic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Department of Thoracic Surgery
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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Study of Postoperative ICC Analgesia

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