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Completed

NCT Number: NCT04939545

Study of Postoperative ICC Analgesia

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.

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Key information

Conditions

Postoperative Analgesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Basel, Department of Thoracic Surgery

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacain

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    change in pain NRS at rest in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable

  2. number of daily postoperative pain killer consumption

    Time frame: within 72 ± 2 hours postoperative

    number of daily postoperative pain killer consumption

  3. change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.

    Time frame: within 72 ± 2 hours postoperative

    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.

  4. 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 forced expiratory volume in 1 second (FEV1)

  5. 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 peek expiratory flow (PEF)

  6. 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

    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.

  7. Patient Controlled Analgesia (PCA) demand

    Time frame: within 72 ± 2 hours postoperative

    PCA demand (Consumption of intravenous opiate)

  8. duration of chest tube chest tube

    Time frame: within 72 ± 2 hours postoperative

    duration of chest tube

  9. length of hospital stay

    Time frame: in the average within 30 days postoperative

    number of days in hospital postoperative

  10. 30 day mortality

    Time frame: within 30 days postoperative

    30 day mortality

  11. number of gastrointestinal tract events

    Time frame: within 72 ± 2 hours postoperative

    postoperative nausea and vomiting

  12. time to first defecation

    Time frame: in the average within 30 days postoperative

    time to first defecation

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: SPICA

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 25, 2021
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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