Clinical trial NCT04939545: Study of Postoperative ICC Analgesia
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
Overall status: COMPLETED
Phase: PHASE3
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)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, placebo-controlled, randomised, double-blind, superiority
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in pain numerical rating scale (NRS) while coughing
timeFrame: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
Secondary outcomes:
measure: change in pain NRS at rest
timeFrame: 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
measure: number of daily postoperative pain killer consumption
timeFrame: within 72 ± 2 hours postoperative
measure: change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.
timeFrame: within 72 ± 2 hours postoperative
measure: change in forced expiratory volume in 1 second (FEV1)
timeFrame: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
measure: change in peek expiratory flow (PEF)
timeFrame: before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery
measure: change in the short-form McGill Questionnaire (SF-MPQ)
timeFrame: before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery
measure: Patient Controlled Analgesia (PCA) demand
timeFrame: within 72 ± 2 hours postoperative
measure: duration of chest tube chest tube
timeFrame: within 72 ± 2 hours postoperative
measure: length of hospital stay
timeFrame: in the average within 30 days postoperative
measure: 30 day mortality
timeFrame: within 30 days postoperative
measure: number of gastrointestinal tract events
timeFrame: within 72 ± 2 hours postoperative
measure: time to first defecation
timeFrame: in the average within 30 days postoperative
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Department of Thoracic Surgery
Study officials:
affiliation: University Hospital Basel, Division of Thoracic Surgery
name: Didier Lardinois, Prof. Dr. med.
role: STUDY_CHAIR
affiliation: University Hospital Basel, Division of Thoracic Surgery
name: Aljaz Hojski, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: