Study of Postoperative ICC Analgesia
- Conditions
- Postoperative Analgesia
- Interventions
- Drug: RopivacainDrug: NaCl 0.9%
- Registration Number
- NCT04939545
- Lead Sponsor
- University Hospital, Basel, Switzerland
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Intervention Ropivacain 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. Control Intervention Placebo 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.
- Primary Outcome Measures
Name Time Method change in pain numerical rating scale (NRS) while coughing 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 Outcome Measures
Name Time Method change in pain NRS at rest 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
change in forced expiratory volume in 1 second (FEV1) 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)
change in peek expiratory flow (PEF) 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 the short-form McGill Questionnaire (SF-MPQ) 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.
length of hospital stay in the average within 30 days postoperative number of days in hospital postoperative
30 day mortality within 30 days postoperative 30 day mortality
number of gastrointestinal tract events within 72 ± 2 hours postoperative postoperative nausea and vomiting
time to first defecation in the average within 30 days postoperative time to first defecation
number of daily postoperative pain killer consumption within 72 ± 2 hours postoperative number of daily postoperative pain killer consumption
change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption. 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.
Patient Controlled Analgesia (PCA) demand within 72 ± 2 hours postoperative PCA demand (Consumption of intravenous opiate)
duration of chest tube chest tube within 72 ± 2 hours postoperative duration of chest tube
Trial Locations
- Locations (1)
University Hospital Basel, Department of Thoracic Surgery
🇨🇭Basel, Switzerland