Postoperative Analgesia
Conditions
Keywords
Surgically Placed Intercostal Catheter (ICC), minimally invasive anatomical lung resection, ropivacaine, loco-regional analgesia, thoracic analgesia, Video-assisted thoracoscopic surgery (VATS)
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.
Interventions
DRUGRopivacain
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.
DRUGNaCl 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.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
All investigators, care providers, data analyst and trial participants are blinded
Intervention model description
Prospective, placebo-controlled, randomised, double-blind, superiority
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 |
| duration of chest tube chest tube | within 72 ± 2 hours postoperative | duration of chest tube |
| 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 |
| Patient Controlled Analgesia (PCA) demand | within 72 ± 2 hours postoperative | PCA demand (Consumption of intravenous opiate) |
Countries
Switzerland
Outcome results
None listed