Study of Postoperative ICC Analgesia

University Hospital, Basel, Switzerland32 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postoperative Analgesia

Interventions

RopivacainDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel, Department of Thoracic Surgery

Basel, Switzerland

Outcomes

Primary Outcomes

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

Time frame: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure

Secondary Outcomes

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

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

number of daily postoperative pain killer consumption

Time frame: within 72 ± 2 hours postoperative

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.

Time frame: within 72 ± 2 hours postoperative

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 peek expiratory flow (PEF)

Data from ClinicalTrials.gov

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