Study of Postoperative ICC Analgesia

NCT04939545 | Completed Phase 3

• 1 other identifier: 2021-00922; kt21Lardinois
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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)

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (12)

• 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

• number of daily postoperative pain killer consumption

  within 72 ± 2 hours postoperative

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

  within 72 ± 2 hours postoperative

• 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 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

Study Arms (2)

Experimental Intervention Ropivacain

EXPERIMENTAL

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.

Drug: Ropivacain

Control Intervention Placebo

PLACEBO COMPARATOR

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.

Drug: NaCl 0.9%

Interventions

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.

Experimental Intervention Ropivacain

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.

Control Intervention Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Department of Thoracic Surgery

Basel, 4031, Switzerland

Location

Related Publications (1)

• Hojski A, Kramer M, Gecas P, Djakovic Z, Tsvetkov N, Mallaev M, Bolliger D, Lampart A, Lardinois D. The efficacy of loco-regional ropivacaine analgesia via intercostal catheters after lung resection: a randomized, double-blind, placebo-controlled, superiority study. Eur J Cardiothorac Surg. 2024 Oct 1;66(4):ezae342. doi: 10.1093/ejcts/ezae342.

  PMID: 39352775 DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Didier Lardinois, Prof. Dr. med.

  University Hospital Basel, Division of Thoracic Surgery

  STUDY CHAIR

• Aljaz Hojski, Dr. med.

  University Hospital Basel, Division of Thoracic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators, care providers, data analyst and trial participants are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, placebo-controlled, randomised, double-blind, superiority

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 25, 2021
• Study Start: December 15, 2021
• Primary Completion: March 20, 2023
• Study Completion: October 20, 2023
• Last Updated: October 24, 2023

Record last verified: 2023-10

Locations

CH (1)