Continuous Wound Catheter Analgesia Associated With Intravenous Morphine PCA After Thoracotomy

NCT ID: NCT01698203

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-14
• Study Completion Date: 2018-10-11

Brief Summary

Objective: Epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. An alternative is continuous wound catheter analgesia. We will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. Methods: In a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 mL/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 mL/h for 48 h, or saline at the same scheme of administration. Patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. The primary endpoint will be total morphine consumption. Secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. Surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.

Conditions

Pain; Thoracotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ropivacaine

Group Type: EXPERIMENTAL

ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)

Intervention Type: DRUG

The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.

ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)

Intervention Type: DRUG

The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.

Interventions

ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)

The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.

Intervention Type: DRUG

Placebo

In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.

Intervention Type: DRUG

ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)

The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Patients scheduled for thoracotomy who presented with contraindications to TEA.

Contraindications to TEA are :

• Patient's refusal after informations about advantages and risks of the technique
• Anti platelets treatment that can't be discontinued
• Anticoagulants at a curative dosage
• haemostasis and/or coagulation disorders: thrombopenia < 100.000/mm3, ACT > 1,5 / control, PTT < 75%
• Systemic or local infection of the puncture point
• 2 and 3 grade atrio-ventricular heart block without pacing
• Severe aortic valve stenosis
• Kyphoscoliosis
• certain neurological disorders

Exclusion Criteria

• Patient's refusal to participate in the study
• Psychiatric disorder (impossibility to collect the informed consent)
• Patient under juridical protection
• On going an other study
• Pregnancy, breastfeeding
• Non balanced epilepsy
• 3 grade auriculo-ventricular heart block without pacing
• Severe hepatocellular insufficiency
• Anti arrhythmic treatment : class III of the Vaughan William's classification
• Skin infection of the puncture point
• Allergy to aminoamides local anaesthetic
• Surgical difficulties to insert paravertebral catheter

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Helms, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Hôpital Civil - NHC Département d'Anesthésiologie

Strasbourg, Alsace, France

Countries

France

References

Helms O, Mariano J, Hentz JG, Santelmo N, Falcoz PE, Massard G, Steib A. Intra-operative paravertebral block for postoperative analgesia in thoracotomy patients: a randomized, double-blind, placebo-controlled study. Eur J Cardiothorac Surg. 2011 Oct;40(4):902-6. doi: 10.1016/j.ejcts.2011.01.067. Epub 2011 Mar 5.

Reference Type: RESULT

PMID: 21377888 (View on PubMed)

Other Identifiers

5277

Identifier Type: -

Identifier Source: org_study_id