Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

NCT01320475 | Terminated Phase 4

• 1 other identifier: 2009/04
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic. The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.

Conditions

Thoracic Surgery

Keywords

thoracic epidural analgesia; epidural opioid; ketamine; adverse effect

Outcome Measures

Primary Outcomes (2)

• Occurrence of an adverse event due to the analgesic protocol

  one week

• Efficacy of the analgesic regimen

  third postoperative day

Secondary Outcomes (5)

• postoperative rehabilitation

  two weeks

• postoperative complications (pulmonary, others)

  one month

• length of stay

  one month

• patient's satisfaction

  sortie de l'hopital

• Occurence of a chronic pain

  end the first postoperative year

Study Arms (2)

iv Ketamine

EXPERIMENTAL

Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM)

Drug: Ketamine

Sufentanil

ACTIVE COMPARATOR

Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)

Drug: Sufentanil

Interventions

Sufentanil DRUG

Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)

Sufentanil

Ketamine DRUG

Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)

iv Ketamine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 75 yrs
• class ASA I, II or III
• lung surgery

You may not qualify if:

• Contra-indication to the achievement of epidural analgesia
• Preoperative chronic pain,
• Contra-indication to ketamine
• Hypersensitivity to ketamine or any excipients
• Uncontrolled hypertension,
• Stroke
• Heart failure
• Hepatic porphyria
• Contra-indication to sufentanil
• Hypersensitivity to sufentanil, opioids or any excipients
• Treatment with an opioid agonist-antagonist,
• Contra-indication to levobupivacaine
• Hypersensitivity to levobupivacaine, local anesthetics of the amide or any excipients
• Hypotension, shock

Sponsors & Collaborators

• Hopital Foch: lead

Study Sites (1)

Hopital Foch

Suresnes, 92150, France

Location

MeSH Terms

Interventions

Sufentanil; Ketamine

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2011
• First Posted: March 22, 2011
• Study Start: September 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

FR (1)