Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Thoracic Surgery Clinical Trial

Official title:

Thoracic Epidural Analgesia: Epidural Levobupivacaine and Sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01320475
• Other study ID #: 2009/04
• Status: Terminated
• Phase: Phase 4
• First received: March 19, 2011
• Last updated: September 22, 2016
• Start date: September 2010
• Est. completion date: July 2011

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• age between 18 and 75 yrs

• class ASA I, II or III

• lung surgery

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Drug:
• Sufentanil
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)
• Ketamine
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)

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of an adverse event due to the analgesic protocol		one week	Yes
Primary	Efficacy of the analgesic regimen		third postoperative day	No
Secondary	postoperative rehabilitation		two weeks	No
Secondary	postoperative complications (pulmonary, others)		one month	No
Secondary	length of stay		one month	No
Secondary	patient's satisfaction		sortie de l'hopital	No
Secondary	Occurence of a chronic pain		end the first postoperative year	No