Epidural Levobupivacaine-sufentanil Versus Epidural Levobupivacaine and Intravenous Ketamine

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01320475

Enrollment

Registered

2011-03-22

Start date

2010-09-30

Completion date

2011-07-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery

Keywords

thoracic epidural analgesia, epidural opioid, ketamine, adverse effect

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.

Interventions

DRUGSufentanil

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)

DRUGKetamine

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Occurrence of an adverse event due to the analgesic protocol	one week
Efficacy of the analgesic regimen	third postoperative day

Secondary

Measure	Time frame
length of stay	one month
postoperative rehabilitation	two weeks
Occurence of a chronic pain	end the first postoperative year
patient's satisfaction	sortie de l'hopital
postoperative complications (pulmonary, others)	one month

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026