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RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Randomized Controlled Trial Comparing Post-VATS Analgesia Between Patients With an Intrathecal Injection of Morphine and Sufentanil Versus Placebo.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02152514
Enrollment
34
Registered
2014-06-02
Start date
2013-04-30
Completion date
2015-05-31
Last updated
2016-01-20

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

Conditions

Thoracic Surgery, Video-assisted, Postoperative Pain, Rachianesthesia, Sufentanil, Morphine

Brief summary

The purpose of the study is to determine if the administration of a mix of Sufentanil and Morphine in intrathecal is a better analgesia regimen than PCA alone in patient post-VATS.

Detailed description

This study will compare the need for analgesia (Hydromorphone PCA) of two groups of patients post-VATS. The placebo group will only have a PCA for post-operative analgesia, witch is the standard care for patient post-VATS. The experimental group will have a intrathecal injection of a mix of morphine and sufentanil before the induction of anesthesia.

Interventions

DRUGIntrathecal Morphine/Sufentanil
DEVICEPCA

Sponsors

Université de Sherbrooke
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* VATS * ASA 1,2 or 3 * Minimum weight of 50 kg * Patient able to consent

Exclusion criteria

* Patient refusal * Patient unable to understand PCA * Contraindication to rachianalgesia * Zona * Pregnancy * Over 30 mg of morphine during the last 24 hours * Use of Pregabalin, Gabapentin, Doluxetin, Amitriptyline or NSAI in a context of chronic pain * Severe allergic reaction to morphine, hydromorphone, sufentanil or local anesthetic * Intubation over 1 hour after surgery (unability to use PCA) * High risk of conversion to thoracotomy * Unable to perform rachianalgesia due to technical difficulties

Design outcomes

Primary

MeasureTime frameDescription
Hydromorphone consommation24hrThe amount of Hydromorphone needed by the patient in the first 24hr after his VATS.

Secondary

MeasureTime frameDescription
PainEvery 4h x 24hrA VAS will be used.
Adverse effects of narcoticsEvery 4h x 24hrIncluding : * Saturation \[Saturation (%) and the need for oxygen (l/min) will be assess to evaluate the incidence of desaturation and hypoventilation in both arms\] * Sedation \[Sedation will be evaluate with the Riker Sedation Agitation Scale\] * Respiratory rate \[To evaluate the incidence of hypoventilation (\<8/min) and to compare the average between both arms\]
Adverse reactions associate with rachianesthesia24hrIncluding : * Backache * Headache * Legs strength
Adverse reactions of narcotics24hrIncluding : * Nausea * Pruritis * Urinary retention

Countries

Canada

Outcome results

None listed

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