RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02152514
• Other study ID #: Epimorph for VATS
• Status: Terminated
• Phase: Phase 4
• First received: May 23, 2014
• Last updated: January 18, 2016
• Start date: April 2013
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• Intrathecal Morphine/Sufentanil

Device:
• PCA

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydromorphone consommation	The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.	24hr	No
Secondary	Pain	A VAS will be used.	Every 4h x 24hr	No
Secondary	Adverse effects of narcotics	Including : 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]	Every 4h x 24hr	Yes
Secondary	Adverse reactions associate with rachianesthesia	Including : Backache; Headache; Legs strength	24hr	Yes
Secondary	Adverse reactions of narcotics	Including : Nausea; Pruritis; Urinary retention	24hr	Yes