RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

NCT02152514 | Terminated Phase 4

• 1 other identifier: Epimorph for VATS
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hydromorphone consommation

  The amount of Hydromorphone needed by the patient in the first 24hr after his VATS.

  24hr

Secondary Outcomes (4)

• Pain

  Every 4h x 24hr

• Adverse effects of narcotics

  Every 4h x 24hr

• Adverse reactions associate with rachianesthesia

  24hr

• Adverse reactions of narcotics

  24hr

Study Arms (2)

Intrathecal Morphine/Sufentanil and PCA

ACTIVE COMPARATOR

Patients will receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will have a PCA for analgesia rescue in the post-operative period.

Drug: Intrathecal Morphine/Sufentanil; Device: PCA

PCA alone

PLACEBO COMPARATOR

Patients will NOT receive an intrathecal injection of Morphine 250 mcg and Sufentanil 10 mcg before the induction of anesthesia. They will only have a PCA for analgesia in the post-operative period.

Device: PCA

Interventions

Intrathecal Morphine/Sufentanil DRUG

Intrathecal Morphine/Sufentanil and PCA

PCA DEVICE

Also known as: Patient Controlled Analgesia

Intrathecal Morphine/Sufentanil and PCA; PCA alone

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sufentanil; Passive Cutaneous Anaphylaxis; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Analgesia; Anesthesia and Analgesia

Study Officials

• Yanick Sansoucy

  Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: May 23, 2014
• First Posted: June 2, 2014
• Study Start: April 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2016-01

Locations

CA (1)