RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Université de Sherbrooke

Status and phase: Terminated; Phase 4

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

Treatments: Device: PCA; Drug: Intrathecal Morphine/Sufentanil

Study type: Interventional

Funder types: Other

Identifiers

NCT02152514

Epimorph for VATS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

34 participants in 2 patient groups, including a placebo group

Intrathecal Morphine/Sufentanil and PCA

Active Comparator group

Description:

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.

Treatment:

Drug: Intrathecal Morphine/Sufentanil

Device: PCA

PCA alone

Placebo Comparator group

Description:

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.

Treatment:

Device: PCA