RCT Comparing Analgesia Post-VATS With Epimorph VS Placebo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Three Different Pain Blocks for Subjects Undergoing VATS (Video Assisted Thoracoscopic Surgery) Procedure.

NCT03151434

Video Assisted Thoracoscopic Surgery Pain, Postoperative Pain, Acute

COMPLETED PHASE3

Continuous Thoracic Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

NCT02670759

Postoperative Pain

TERMINATED NA

Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy

NCT01700491

Hypotension

TERMINATED PHASE3

Effects of Thoracic Erector Spinae Plane Blockade on Acute and Chronic Pain After Video Assisted Thoracoscopic Surgery (VATS)

NCT04208542

Thoracic

UNKNOWN PHASE4

Paravertebral Catheters for VATS Procedures

NCT02361775

Acute Pain

COMPLETED EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thoracic Surgery, Video-assisted Postoperative Pain Rachianesthesia Sufentanil Morphine

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathecal Morphine/Sufentanil and PCA

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.

Group Type ACTIVE_COMPARATOR

Intrathecal Morphine/Sufentanil

Intervention Type DRUG

PCA

Intervention Type DEVICE

PCA alone

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.

Group Type PLACEBO_COMPARATOR

PCA

Intervention Type DEVICE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intrathecal Morphine/Sufentanil

Intervention Type DRUG

PCA

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Patient Controlled Analgesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No