Sensorial & Physiological Mechanism-based Assessments of Perioperative

Status Terminated

Clinical Trial Summary

The overall goal of this proposal is to determine if quantitative sensory testing (QST) assessing pain modulation can be used as a clinical tool to optimize perioperative pain management. The central hypothesis is that the identification of patient's sensory pain profile allows personalizing therapeutic approaches to improve individualized pain management and thus prevents pain chronicity.

Clinical Trial Description

The primary objective of this study is to evaluate if pre-operative QST can identify if patients will have high pain intensity peri-operatively and at 6 months post-operatively. Evaluation of the intensity and chronicity of pain and the function of the descending inhibitory system through a short QST procedure before surgery and six months after surgery will be carried out. In addition, evaluation of the patient's physical and emotional functioning, and exploration of the potential biological underlying mechanisms will also be assessed at the same time points. The secondary objective of this study is to determine if the peri-operative use of an alpha-2 adrenergic receptor agonist enhances the efficacy of the descending inhibitory system of patients with sub-optimal CPM efficacy before surgery by decreasing pain after surgery. Consequently, this pharmacological intervention may also reduce the incidence of acute and chronic pain after surgery. Evaluation of the pain intensity and the function of the descending inhibitory system through a short QST procedure six weeks after surgery and six months after surgery in patients receiving Clonidine or placebo during the perioperative period will be done. In addition, evaluation of the patient's physical and emotional functioning, and exploration the potential biological underlying mechanisms at the same time points will be assessed. Lastly, evaluation of potential biomechanical alterations in 3D related to pain in children reporting presence of back pain pre and post spine surgery will be looked at. The hypothesis is that patients undergoing spine surgery with poor inhibitory pain response will have less pain in the immediate and long-term period when treated prophylactically with Clonidine in the perioperative period. ;

Study Design

Related Conditions & MeSH terms

Scoliosis

Clinical Trial Details

NCT number	NCT03537612
Study type	Interventional
Source	Shriners Hospitals for Children
Contact
Status	Terminated
Phase	Phase 3
Start date	June 22, 2018
Completion date	April 5, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Sensorial and Physiological Mechanism-based Assessments of Perioperative Pain — RCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms